Wendy Paczkowski is based in the Netherlands and has been a supply chain coordinator at Teva api for the last 6 years. Having previously worked in the hotel industry, she draws both similarities and differences between it and the API world!

I worked in hotels and restaurants for over 10 years! I like the interaction with people. When I left that business, I knew I couldn’t just sit in any old office – I needed the people and the dynamism around me. So I moved to an air freight expediter and spent 5 years dedicated to a pharma company, dealing with their shipments. It gave me the feeling and understanding of what comes along with pharmaceuticals and APIs and how they’re rolled out in to the world.

I started at the end of the journey and now I’m back at the beginning – with APIs. After working in the air freight business, I moved to a pharmaceuticals company that dealt with finished doses of oncology products, and medical devices. And then I moved to Teva api. So I’ve really seen the full circle of taking an API to the customer, the customer then turning it into the final dose, and that final dose being distributed around the world. It’s so interesting!

Working with APIs is different to working with pharmaceuticals, in my experience anyway. There are far more regulations and I’m personally dealing with a bigger portfolio of products. There seem to be a lot more steps that need to be considered when getting the API to the customer. I find it very diverse, extremely fun, and challenging! I love being in contact with so many people – from customers to the manufacturing sites to the account managers.

There’s no time to sit back and relax! It’s an extremely challenging job but that’s also the reason I’m still here. I really enjoy the dynamics around the job and the contact with all the people all over the world.
Working in this business makes me feel I’m doing something that matters in the world. It’s something I always think about. For example, with the recent COVID-19 pandemic, it’s been so interesting to see how the challenge of moving medicines and APIs around the world is being handled. And how different countries are managing things differently.
I do miss being in the office. When you’re home for a long time, it gets harder to get in to the workflow. When you’re in an office with your team, your share information more and talk to colleagues. It’s nice having my own office at home but also lonely. Luckily, my customers are very understanding because they’re in the same position, wherever they are in the world. I would say that although this past year, with COVID-19, has brought up a lot of challenges, it’s also brought a lot of opportunities.

I think our biggest challenge is having more demand than capacity. This is when we’re not able to deliver because we simply don’t have the materials. This can happen for a number of reasons, but if the product isn’t there, it’s just not there. And that’s sometimes really hard to explain to the customer, especially as we want to do all we can to help them. But I always feel that the most important thing is to keep my customer informed about what’s going on, so that our relationship is full of trust and honesty.

Together with a colleague, I initiated the ‘coffee table talk’ that the Supply Chain team has once a month. We meet with the entire team from around the world and one person presents their religion or a specific cultural or religious holiday. It’s a very open discussion where everyone can ask questions, and they do! It’s a fun learning experience and has really bonded us as a team.

I think the most important skills for this job are being focused and thinking out of the box. You have to be focused the whole day and be able to handle the stress every once in a while. And being solution-minded is crucial. Although there are rules to follow, there are also always possibilities which you have to explore too.

I have an amazing team and no matter how big the challenges are, we ALWAYS make it happen! I’m so proud to be part of such a team. It’s so nice to work with so many people who are just so dedicated to their role.

TingTing Zhou has been at Teva api for over 12 years and is in charge of sales for the whole of China. Being that China is an emerging market with huge potential, this is quite the responsibility!

I was the first employee to join the Teva api sales commercial team in China. In 2009, the Teva api Beijing office was built and I was the only employee for the first 2 years. Besides normal sales activities, I also covered customer service, supply chain logistics and regulatory affairs (RA) coordination.

We now sell 10 times more products and the team has grown! I’ve built a small team of account managers, and the China office also has a local RA arm now, which makes it a well-functioning team to serve the market here. In addition, we have other functions from all over the world backing the China office, which is a huge relief comparing to where I started.

To me, Teva api is a family. I know a lot of people in all different functions and they also know me. We know how to approach each other to ultimately benefit the Chinese customers, and I really rely on this support. On the surface you see a small sales team but actually there’s a very big family behind us. This is the best part of my role and I really appreciate it.

