What does it take to be an expert in fermentation?
This article was originally published on 27.1.2016 and has now been updated with new information.
Teva api utilizes exceptional fermentation production capabilities, technologies, processes and R&D services to meet the highest industry standards.
We operate state-of-the-art, high-capacity fermentation plants with total fermenter capacity of nearly 2000 m3. Operated by skilled and experienced professionals, these fully-automated production plants implement complex fermentations, including highly-controlled fed batch and bioconversion processes even in 100 m3 bioreactors, and the subsequent recovery processes.
Beside the traditional fermentation operations, the most complex upstream and downstream processes can be handled by our equipment and experts.
Our proven fermentation production capabilities cover a broad range of technologies and classical fermentation products from antibiotics, statins, antifungal compounds and immunosuppressants to enzymes and high-potent compounds.
Teva api provides industry-leading R&D services throughout the product lifecycle. Our R&D expertise includes strain and technology development processes designed to continuously improve process productivity and product quality for both new compounds and existing products.
We have a high-level experience in strain improvement, upstream and downstream process improvement and process scale up from laboratory to pilot and further to production scale.
Strain improvement activities incorporate both modern molecular/genetic and classical methods that deliver the most robust and productive strains for commercial scale. Organism types vary from bacteria and filamentous fungi to recombinant enzyme production hosts.
We have extensive experience developing classical and modern biotechnological, enzymatic and whole-cell bioconversion processes involving multidisciplinary teams of molecular biologists, microbiologists, bioengineers, enzyme and process chemists.
Fermentation over the years
The Teva api Debrecen site has more than half a century of experience in the development, scale up and production of classical fermentation products. Over the years, the Teva api fermentation team has led multiple process scale up and technology transfer projects that have strengthened our competencies in related areas such as QA and regulatory compliance.
Our R&D and production experts cooparate closely to ensure our processes operate at peak efficiency and at the highest quality all the time.
By fully utilizing our deep expertise of the fermentation production process – from cellular pathways to engineering practices – we are able to handle even your very specific and complex needs.
This article was originally published on 27.1.2016 and has now been updated with new information.
A growing number of pharmaceutical products contain highly potent active pharmaceutical ingredients (HP APIs) – molecules that are proven to be effective at much smaller dosage levels than traditional APIs, usually at mg scale and below.
The HP APIs are classified based on their toxicity, pharmacological potency and occupational exposure limits (OELs).
During the last decade, the demand for HP APIs has rapidly increased, mainly because of advantages in clinical pharmacology and oncology research. The overall HP API market is predicted to grow at approximately 10% per year, with about 25% of drugs already on the market today formulated with HP APIs.
The largest percentage of HP APIs is intended for the treatment of cancer: it was estimated that there are nearly 290 small-molecule targeted therapies currently under development against cancer.
These APIs are frequently characterized by complex structures requiring multi-step processes or semi-synthesis, often involving more than 10 synthetic steps.
The development and production of highly potent compounds, in fact must be achieved in a manner that protects researcher, operators and the environment from exposure to the HPAPIs and, in multi-product facilities, minimizes any risk for cross-contamination when switching from one product to another.
Expertise in synthetic organic chemistry, process development and optimization, purification capabilities, and highly sensitive analytical instrumentation and techniques, are to be performed under conditions that minimize the exposure to dangerous material.
Highly potent API development and manufacturing require specialized approaches in facility design, equipment selection and manufacturing processes to achieve desired levels of high level containment.
High Potency Manufacturing
At Teva api, our long tradition of highly potent product manufacturing dates back to the 1980s.
Initially, the focus at our HP sites was on steroids and steroidal hormones; subsequently, we added APIs that can be used in oncolytic drugs, muscle relaxants (anesthesia), immunomodulating drugs and drugs for pulmonary diseases (e.g., COPD and asthma) and HPAPI for Antibody-drug conjugates (ADCs).
Placing patient health as a top priority, Teva api prevents any risk of cross contamination with chemical entities active at the µg (microgram) level by operating four dedicated production lines based on our four areas of focus.
Today Teva api operates several HP sites. Teva asset includes specialized HP API R&D labs, pilot and finally launch and commercial scale production facilities.
In addition to fulfilling industry needs for injectable and respiratory drugs, Teva api also has implemented lyophilization (freeze-drying) and micronization processes at commercial scale.
Sourcing the Raw Materials for an API — How it’s Done!
How does an API company source raw materials during early development stages? Where do the raw materials come from and how do we ensure our suppliers are reliable?
