At TAPI, scientific excellence is demonstrated through the way we design, optimize, and scale complex chemical processes. A newly published peer-reviewed paper from our R&D colleagues in Czechia, featured in Organic Process Research & Development (OPRD), highlights this approach through the development of a scalable synthetic route toward a key intermediate in Cantharidin. 

The publication showcases TAPI’s capabilities in advanced chemistry, crystallization development, and data-driven process optimization, applying Design of Experiments (DoE) and Quality-by-Design (QbD) principles to deliver a robust and industrially viable process. 

Why Cantharidin—and why now? 

Cantharidin is a highly potent natural terpenoid historically sourced from blister beetles. In recent years, interest in reliable synthetic manufacturing has grown—especially as pharmaceutical demand increases and supply chains seek reproducible quality, controlled impurities, and scalable production routes. 

In 2023, U.S. Food and Drug Administration announced approval of YCANTH (cantharidin) as the first treatment indicated for molluscum contagiosum, further reinforcing the need for robust manufacturing approaches to meet rising demand.  

What the paper demonstrates 

The team reports a lithium iodide (LiI)–mediated Diels–Alder cycloaddition that achieves: 

• High conversion efficiency under practical conditions 

• Excellent stereoselectivity (exo-selectivity)—reported as the highest to date in the paper’s context 

• Operational robustness, with conditions described as water- and air-tolerant 

• A process that was successfully scaled to the hundred-gram level using straightforward reactions and work-ups  

DoE-driven optimization to support QbD 

Rather than relying on one-factor-at-a-time optimization, the work applies a structured DoE approach to evaluate key parameters and interactions—supporting a QbD development mindset: 

• Identifying which factors most strongly influence conversion and process operability 

• Balancing conversion and selectivity with practical considerations like agitation parametersEnabling greater confidence in robustness and reproducibility when moving toward larger scale 

This is a strong example of how TAPI R&D brings data-driven process understanding into early development—setting the stage for smoother tech transfer and scale-up. 

A standout: crystallization-based isolation (no chromatography) 

One of the most practical highlights is the crystallization-based isolation protocol reported for the first time for this intermediate: 

• Enables isolation of a pure exo-isomer 

• Removes byproducts and residual salt without relying on chromatography 

• Provides a scalable approach aligned with industrial manufacturing expectations 

This crystallization strategy is a strong demonstration of our capabilities in solid-state understanding, isolation development, and impurity control—all essential for building scalable, manufacturable routes. 

Built with sustainability and cost efficiency in mind 

Beyond performance, the process development choices reflect modern process expectations: 

• Avoiding less desirable systems that require large excesses of certain salts 

• Using conditions designed for industrial operability 

• Introducing the possibility of recovering lithium iodide to improve overall cost efficiency 

This work reflects TAPI’s ability to translate deep scientific understanding into scalable, reproducible, and manufacturing-ready processes, supported by strong solid-state and crystallization expertise. 

Read the full article in Organic Process Research & Development to explore the complete methodology, data, and process insights. 
Scalable Synthesis of Cantharidin: Lithium Iodide as a Stereoselective and Efficient Catalyst in the Diels–Alder Reaction toward a Key Intermediate | Organic Process Research & Development

TAPI will only be able to offer and supply this pharmaceutical ingredient in the countries and exclusively for uses that are exempt from infringement of any exclusive rights(such as patents and/or supplementary protection certificates or extensions) in accordance with applicable law. TAPI requires adequate confirmation of the exempt use upon ordering. 

At TAPI, advancing health from the core means more than scientific excellence. It also means protecting people, preserving resources, and building a safer, more sustainable future across our global organization. 

That is the idea behind the first-ever TAPI EHS&S Awards 2025 — a new global initiative created to recognize exceptional contributions in Environment, Health, Safety and Sustainability across TAPI. 

Launched in mid-October 2025 and highlighted during TAPI EHS&S Week in November, the awards were created to celebrate individuals and teams whose work goes beyond compliance and creates real, lasting impact. Whether through innovation, leadership, collaboration, or continuous improvement, these are the people helping strengthen TAPI every day. 