Numbers are nice but you have to do a lot to make it happen. At the end of the day, we’re just a few people covering a large market. It would be impossible to achieve these goals without the support and backup of the wider team, such as Supply Chain who deal with the order logistics, Customer Experience who help us on order requests, and all the individual sites who we deal with directly so they know what we want and need.

China is one of the largest emerging markets due to its huge population base. Its uniqueness is twofold. First of all, regulation changes very frequently, sometimes even every quarter. China is trying to learn from the regulated markets such as the US and EU but it does take time to catch up. And all the files have to be in Chinese. Secondly, the government is trying its best to lower the costs of health expenses. There have been many healthcare reforms and negotiations with manufacturers to make medicines and healthcare accessible to everyone. This means fierce competition with API costs too.

My team is seen as the liaison between Chinese customers and Teva api. We are responsible for delivering all the updated news regarding regulation, the market, authority requirements, prices, customer requirements, and quality issues, to the related functions at the Teva api headquarters. Our updates have to be immediate so that the other functions know what we’re facing in China and how to support us to fulfil our targets.

The world of science and pharma is amazing. We do have commercial sales but the majority of the time we’re dealing with development projects. My background isn’t chemistry or pharma, but when we are talking to R&D managers from different pharmaceutical companies about technical issues, such as particle size or impurity profile, I find it very interesting. To try to find solutions and finally achieve a sale are the most rewarding moments for me.

To be a professional account manager, you have to have communications skills, both internally and externally. I’ve been building relationships over years, both with customers and with internal Teva api teams. It does take time to learn how to work with the other teams globally and to learn each other’s cultures, but we always try to find a way to work with everyone to make the sales happen. Also, since the dynamics in China are very unique, we have to make sure to convey the differences properly to all other functions, which takes time and good communication! These are skills I’ve obtained over the years at Teva api, and I’m so thankful for having all the opportunities to grow in to who I am now.

Megumi Saito spends her days in close contact with Teva api customers, supporting them and making sure they have everything they need — from technical information about a specific API to post-sales support.

I started off in the supply chain team which taught me a huge lesson in coping with intense and high-pressure situations!
In managing the local Japanese warehouse shipments, I was responsible for making sure that the last leg of the journey happened successfully – that customers received the final API product. I worked really hard on communicating effectively with each customer throughout every step of the process. Developing each relationship was key and in many cases, we became good friends.

After a year, I moved to the Customer Experience (CX) team. It’s really fun meeting the same customers again but from a different perspective.
I’m now involved with the customer from a much earlier stage of their journey. Before they make an order, I provide any information or samples they might need with regards to the DMF. After they’ve filed, I make sure they’re informed about any relevant updates and changes regarding product specifications or regulatory requirements. I take care of GMP inspections, complaints, arranging audits and more. It’s busy but I love it!

I used to export medical devices, now I import medicines.
I was always interested in the anatomy of the human body. I used to sell surgical microscopes for neurosurgery and plastic surgery, made in Japan, overseas. I had some pretty cool experiences – including seeing live heart and brain surgeries. It was shocking!

I’m not a chemist or a biologist but I love the medical field!
Every day I learn new things, which is why I love my job. Each interaction with a customer and our internal teams teaches me something new – about the formula of an API or a capability we can offer the customer. I’ve been opened up to a whole new world of science through my work in customer experience. It’s really fun. I think I’d be bored if I did the same thing every day.

My team has been my rock, especially during COVID-19.
When I first realized that the pandemic was going to affect everyone, including me, I was very concerned. I was nervous about working from home and how that would impact my role. Surprisingly, everything went smoothly and I didn’t have to worry at all. And I think it’s because of the level of trust between my team. I completely trust my colleagues and we all supported each other straight from the beginning. Even though we’re not working face to face at the moment, there’s this strong feeling that we’re there for each other and will help each other out, whenever needed.

My approach is to make each customer feel special and to give them an added value.
I don’t want to give my customers information that is already out there, but to give them a custom-made answer. So when they ask a question, I’ll always research the history with that customer – the interaction they’ve had with their account manager, or questions they’ve asked in the past, to provide them with an answer they’ll be extremely satisfied with.