It is all in a day’s work for Sharon Millrod, Senior Director, Head of Teva api Category Management, R&D Sourcing & Biologics and his global procurement R&D sourcing team. In this blog, we’ll discover what it takes to find the right starting materials to get an API off the ground and ready for mass production.
The early beginnings
Producing 350 active pharmaceutical ingredients is no easy feat. And it all starts with the 6 research and development (R&D) sites that Teva api has around the world. Once a product is approved for development, Sharon and his team jump in and begin sourcing the main starting materials and advance intermediates – which are the main building blocks in API production.
Their role is to support all stages of R&D, from initial feasibility lab trials until the API is launched in the main market — that’s many years of support! It starts with a few grams of starting materials for initial lab samples, then larger amounts for non-GMP pilot production, and finally GMP raw material for the scaled-up process in one of Teva api’s commercial GMP production sites.
Once an API ‘goes commercial’, the responsibility is transferred from Sharon’s team to the local procurement teams in Teva api’s commercial production site, who will continue the relationship with the suppliers that has been created and nurtured during development.
Reliability is key
The main goal of the team is to find reliable, high compliance, cost competitive, strategic suppliers from day one. The procurement team has a solid, comprehensive selection process in place to identify reliable partners to ensure smooth launch and supply in the long run.
In addition, the team ensures a minimum of two suppliers for each material needed. In the case of a single source, they always push to approve a second source to reduce future supply disturbances. “We have to make sure we don’t have all our eggs in one basket”, says Sharon.
“This means a minimum of two different suppliers for each starting material and intermediate, in two different geographic locations. We’ve always known it, but the corona pandemic has proven that’s it’s always better to have options.”
The thorough interview process
Teva api works with around 700 raw materials suppliers, and of these, approximately 200 are suppliers for starting materials. Once the procurement team gets the list from the R&D team of what they need to source, they work with both public and private databases and the Teva api local procurement offices, to start the process of finding reliable suppliers.
Questionnaires are sent to the companies of interest, to get a broad sense of who they are and their background. The questionnaire covers everything, from financial, EHS, compliance, and regulatory information. It also has product specific questions, such as: how many customers do you have, what’s your scale up, how many batches do you produce, what are the prices, how many suppliers do you have for your starting materials, and do you sign quality agreements for your starting materials.
The suppliers are then scored using specific metrics. Samples are tested internally by Teva api’s Quality Control and MS&T departments, and are audited by the QA team to get final approval.
It’s a lengthy process, but evidently one in which each part is necessary and valuable.
The China Crisis and what it means for procurement
It’s not just the day-to-day sourcing that keeps Sharon on his toes. It’s also global changes and challenges that are making their impact on the pharmaceutical industry.
As the world slowly emerges from the pandemic, there’s been an upsurge in economic activity but a new set of challenges. Logistics prices have gone up, in large part due to stuck containers at sea or at ports and a lack of manpower to offload from the ships; solvents prices are going up, and the energy sector is experiencing high demand and a shortage of energy sources.
The Teva api procurement team are keeping their eye on the pulse and constantly seeing how they can mitigate the risks to supply.
The team is also working with the global supply chain team internally, to map all single-source Chinese suppliers, and mitigate the risk by approving alternate suppliers from other countries. They are also looking to produce starting materials in house.
Being on the procurement team is certainly quite the job, but clearly the global procurement R&D sourcing team know what they’re doing and are doing it well!
Check out our latest podcast, Respiratory APIs: a peek into the lab with our experts, where we deep-dive into the challenges of respiratory APIs. We join Dr Ales Gavenda, Director of R&D in Czech Republic and Italy, and Oshrat Frankel, our Head of New Technologies, Innovation and Pre-formulation, for a guided tour.
Or find us on your favorite podcast app!
If you prefer the written word to the spoken word, here’s an outline of the podcast.
The Market for Respiratory APIs
The chemical, physical and bulk properties of APIs for respiratory formulations are especially important and dramatically influence on the behavior of the API during the formulation process, and more importantly the performance of the drug product during treatment.
Over the last few decades, there has been a huge growth in the number of non-cancer respiratory diseases. Asthma medication for example is projected to rise from 10% of the respiratory market in 2019 to 23% by 2024, while other Asthma or allergy related medication will rise from 21% to 26% during the same time period. According to GINA, it is estimated that – asthma affects ~350 million people worldwide, 25MM+ in the US alone, including 6MM children. On top of that, COPD is estimated to impact 310MM people in the world, with 13MM in the US diagnosed, and 24MM with impaired lung function.