The program also reflects TAPI’s principles in action: A community more than a company, We love to win, Beyond is where we begin, and We crave science and technology. 

Why These Awards Matter 

In their first year, the EHS&S Awards drew 43 applications from across TAPI in categories including Environment & Sustainability, Safety, Health, Culture, and Other. 

Each submission was reviewed by the Global EHS&S team based on clear criteria: 

• Innovation and originality 

• Magnitude of impact 

• Sustainability and long-term applicability 

• Measurable results and quality of data 

• Replicability across sites 

Following the review process and alignment with top management, four winning projects were selected and announced during the TAPI Q4 and FY2025 Town Hall on January 29, 2026. 

Together, the winners show what EHS&S excellence looks like at TAPI today: practical, people-centered, measurable, and forward-looking. 

Netanel Hakimi 

“Community more than company – doing it together” 

TAPI Israel, Abic 

As TAPI continued strengthening its independent EHS&S practices, the Abic site identified a need for a simple and effective way to report safety observations, hazards, and near misses in its dynamic R&D environment.

The answer was GOARC, a digital safety platform installed on employees’ phones, enabling real-time reporting and immediate follow-up. With strong training, communication, and leadership support, the tool quickly became part of daily work. 

Since launch on July 1, 2025, the site has recorded more than 100 hazard reports and over 50 observation reports, with a closure rate above 90%. Just as importantly, the initiative has helped strengthen trust, accountability, and collaboration across departments. 

This project stood out for turning safety reporting into a shared cultural practice — making prevention more visible, more accessible, and more effective. 

Engineering and Energy Utilities Team 

“Utilization of Waste Heat from WWTP Blowers” 

TAPI Czech Republic, Opava 

Pavel Stehlik’s team focused on finding a smarter use for energy already being generated on site. 

At the Opava wastewater treatment plant, heat produced during air compression for biological aeration was being wasted. The team identified an opportunity to capture that heat and redirect it to the neighboring main warehouse building. 

After system design, cost assessment, and equipment installation, the project delivered clear and measurable results. In its first year, it saved 714 GJ of heat and reduced natural gas consumption by 19,000 m³, generating approximately USD 17,400 in heating energy savings. 

The environmental impact was just as significant, with a reduction of 40 tons of CO2 emissions and additional savings linked to avoided emission allowance costs. 

This project is a strong example of how practical engineering can create value on multiple levels — reducing emissions, lowering costs, and improving energy efficiency at the same time. 

Anantha Rajmohan M 

“Smart Science for a Safer Tomorrow: AI and Automation Elevating EHSS Standards in Polymorph search ” 

TAPI India R&D, Greater Noida 

In TAPI’s polymorph search activities, Anantha Rajmohan M and the Greater Noida team rethought traditional workflows through the lens of EHS&S, combining AI, automation, advanced equipment, and improved engineering controls. 

Polymorph screening is strategically important, but it can also be resource-intensive. The team introduced a smarter model that reduced solvent handling, minimized exposure to hazardous chemicals, lowered waste generation, and improved ergonomics for scientists. 

Among the key improvements, solvent storage was significantly reduced, experiment scale was lowered, and advanced systems such as Genevac, Polar Bear, and high-throughput screening tools enabled more efficient, lower-waste experimentation. AI-driven calculation tools also helped reduce zero-yield experiments from 35–40% to around 10%, generating up to 25% savings in API use, solvent consumption, and man-hours. 

Beyond operational efficiency, the shift also reduced repetitive manual work and physical strain, allowing scientists to focus more on planning, analysis, and innovation. 

This project stood out for showing how science and technology can directly improve safety, sustainability, and research quality — all at the same time. 

Teva Tech Team 

“From Risk to Resilience – Setting a New Benchmark for Managing Acutely Toxic Chemicals” 

TAPI Israel, Teva Tech 

The Teva Tech Team project addressed a major safety challenge: managing acutely toxic non-API chemicals in the absence of formal best-practice standards. 