I always try to analyze each problem from the customer’s perspective.
When there’s an issue, I’ll always ask myself, “if I was a customer, how would this make me feel?”, and then try to solve the query accordingly. And I see that customers really respond to this way of thinking. In one instance, after working with a customer over many months on a particular issue, we finally met and she said, ‘I can’t express my thanks to you enough.’ I remember feeling very chuffed that she felt so supported by me!

I always remind myself “When in Japan, do as the Japanese do”.
It’s very important for me to understand that there are differences not only in Japanese regulatory guidelines or pharmacopeia, but also in the culture, as well as perspectives from other regions in Japan. I believe the famous Japanese “wrapping culture” explains a lot. While I ask questions and get answers in very direct way with my global colleagues, I make sure to wrap my words with extra care and politeness when talking to local customers.

Teva api division is adding a new capability to its industry-leading products and services: API sterilization

We are expanding our basket of services, and we are pleased to share with you a new service of sterilization service through aseptic filtration.

You are now able to rely on Teva api’s vast expertise, state of the art facilities and latest best-in-class resources to address your product formulation needs and achieve your goals. Sterilization provides another valuable solution that may factor into your consideration set when selecting an API supplier.

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 product catalog
• API sterilization services 
• Teva api knowledge center – articles from experts on topics of API R&D, Supply, Regulation, Quality, and more.

Why lumping and flowability are an industry pain that is difficult to resolve… and why Teva api is determined to do something about it

Active Pharmaceutical Ingredients have several important physical powder properties including hygroscopicity, compactability, flowability and lumping.

Powders are complex materials… they could even be accused of having personalities…

• Not flowing
• Sticky
• Not loose
• Sensitive
• (Flowing) Not spontaneously

See how Teva api’s R&D experts can help you with flowability and lumping.

Several pharmaceutical processes including storage of powder, transportation, blending and compaction are influenced by powder behavior. Powder behavior issues such as flowability and lumping have been major challenges for the pharmaceutical industry, which works mainly with powders. These phenomena are complex, poorly understood and handled, and require prior experience and advanced analytical tools in order to be understood and resolved.

Flowability in Active Pharmaceutical Ingredients

Flowability – is the ability of powder to move in a specific system. The powders are lined up from “free flowing” powder to “non-flowing” powder.

Flowability of a powder refers to the specific relevant system. The same powder can flow with no issues in one system but will face difficulties in a different pharma equipment.

Flowability is a complex factor influenced by multi physical properties. Therefore the key to improve flowability will rarely be a small change in one production parameter and will not be characterized by a single analytical test.

Combinations of analytical tests (such as: angle of repose, compressibility index and Hausner ratio, flow through an orifice, shear cell methods) and deep evaluation of:

• Material features (electrostatic charge, cohesion and hygroscopicity)
• Production parameters (drying, milling processes)
• Environment conditions (humidity, moisture content and storage container)
• Pharma equipment that the powder should flow through

Will provide that starting point for improving the way the powder moves in pharma equipment.

The analytical tool can be useful in order to evaluate “better flowing” material, can distinguish between batches and allow you to have fine-tuning on your production parameters in order to comply with pharma requests and formulation instrumentation.

Lumping in Active Pharmaceutical Ingredients

Lumping can occur during storage: small aggregates accumulating over time within the powder, in extreme cases the entire powder takes on the shape of the container.

Lumping can also occur during drying: during solvent removal, lumps requiring “pre-milling” are created and in some specific cases, the lumps are too large to be milled by conventional means.

Lumps formation in the API is studied already in the early R&D stage. Several aspects of the Active Pharmaceutical Ingredient are considered in order to predict lumps formation: solubility, hygroscopicity, package information, particle size (milled, micronized) and solvents used in the last process step. Using multiple analytical tools such as microscopy, contact angle, PSD, lumping prediction in small scale, surface area, bulk and tapped density, angle of repose and more, Teva api is able to predict and control lumping in our APIs.