At Teva api, the R&D team is deeply engaged in developing a variety of respiratory APIs. This includes thinking about formulation, suitability to the relevant devices, stability and much more. It all starts with R&D.
Unique Challenges of Respiratory APIs
Respiratory drugs present a unique set of challenges, because most of them are delivered through inhalation as powders. That means that the API has to be broken down into fine particles through a process called “micronization”. Once developers have created a suitable powder, the next issue is finding the right delivery device to get it into the lungs.
Oshrat explained to us how crucial it is to choose the right delivery device. There are a few types of devices:
Dry powder inhaler (DPIs) that contain a powder made up of the API and a carrier, usually lactose particles, which gets the medicine into your lungs. The patients inhales a really big breath in, so that the full dose gets to their lungs. This can be challenging for many patients.
Metered dose inhalers (MDIs). a blast of medicine is delivered by pressing a button. They are aerosol powered and deliver a fixed dose using an HFA, or hydrofluoroalkane, propellant. They are very accurate as they deliver the same dose every time.
Soft mist inhalers which create a cloud of medicine that can be inhaled without the help of a propellant or lactose.
While in regular medicine the API doses might range from several milligrams to around one gram, in the respiratory APIs administered by inhalation, doses are tiny, usually only a few micrograms – which is hundreds of thousands, if not up to a million times smaller than a regular API dose. That is a challenge for many of the API companies. These highly APIs allow a much smaller margin of error when developing products for specific inhalation devices. We, at Teva api, have a range of techniques to do full physical characterization and beat this challenge.
Understanding Particles for Respiratory APIs
One of the most important things to think about for respiratory APIs is the shape of the particle. Obviously, API particle shape and size will impact particle surface area. This is called, Morphology.
For example, some particle shapes, like needle shapes, don’t stick very well to the carrier used in the dry powder inhalers. That means they often don’t reach the right part of the lungs. The more suitable shape for respiratory API is a round shape or regular shape particles which has optimized aerodynamic properties, so we can expect they reach the right place in the lungs.
Another thing to consider is particle size. The idea is to create just the right size of particle to reach the right place in lungs and be deposited there effectively. So for DPI formulation, for example, particles with a mass median aerodynamic diameter of below 10 micrometers are ideal.
Those particles reach the right part of the lungs, through the bronchial tree and alveolar regions, and are deposited there. Any larger, and the particles end up stuck in the airways or mouth, or even swallowed. Any smaller and they tend to be exhaled before they’re deposited, which means that they don’t have a chance to work.
In the end, the majority of all respiratory particles of API are lost this way. Of course these variables cannot be eliminated, and they need to be considered when developing the API drug substance.
Other important Factors in the Respiratory API Process
But it’s not only the shape and size of particles that matters. All sorts of other factors need to be examined during the development process. For example, most drugs come in a crystalline form, and could potentially exist in many forms. These are known as “polymorphic forms” and there can be huge differences between them, which have significant implications for pharmaceutical applications — everything from physical properties, product stability, solubility to formulation aspects.
This has a huge effect on how the drug works — how effective it is, e.g. bioavailability. It’s also important to look for amorphous traces, which are traces of non-crystalline material with potential impact on API solubility and stability. Obviously amorphous content needs to be controlled.
At Teva api, we quantify it via various analytical instrumentation e.g. thermal techniques like modulated differential scanning calorimetry, microcalorimetry and others to measure amorphous content in our products. However even more important is to set micronization parameters in order to minimize amorphous matter creation.
In addition, we have developed specific processes how to remove amorphous matter from the final product. This is a unique know-how which makes our final API much stable in terms of physical properties during manufacturing and its storage.
Micronization
To ensure the right particle size, the API goes through a process of micronization, which means breaking down bigger crystals into a fine powder.
At Teva api, our scientists and engineers are always working to optimize our particle size reduction techniques. Because we perform this development internally, it gives us better control over the process, and also greater flexibility. Really it’s about being able to tailor solutions to each customer’s exact needs.
The first point for perfect micronized product is consistent crystalline API input for milling or micronization. For that we optimize crystallization in all aspects in order to have robust crystallization process and consistent particle size and morphology.