At Teva Tech, the team identified a gap in how substances with severe acute toxicity — such as Hydrazine Hydrate, DIC, and TBHP — were managed across their lifecycle. In response, they developed a comprehensive risk management strategy that created a new benchmark for safe handling. 

The project introduced improvements across storage, transport, transfer, sampling, emissions treatment, and disposal. These included minimizing packaging sizes, defining dedicated storage requirements, eliminating unnecessary sampling, implementing strict transportation guidelines, and establishing closed transfer systems with leak-tight engineering controls and early leak detection. 

The result was a significant reduction in exposure risk, improved industrial hygiene and process safety, and stronger control over hazardous emissions and waste. 

This project stood out because it did not simply improve an existing framework — it created one. It is a clear example of proactive safety leadership in action. 

Building a Stronger TAPI, Together 

The first TAPI EHS&S Awards highlight the depth of talent, commitment, and innovation across our global network. 

From strengthening reporting culture in Israel, to recovering energy in the Czech Republic, to transforming laboratory workflows in India, to setting new standards for chemical safety in Israel, each winning project reflects a different side of what responsible progress looks like at TAPI. 

Together, they show that EHS&S excellence is not only about reducing risk. It is about enabling innovation, supporting resilience, and reinforcing the culture that helps TAPI move forward — safely, responsibly, and sustainably. 

As the pharmaceutical industry continues to evolve, partnerships that bring together innovation, experience, and the ability to scale are becoming increasingly important. The collaboration between TAPI and Antheia reflects this shift, combining complementary strengths to help advance critical pharmaceutical ingredients toward reliable commercial supply.

In a recent joint interview, R. Ananth, CEO of TAPI, and Zack McGahey, COO of Antheia, share their perspectives on what makes this partnership meaningful, the realities of moving from development to larger-scale execution, and the broader importance of alignment, agility, and long-term thinking in today’s industry landscape.

Their conversation offers a closer look at how strong partnerships can help connect innovation with execution, and why that connection matters more than ever as the industry works to build more resilient and future-ready supply models.

R. Ananth, CEO of TAPI: “What motivates us is the opportunity to collaborate with partners like Antheia earlier and more closely, applying our development expertise, regulatory knowledge, and global infrastructure in a way that truly supports their long-term growth.”

Read the full interview here: https://bit.ly/4rRlBuC

When global demand for GLP-1–based therapeutics surged, our teams at TAPI faced an urgent challenge: to design and scale up a complex peptide process — from development through GMP manufacturing — faster than ever before. 

The result was a remarkable achievement: a state-of-the-art, fully automated production system built and qualified in record time, enabling delivery of high-quality material to meet global needs. But beyond the technical accomplishment lies a deeper story — one that reflects how TAPI operates as a CDMO partner: with agility, scientific depth, and an unwavering focus on collaboration. 

One Team, One Purpose 

From day one, our R&D and Operations teams worked as a single project unit, side by side on the shopfloor, united around one goal — bringing a new peptide to life for our customer. 

This integrated approach lies at the core of how we operate as a CDMO: by aligning science with execution, we ensure seamless tech transfer, accelerated timelines, and right-first-time delivery. 

Fast Response, Proven Expertise 

Introducing a new peptide product under extremely tight timelines required exceptional coordination and technical mastery. 

Leveraging decades of peptide experience and advanced process know-how, our cross-functional teams developed and scaled the process with speed, precision, and flexibility — repurposing equipment, optimizing systems, and implementing advanced analytical tools, all while maintaining full GMP compliance. 

The result: a fully qualified production system and a successful first GMP batch delivered on schedule — proving that agility and reliability can coexist, even in the most complex projects. 

Since then, the system has supported dozens of peptide batches — both for this product and additional molecules — demonstrating its robustness, scalability, and repeatability. 

Built for Flexibility and Performance 

Every element of the system was engineered with operational flexibility in mind. 
From in-house-developed purification systems to continuous concentration technology and solvent-recovery loops, innovation guided every decision. 

Operators were trained to perform real-time in-process controls (IPC) using HPLC and UPLC directly on the production line — increasing efficiency, reducing cycle time, and improving yield. 