Lumping can be characterized by many analytical tools such as: microscopy and surface area (SSA)

Solving lumping issues, a case study

Tackles lumping is an Active Pharmaceutical Ingredient that has been produced by Teva api for more than 20 years and was known as lumped material. The solution to this lumping came from our customer’s formulation equipment that had separated all the lumps. A request from another customer raised the need of Teva api to evaluate the root cause and find a lasting solution to the phenomenon. One known technique to prevent lumps forming is to change the drying procedure. In this particular case, being the material highly hygroscopic, it was discovered that the discharge of the material from the drier needs to happen at a temperature very close to room temperature to prevent water absorption during cooling which could bring to the formation of water bridges.

After taking this precaution the lumping formation was reduced, but still some small lumps were observed in the material.

Further analyses led us to discover that residual solvent from the crystallization process can also contribute to the creation of lumps.

Residual solvent that was trapped in the wet part of the powder (part of the powder that was not well stirred or left in the corners of the dryer) was contributing to these smaller lumps. So additional drying was needed for that layer.

Another way to prevent lumping involves the packaging of the powders, this solution is recommended in cases of soluble material in water or in organic solvent.

All grades of particle size of this material had a tendency to lump over time. Extended drying and cooling prior to unloading solved the issue for the large and medium grades.

The fine grade material (micronized grade) would often lump even at the end of milling. Along with extended drying and cold unloading, packaging with N₂ has prevented lumping for at least 6 months after packing.

This complex problem is a challenge we accept on behalf of our customers

With our years of experience in the improvement of powder flowability and the prevention of lumping, Teva api is the industry leader. Teva api is constantly looking at new techniques, procedures and products that improve our customer’s end product experiences and their satisfaction with our Active Pharmaceutical Ingredients. By working in close cooperation with our customers we are ensuring that the properties of our powders match our customer’s expectation.

We would like to thank you for taking the time to visit our booth at FCE Pharma 2018.
We’ve prepered a short video to conclude the wonderful moments and memories from this years’ FCE.

This year our team focused on 2 main benefits of working with Teva api:

Teva api’s customer journey – It was a pleasure and honour to present Teva api’s Customer Journey and the different ways and tools Teva api offers along the product lifecycle to support our customers, this is a unique customer experience in the API industry, that provides support from the point of selecting an API supplier, through the development stages, Submission, Launch, and up to the commercial stage.

If you already have an on-going API project with Teva api, we also invite you to read more on our online customer platform – Teva api Online, customers are using the platform to create service requests, track progress of projects and download more than 5000 API documents – check it out now!

New pipeline products, technologies and services – it was a great opportunity to present our pipeline products for the LATAM market, discuss trends, new pharmaceutical technologies and services Teva api developed for its customers.

What is downstream processing (DSP) expertise?

Teva api’s downstream processing (DSP)

Teva api downstream processing (DSP) capabilities cover a broad range of products: from antibiotics, statins and immunosuppressant’s to high-potency compounds and enzymes. Our cutting-edge technologies, deep process understanding, and exceptional R&D services meet the most demanding industry standards.

Teva api owns large and modern downstream processing plants harmonized with our fermentation plants. They are highly automated and operated by skilled and experienced professionals who specialize in performing recovery processes required after fermentation.

Our R&D experts are involved in all stages of the product lifecycle to continually improve productivity and product quality for both new compounds and existing products.

Downstream Processing Activities

Our downstream processing activities cover diverse operations including whole broth extraction, vacuum-drum filtration, membrane filtration, evaporation, thin film evaporation, silica gel chromatography, ion-exchange chromatography, adsorption resin chromatography, crystallization, filtration, and drying. A DSP pilot plant and a DSP mini plant advance technology by delivering and implementing new processes across the facility.

Over the years, the Teva api downstream processing (DSP) team has conducted several technology transfer projects that have strengthened our QA, regulatory and other industry-leading competencies. Our R&D, engineering and production teams collaborate closely to ensure we consistently operate efficiently and effectively.

Teva api products, which involve the use of downstream processing expertise, are varied and include API products such as: Mitomycin, Tacrolimus, Caspofungin and more.