Our Center of Expertise in Europe has various technologies for size reduction available in one place. Among our technologies are various types of milling and micronization with QbD approach. Our experienced experts are exploring all possibilities to find the right technology and equipment for our products. When we find the optimal technology and conditions, we perform technology transfer to production site and verify again the final product quality.
Since particle size is so -important for respiratory drug product, we can provide tailor-made particles for each customer‘s formulation development. We can provide several grades of particle size for testing the right target during pharmaceutical development. Once the right particle size is found adequate for formulation, we continue to work on monitoring other physical properties.
Flowability
Flowability means whether particles flow freely over each other. This is tested by a special machine called a powder rheometer. By measuring the powder’s resistance to the probe, you can see whether the API flows well and is suitable for formulation, or tends to stick together, which can cause some trouble during formulation and storage. Examining bulk and tap density is also crucial and may impact how the powder will behave during processing and storage.
All the research coming out the industry confirms how important all of these processes are in developing respiratory APIs. For more information, make sure to check out the full podcast right here!
Respiratory APIs & The Teva api Advantage
Teva api has a variety of respiratory APIs and our R&D team is invested in developing an in-depth understanding of the formulated API. We look at everything from manufacturability and stability to legal issues, and factors that could affect formulation development. We offer a complete support package on the sales side of things, but that obviously has to begin with research and development.
We have approximately 15 different respiratory APIs across all therapeutic categories, making us a leading supplier in this sector. The respiratory segment is a hugely important one right now. So we’re really going the extra mile.
All our respiratory APIs are produced in state-of-the-art facilities both in R&D and in production. We can work with highly potent APIs, including steroids. We have the personnel, the expertise, the equipment, and decades of scientific experience. Tools such as Design of Experiments methodology, computational tools, modelling, and Process Analytical Technology help the team design, analyze, and tightly control manufacturing processes. And this ensures the highest quality products.
Our respiratory portfolio has been the largest in the industry for some time, and we’ve just added four newest products for pharma R&D development. You can reach out to us to learn more on those products.
This is the second episode in our podcast series, The World of the APIs, where we speak to the scientists and experts who make the APIs happen.
In India, a unique challenge faced the leadership due to the country’s sheer size and diversity of Teva’s operations and business units. This blog will discuss the journey of the India Situation Room (ISR), and the measures that were (and are still being) taken to provide employees with a safe and comforting environment during these unique times. It will also describe the actions implemented to ensure the continuous delivery of much-needed medicines around the world.
The India challenge
Being that Teva operates in the ‘essential services’ industry, the team was driven with the objective of providing a working and sustainable solution for employees during these extraordinary times, the India Situation Room was set up to ensure the safety and health of all Teva employees in India, and to maintain business continuity for our India-based operations.
With 11 sites across six Indian states, this operation was certainly no easy feat to get off the ground. The ISR consists of more than 25 people in the leadership team, including all the site leaders and work stream leaders from all our facilities in India. In addition, each site, in each location, established its own Site Situation Room led by the individual site leader.
General COVID-19 guidelines come from Teva’s Global Situation Room, and are then reviewed by the ISR and synced with the Indian Government’s guidelines.
Powering on while keeping safe at Teva India
Essentially, there are two main objectives of the ISR. The first is to safeguard the health and safety of all employees, contingent workers, and contractors. Without the people, nothing can continue.
The second main objective is so ensure Teva’s resilience — business must carry on, come what may, so that patients don’t end up losing out. With these two objectives in mind, the ISR had, and still has, multiple key tasks facing them.
Have one consolidated approach of existing and potential threats, opportunities, and mitigations aligned with local India government and Teva corporate guidance.
Take care of the health and safety of employees (especially those diagnosed with Coronavirus), the community, and the business.
How we do it
Leaders constantly touching base
The India Situation Room had a mandatory meeting each morning to review the situation as the virus was spreading across the country and the lockdown being imposed. The team worked hard to establish a leadership tone that balanced the two main objectives of safety for employees and business continuity. These calls have now become weekly, as we’ve become more familiar with the situation and how to deal with it.
Daily ‘safety moments’ are a core element of these calls. Each leader takes a turn to give a short presentation on a safety-related topic, raising awareness on the constantly changing situation and the proper response to it. These ‘moments’ range from discussing employee health and sanitization methods to product/service safety.
Building the medical/health infrastructure
The team stayed ahead by equipping the medical doctors & staff in the Occupational Health Centers in each of the manufacturing sites to respond better in case of an emergency and to ensure a safe environment for employees.
For example, pulse oximeters were procured, as well as temperature guns and other special personal protective equipment.