Advanced Process Analytical Technology (PAT) and automation enable real-time process adjustments, ensuring consistent quality and minimizing variability. 
Today, our peptide production spans an impressive range — from below 5 all the way to tens of amino acids, across facilities capable of handling scales from a few kilograms up to 1.5-ton batches. 

These same technologies now underpin CDMO projects across multiple modalities at TAPI — from small molecules and peptides to HPAPIs and oligonucleotides. 

Innovation with Purpose: Sustainable by Design 

Sustainability guided this project from the start. 
The system integrates solvent recovery and recycling, energy-efficient emission treatment via RTO technology, and zero-discharge wastewater management — ensuring environmental responsibility without compromising performance. 

By combining process innovation with responsible manufacturing, TAPI continues to advance greener chemistry and help customers achieve their ESG goals. 

Partnership in Action 

This achievement embodies what TAPI brings to every CDMO collaboration: 

• One integrated team — R&D and Operations working as one. 

• Agility and speed — rapidly adapting to business needs and market timelines. 

• Operational flexibility — customizing systems and processes for each molecule. 

• Technical excellence — leveraging automation, PAT, and computational tools. 

• Sustainability commitment — embedding ESG values in every project. 

Through science, teamwork, and relentless drive, we turned a bold idea into a working reality — delivering value where it matters most: to our customers. 

Ready to Accelerate Your Program? 

At TAPI, we combine deep scientific expertise with global operational strength to help CDMO partners bring their molecules from concept to commercial reality — efficiently, safely, and sustainably. 

Learn more about our CDMO capabilities or reach out to our team to discuss your next project. 

Peptide-based therapeutics, especially GLP-1 agonists, have become essential tools in treating chronic diseases like type 2 diabetes and obesity. But behind their clinical promise lies a manufacturing challenge since peptide production is complex, sensitive to scale, and often resource-intensive. 

At TAPI, we’ve turned this into an opportunity. 

By embedding Process Analytical Technology (PAT) into every step of the peptide manufacturing process, we’ve developed a smarter and greener platform—already implemented at GMP scale—that elevates process control, accelerates timelines, and reduces environmental footprint. 

This innovation is a model for how we support CDMO partners with demanding peptide programs. 

A Holistic, Data-Driven Approach 

Peptide manufacturing is inherently intricate, with limited in-process monitoring options and high sensitivity to deviations. Our cross-functional R&D and engineering teams tackled these challenges head-on by implementing a comprehensive PAT framework across synthesis, purification, concentration, and lyophilization. 

Application of such real-time PAT tools include: 

1. Refractive Index (RI) and ultraviolet spectroscopy (UV) monitoring in Solid Phase Peptide Synthesis (SPPS): Used during coupling and deprotection, RI detects deviations in reaction completeness or reagent flow, while UV confirms Fmoc removal via characteristic absorbance. Together, they provide real-time insight into reaction progress and enable early intervention, improving sequence integrity. 

2. Conductivity monitoring in wash steps: In-line conductivity sensors measure residues and by products species such as dibenzylfulvene (DBF) and piperidine during resin washing, allowing dynamic wash control based on predefined thresholds. This eliminates unnecessary solvent use and enables DMF recirculation without compromising quality. 

3. Near-Infrared (NIR) spectroscopy for piperidine residue monitoring: NIR enables in-line quantification of residual piperidine, ensuring effective washing before each coupling step. This improves process readiness while reducing DMF use. 

4. Conductivity and NIR in downstream purification: Conductivity monitoring controls buffer preparation via in-line dilution and defines wash endpoints during desalting and ion-exchange. NIR enhances robustness, and in some cases serves as a real-time control for acetonitrile gradient accuracy in HPLC. 

5. UV monitoring in continuous concentration on a Wiped Film Evaporator (WFE): UV-based PAT tracks peptide concentration during evaporation using WFE (wiped film evaporation). Initially applied as at-line IPC, this was upgraded to in-line UV, achieving concentrations up to 100 mg/mL for GLP-1 peptide. This enabled efficient lyophilization while maintaining product homogeneity. 