Creating proper protocols
Protocols were created for employees returning to work after having the coronavirus, as well as for cases that are suspected or confirmed. Mock drills were also organized. Throughout this period, and especially during the beginning months, the Occupational Health Center staff worked on building up their emergency response capabilities.
Keeping the information flowing globally
It’s been hugely important for us to keep the global team up to date about the situation in India, and in turn, we’ve benefited from a seamless flow of guidance and information – resulting in employee safety and healthy site operations. The global team has aided the India team in providing support to each person suspected of having the virus, or those who actually did contract it. The empathy given also helped employees overcome any stress in these disruptive times.
Risk assessing new technologies
With the advent of the pandemic, many new technologies mushroomed in the market. Some of these were not adequately tested for efficacy or safety on employees’ health & safety. The team evaluated each of these for its efficacy before deciding whether to implement it or not.
For example, the team proactively evaluated the sanitization tunnels spraying the disinfectants and decided against the implementation. It was also discontinued by the government and others where it was implemented and thus validating the keen evaluation by the India Situation Room.
The team proactively evaluated this technology and decided against the implementation. It was later discontinued by the government and other companies where it was implemented, thus validating the ISR’s decision.
Inspiring confidence in our employees
The situation in India hasn’t been easy. Different states have been affected differently which has an impact on our operations. Due to the population density in India, COVID-19 has been extremely intense. India was one of the few countries that announced an early and extended lockdown, with an interstate lockdown within the country.
There’s also a huge diversity of population, with a stark contrast between rural and metro India and the levels of awareness on COIVD-19 between the two. All these factors have placed a strain on workers across the board – whether at Teva or elsewhere.
This unified Teva approach in responding to the situation — the leadership tone, transparency and commitment by all during these times helped instill a strong safety culture across the sites. Openness to hear employee’s ideas, suggestions and concerns through various channels such as open houses, one-on-one meetings, and town halls has helped instill this safety culture.
Some ‘smaller’ actions that were implemented included safety-themed posters, in both English and the local language, that were put up everywhere; mock-drills took place to practice for all sorts of COVID-related scenarios; and a ‘Zero Contact’ drive took place to ensure social distancing among employees.
Another extremely impactful initiative that was implemented was introducing insurance programs for all workers (both employees and contractors), that guaranteed them solid cover in the event of contracting the virus. During the lockdown, food and other basic necessities were also provided to those workers who needed it, as well as transportation to get to and from work. We’ve heard from many workers that, without this aid, they simply wouldn’t have managed and/or felt comfortable coming in to work.
This culture of ‘caring’ supported employees and the contingent workforces with appropriate medical support and addressed the basis needs during the lockdown, thus creating a rewarding environment.
Teva during these extraordinary times extended support to the migrant population that was stranded during the lockdown with food, stood by the medical fraternity by providing PPEs and helped the contingent workers with grocery supplies. The outreach programs not only created impact on the society but also helped building awareness and commitment to providing a safer environment for each other.
Looking ahead…
In these unprecedented and challenging times, the India Situation Room has done, and is still doing, a commendable job of coming together and facing whatever daily challenges crop up.
The ISR platform has paved the way for sites, cross-functional teams, and individuals to work together, strengthen our systems, and reduce risk to safety, health and welfare all round.
The sheer magnitude of this cross-business operation, and the subsequent success of it, has prompted India’s leaders to take this working model forum forward. In the last couple of months, a Crisis & Business Continuity Management Team has been established, with the aim of providing business continuity planning guidance to sites and teams across India.
Start getting ready for 2020 with Teva api at CPhI Worldwide
It’s almost that time again – time to visit CPhI Worldwide and head to the Teva api booth for news on all the latest pipeline products, plus outstanding expert insights, advanced new services, and maybe even a tasty, refreshing shake. We’re looking forward to seeing you there!
Simply the largest exhibition in the pharmaceutical industry, CPhI Worldwide is more than a trade fair – it’s an entire world buzzing with services, solutions, and some 45,000 pharma professionals from all over the globe. It’s also Teva api’s natural habitat, so we are delighted to be attending CPhI Worldwide 2019 in Frankfurt, November 5-7 at hall 6, booth 60F31.
Consistently recognized among the most trusted API suppliers, Teva api has a lengthy track record of product quality, expertise, and sterling service dating back over 84 years. We serve more than 1,000 customers in over 70 countries, with the industry’s broadest portfolio of almost 400 products, manufactured at 17 International sites.
As has become an annual tradition, Teva api will be using CPhI Worldwide as the ideal platform for showcasing its upcoming products, while also offering customers the opportunity to meet and collaborate with an impressive lineup of multidisciplinary experts. Simply drop by Booth60F31 or arrange a meeting to make sure you stay in the loop.
special preview of the latest Teva api products
CPhI Worldwide is always a highlight on the industry calendar, and we are pleased to report that it will both cap a very successful year for Teva api and lead into what is sure to be a similarly productive 2020.
This year, we will be unveiling 10 new APIs for the following indications:
Baricitinib – rheumatoid arthritis
Dalbavancin – antibiotic
Baloxavir Marboxil – flu
Larotrectinib – anticancer
Acalabrutinib – anticancer
Lorlatinib – anticancer
Letermovir – HCMV infection
Brexanolone – postpartum depression
Oritavancin – antibiotic
Siponimod – multiple sclerosis
All our APIs are developed and produced under exacting conditions at ultramodern plants worldwide, in strict compliance and cooperation with the FDA, EMA, as well as additional local authorities. Teva api, as a division of Teva Pharmaceuticals, was recently awarded an EcoVadis Silver Medal in recognition of our responsible conduct in environment, labor and human rights practices, ethics and sustainable procurement – putting us in the top 16% of all pharmaceutical companies. As ever, our dedicated API experts will be on hand to fill you in and answer your questions about any or all of our new products. Contact us here as soon as possible to schedule a meeting.
Meet Teva api’s leadership
While many of you have already been in contact with our regional sales managers, CPhI offers the unmissable opportunity to meet Teva api’s sales leadership face to face and discuss new opportunities for collaboration. Current and potential customers alike are invited to schedule a meeting with our highly experienced executives, who can provide unique insights on a variety of relevant issues. In attendance this year will be Mrs. Kerri McCullough Wood, SVP & Head of Commercial, as well as Mr. Uri Gat-Palash, Senior Director, Head of EU Sales, Ms. Moran Eshel, Product Management Director, Mr David Seignolle, VP Teva api Supply Chain Management, Nimrod Bar-Zvi Head of Teva api Sales in Americas and China, and also a team of expert account managers who will all be happy to introduce you to Teva api’s broad portfolio of products and services. On the regulatory side, Dr. Tal Harel, our Global Regulatory Affairs Director, will be on hand to help you navigate complex regulatory issues, while Dr. Augusto Canavesi, Head of New Products Management, is just the person you need to address diverse R&D inquiries.
“CPhI Worldwide highlights the very best of the pharmaceutical industry and is a fantastic opportunity for pharma professionals to discover everything Teva api has to offer. I’m looking forward to meeting customers old and new, and discussing a whole world of opportunities with them in Frankfurt.” – Kerri McCullough Wood, SVP & Head of Commercial
Our experts are sure to be in great demand, so please contact us here or reach out to your account manager to arrange a meeting in advance.
Advanced API sterilization service
Teva api recently added innovative aseptic sterilization services to its extensive portfolio, offering yet more convenience and top-notch quality to customers worldwide. Our brand new facility was launched at the end of 2018 and has already become a major factor for many customers when selecting their API supplier. Fully FDA approved, this state-of-the-art facility uses the aseptic filtration technique, which avoids damaging the API (essential for sensitive products) or forming new impurities. An on-site microbiological lab eliminates any possibility of contamination, and we also utilize dual packaging to ensure total sterility of the supplied API. For more details, please read our white paper or visit Booth 60F31 to get all the details from our R&D and regulatory experts.
Shake things up at the Teva api booth
Visiting CPhI is always a thrilling, informative experience, but we know from experience that a full day of meetings and presentations can quickly drain your energy. Thanks to Teva api’s customer-centric approach, we’d like to invite you to Booth60F31 for a tasty energy boost! Everyone who drops by our booth will be invited to enjoy a fresh, colorful fruit shake. As you know, we are all about high quality ingredients, and our shakes are no different! Our mini on-site “coffee shop” will also serve up a range of other hot and cold beverages, providing the perfect haven where you can relax, get organized, and prepare to tackle the next few hours of the event.
As you can see, Teva api’s booth is the place to visit for an entire world of industry updates, pipeline information, expert insights, and more. We look forward to meeting and collaborating with you in Frankfurt – and also at CPhI Worldwide 2020 in gorgeous Milan, Italy.
A global API supplier that understands the API industry!