6. Pressure monitoring in lyophilization. Dual pressure sensors (Pirani and Barocel) define robust drying endpoints independent of scale or load. This prevents overdrying, which was previously linked to peptide aggregation, ensuring product stability and process consistency. 

The result? Shorter cycle times, enhanced robustness, and right-first-time production—crucial benefits in a field where variability has long been the norm. 

Proven at Scale, Ready for Partnership 

This isn’t a lab-scale concept. Our PAT-enabled platform is fully operational in GMP manufacturing and has already demonstrated a measurable impact: 

• Reduced solvent and energy use 

• Minimized human error through real-time monitoring 

• Enhanced product consistency across batches and scales 

• A digital foundation for future AI and machine-learning integration 

Whether you’re looking to de-risk development, scale a late-phase peptide, or secure long-term commercial supply—TAPI brings proven capabilities, advanced infrastructure, and CDMO flexibility to the table. 

The TAPI Advantage for Complex Peptides 

With decades of peptide experience, dual-site GMP capacity in Israel and Croatia, and modular technologies (SPPS, LPPS, hybrid), TAPI is uniquely equipped to support partners from early development to commercial launch. 

As a CDMO, we don’t just offer capacity, we offer chemistry innovation, analytical depth, and strategic thinking. Our teams understand the nuances of peptides and work with you to design scalable, sustainable processes that meet your molecule’s specific needs. 

Partner with TAPI for Your Peptide CDMO Needs 

From GLP-1 agonists to custom sequences, we’re redefining what’s possible in peptide manufacturing. If you’re seeking a partner who blends cutting-edge technology with reliable execution, let’s talk. 

Contact us to explore how TAPI can support your next peptide program. 

At TAPI, advancing health from the core also means protecting the environment at the core of everything we do. Across our Teva Tech site, we’ve launched a bold initiative to transform sustainability from a checklist into a culture, embedding greener practices into every aspect of manufacturing. 

From Program to Culture 

In the past, sustainability lived mainly in the domain of EHS&S. Today, it’s a cross-departmental mission, driven by a dedicated site-wide sustainability team. By bringing together expertise from engineering, operations, production, and beyond, we’ve sparked new levels of engagement, creativity, and ownership. Every employee has the opportunity to contribute—and every idea matters. 

The goal? To be sustainable in sustainability—making continuous improvement an everyday mindset. 

Innovation Meets Responsibility 

Our cross-functional approach has already led to tangible improvements: 

• Energy efficiency: Installing variable frequency drives (VFDs), optimizing compressors, and upgrading chillers. 

• Leak detection with next-gen tools: Using thermal, 360°, and sound cameras to spot and eliminate hidden leaks in nitrogen, air, and steam systems. 

• Green electricity: Since April 2024, Teva Tech has been powered exclusively by renewable energy, with IREC certification in progress. 

• Zero-liquid discharge mindset: Real-time monitoring of emissions, advanced wastewater treatment, and solvent recovery built into every new product. 

• Paperless production: Piloting electronic batch records to eliminate paper use and streamline compliance. 

• Smarter waste management: Campaigns for separation and recycling of plastics, metals, batteries, and more. 

These projects are designed not only to reduce energy, water, nitrogen, and steam consumption by 5–15% per year, but also to ensure measurable reductions in Scope 1 & 2 GHG emissions. 

A Win for Customers and Communities 

For our customers, sustainability is a shared priority. By reducing GHG emissions in all our sites in TAPI, we are helping our partners to achieve their ESG targets. At the same time, our initiatives strengthen supply reliability, reduce costs, and ensure compliance with local and global regulations. Beyond numbers, this program is shaping how our people think, act, and innovate. Every new project now runs through the lens of sustainability, making greener operations our standard way of working. 

Looking Ahead 

We see this as just the beginning. From exploring on-site energy storage to scaling AI-enabled monitoring systems, the journey to a greener future is ongoing. Most importantly, sustainability at TAPI is no longer just a department, it’s a shared responsibility and a source of pride. 