In this short video we are proud to introduce Teva api’s leadership team and provide a glimpse into how Teva api understands the the pharmaceutical industry needs to provide the needed support in international API projects.
Watch this video to see why Teva api is leading the industry and is counted as a reliable and trusted global API supplier and manufacturer – how more than 84 years of experience in the API industry help us understand the market, processes, needed expertise and technologies, and more, so you can have an Active Pharmaceutical Ingredient partner that you can rely on – watch this video!
We invite you to explore the following pages to get to know Teva api better:
Teva api at DCAT 2019 – Looking forward to meet with our partners and introduce our executives as part of our journey together
In our view DCAT Week is the key event for companies engaged in pharmaceutical development and manufacturing. As always, the event will take place in New York, from March 18 -21, 2019. Here you get a golden opportunity to meet Teva api ‘s team, expand your network, connect with Teva api ‘s leading decision makers and get the latest insights from drug manufacturers and suppliers, development and manufacturing services as well as technologies – Wondering what you can accomplish by meeting Teva api ? Read below!
Meet our new President and Executive team to discuss your projects and how we plan to support you better
After the success of last year’s DCAT, TAPI has decided to go two steps further by bringing several members of the top management to the event. In New York you can meet:
Mr. John Nason, President, TAPI & Biologics Operations
Ms. Kerri McCullough Wood, SVP, Head of Commercial TAPI and Medis
Mr. Gaurav Mathur, VP, TAPI Asia-Pacific, Israel & Europe Cluster
Mr. Paolo Fiorino, VP,TAPI Italy & Mexico Cluster
Mr. Nimrod Bar-Zvi, Head of TAPI Sales, Americas, China
Mr. Augusto Canavesi, Head of New Products Management
DCAT Week provides you with a unique opportunity to meet TAPI’s top management to discuss TAPI’s future plans to deliver supply sustainability and further enhance TAPI’s position as your API partner, while answering any questions you might have. Our team is there for you! Don’t hesitate to book your meetings with our executives who are most relevant to your area of business – R&D, supply chain, quality, operations etc.
>>> Teva api’s location at DCAT: Lotte New York Palace Hotel, Chairman’s office, 5th floor, suit #1401, #1402, #1426
Get a first glimpse of our future technologies and products
During DCAT the full Teva api team participating in the event, will be sharing our long-term plans in API production in regards to new or existing technologies and how do we adapt to market different market dynamics and requirements.
They will also be announcing Teva api’s long-term plans for operations and production facilities and as usual, introduce our latest new and pipeline products to be launched later this year.
Join us for some fun and a run!
This year we are also proud to sponsor DCAT’s Fun Run in Central Park for the first time ever. As in running, this run symbolizes our hope for a strong, long-term partnership with you, and our understanding of the need to support your projects every step of the way. It is also a great opportunity to meet members of the Teva api team and other runners from the industry under a fun and loose circumstances … the New York City way. The Fun Run offers guided trainers and three route options, so all levels are welcome to join! The Fun Run takes place Tuesday March 19th 6:00 AM to 8:00 AM in Central Park – transportation and running kits are Taken care!
The number of runners will be limited and is on a first-come, first-served basis, so don’t forget to register for the run today if you want to secure your spot! You can sign up and read more about the Fun Run here … and remember to wave at our camera crew on the route.
Book now
DCAT Week is a highly popular event with many visitors from all over the world. The available time slot with Teva api management is filling up fast, so make sure you secure your Teva api one on one meeting members in due time.
We hope you will take full advantage of the opportunity to learn where Teva api is going and how you and your company can benefit from this exciting journey. We look forward to seeing you!
Trends in the API industry that you should be aware of (2019)
Teva api’s 2019 assumptions
The global market for the manufacture and supply of API’s is changing rapidly and there are many factors influencing these changes. But precisely what are the major trends you should know and be aware of, and how can you use them to your advantage? In this article Teva api gives you the latest overview.
Trend #1 – More API growth
Fueled by the aging population and an increase in global access to treatment the pharmaceutical market is growing. Financial and efficiency incentives are driving the pharma industry to outsource an increasingly large share of their API production, whether it is for generic or innovative API.
Insights: API market is expected to grow 5% annually reaching approximately $219 billion by 2023[1]
Trend #2 – More complex API
The newest generation of API’s being developed are extremely complex, these include peptides, high potency API, oligonucleotides, and sterile API. This means that the R&D and certification processes themselves have also become longer and more complicated.
Insights: The category of biological APIs is growing the most1
Trend #3 – More competitive API market place
A multitude of small producers, specializing in manufacturing niche API’s has led to more intense competition despite the growing market.
Insights: 50% of the global supply of API’s are produced in ASIA and is expected to grow at a faster pace than the overall pace of market growth1
Trend #4 – More regulatory & quality demands on API
As the volume of API production from Asia increases, unfortunately so has the number of major issues with quality and compliance. This had led to an increase in regulatory demands primarily from the US, European and Japanese authorities.
Insights: The FDA commissioner announced an enhanced focus to bolster API drug safety and quality[1]
Being aware of these trends is important, but perhaps what is even more important is how to leverage the opportunities they bring. Of course it depends on your current engagement in API sourcing … are you already fully engaged, or are you at the stage of considering a change?
Here is a range of recommendations on how to best use the current trends to your benefit.
The advantages of API sourcing
As the global demand for pharmaceutical solutions is growing, more and more drug companies are feeling the pressure to bring drugs to the market faster and more cost effectively.
API sourcing is often a way to fast track these opportunities by exploring and the leveraging the skills, capacity, knowledge and experiences of the API suppliers.
Perhaps the most far-reaching trend we have witnessed in the market is the move by pharmaceutical companies away from manufacturing their own API’s and a move to outsourcing their API manufacture to third party expert producers.
When selecting an API partner it is important to choose a supplier that has the competencies, scalability and dynamics to meet the increasing demands from authorities throughout the collaboration process.
Teva api has established procedures and tools to support customers throughout the sourcing process, including access to a dedicated account manager as well as access to thousands of regulatory files needed during the sourcing process via Teva api Online – Teva api’s customer platform.
Even complex API’s are being sourced
A key trend in the global API market is increasing focus on innovative formulations in generics development. Demanding conditions call for advanced treatments using complex molecules.
API is no longer constrained to commodity treatments, and leading API manufacturers are pivoting to highly complex technologies such as peptides, oligonucleotides and sterile API.
Teva api is investing heavily in new technologies to create products used to treat complex medical conditions such as cancer and immunological conditions and other rare diseases.
Buying API’s produced in Asia has its pitfalls
More and more of the world supply of API’s will be manufactured in Asia, where the talent pool of engineers and scientists is high and where the cost structure for manufacturing, labor, materials and equipment is relatively low.
There are a number of issues already rising from this eastward migration. Concerns over quality have lead the US FDA and the European authorities to issue fines and import bans due to major issues concerning the quality and most worryingly the falsification of manufacturing and testing data.
Looking at statistics from the past five years, the number of API suppliers to come under scrutiny by the US FDA has increased[1]. As there is a steady increase of API volume there is also an increase of suppliers who like to qualify for the worldwide market leading to, an increase in the number of critical issues found, mostly due to fact that the quality systems of these companies are not yet matured.
Flight to quality
One clear result of the regulatory issues surrounding API production in Asia has been a “flight to quality”, meaning that many pharmaceutical companies have turned to trusted partners like Teva api, to produce their API’s. Until full compliance is possible, most pharmaceutical companies are expected to place their business with API manufacturers who are already used and dedicated to worldwide standards and processes and to resolve issues in the region.
How will these trends influence the future of API production?
These trends may seem rather chaotic. However Teva api sees these trends inevitably meaning closer partnerships between API producers and the pharmaceutical companies. R&D expertise, quality control and product purity are the result of know-how, hard work and common understanding. Data integrity requires the sharing of technologies and customised software. New API’s no matter what technology is used to develop and manufacture, require API producers to enter into very close working partnerships with the pharma companies in order to develop methods of Api production, R&D, certification and product launch. The more complex the nature of the API, the closer the understanding and co-operation between producer and customer has to be. At the core of this relationship is partnership, trust, open communication, a dedication to quality and regulatory compliance and data integrity.
To find out more about Teva api’s global leadership in these fields please click onto your topic of interest to read more:
Teva api have a dedicated team of experts on hand to help you with your API needs. We cannot of course predict the future, and the trends we bring here are a result and analysis of our global presence and the support we provide to most of the leading pharmaceutical companies, but we have outlined in broad terms how we see the market trending. For a more detailed analysis of your particular area of API manufacture, compliance or data integrity please contact us.
[1] The FDA commissioner Scott Gottlieb on Twitter
[1] Transparency Market Research API Market Size Forecast report