As a provider, partner, and pioneer, we are setting a new benchmark for green API manufacturing — one that benefits our industry, our customers, and the communities we live in. 

In pharmaceutical development, the race to bring medicines to patients faster—without compromising on quality—is more critical than ever. At TAPI, we’re answering that challenge head-on with an innovative platform that transforms how solid forms are identified and developed. By integrating computational tools with high-throughput laboratory automation, we’re not just streamlining solid-state R&D—we’re reshaping it. 

Rethinking Polymorph Screening 

Solid form matters. Polymorphs, hydrates, solvates, and amorphous structures may influence a drug’s solubility, stability, manufacturability, and regulatory path. Traditionally, uncovering these forms has relied on labor-intensive, trial-and-error methods. Our bespoke platform reimagines this process by combining computational tools modeling with smart experimental design. 

We leverage tools like Crystal Structure Prediction (CSP), lattice energy ranking, and targeted screening algorithms to identify different solid forms. Our unique approach allows us to creatively design the experimental plan before we even step into the lab—saving time, materials, and energy. 

From Prediction to Precision: Smart Experimentation in Action 

Our software-based systems are fully integrated with  automated high-throughput polymorph screening (HTPS). This means that parallel experimentation with multiple crystallization conditions can be conducted faster and more systematically than ever before. Using tools like PXRD, DSC, TGA, and microscopy, we can rapidly identify and characterize different solid forms with scientific rigor. 

And thanks to a closed-loop feedback system, experimental data feeds back into the AI models—making them smarter over time and improving accuracy with every iteration. 

Impact That Scales 

This is more than a lab breakthrough—it’s a platform with real-world impact. By enabling earlier identification of optimal solid forms, we help pharmaceutical partners minimize late-stage surprises, improve formulation robustness, and accelerate regulatory submission. It’s a smarter, safer, and faster way to advance drug development. 

A New Standard for Solid-State Innovation 

At TAPI, science is strength—and our innovative platform embodies our passion for advancing health from the core. By combining digital intelligence with expert intuition, we’re enabling our partners to make better decisions, faster. It’s not just innovation—it’s transformation. 

Whether you’re formulating a first-in-class therapy or optimizing a generic molecule, our AI-powered solid form platform is ready to support your journey. 

Let’s move beyond what’s expected. Let’s redefine what’s possible. 

At TAPI, we are dedicated to advancing sustainable pharmaceutical manufacturing by harnessing the power of cutting-edge science—particularly biocatalysis. One of our recent successes exemplifies this commitment: the development of a scalable, environmentally responsible biocatalytic process for the production of a complex chiral intermediate used in the synthesis of Avacopan. This achievement not only overcomes long-standing challenges in stereoselective synthesis; it also demonstrates the broader potential of enzyme-based technologies to streamline pharmaceutical production. 

By integrating biocatalysis into our development workflows, we offer innovative, greener alternatives to traditional chemical routes—delivering benefits in efficiency, selectivity, and sustainability. These capabilities are now a core part of our value proposition, both for our internal portfolio and for partners through our CDMO services. Whether optimizing existing processes or designing new synthetic pathways, we are helping to redefine what’s possible in pharmaceutical manufacturing through biocatalytic innovation. 

The Challenge: Double Stereocontrol with High Yield and Low Waste 

The synthesis of 2,3-disubstituted cyclic amines — especially with full control over two adjacent stereocenters — has historically been a significant challenge in API development. Traditional chemical synthesis routes for Avacopan’s (2R,3S)-2-arylpiperidine-3-carboxylate intermediate rely on diastereomeric crystallization, a process that discards nearly half of the material and yields only 42%. 

We saw an opportunity to develop a cleaner, more efficient alternative. Inspired by the principles of green chemistry, our team sought a stereoselective, biocatalytic solution that could reduce waste and improve scalability. 

The Solution: Enzyme-Catalyzed Amine-Imine Transformations 

Through extensive enzyme screening, we developed two innovative routes using imine reductases (IREDs): 

1. Oxidative kinetic resolution of the racemic amine, followed by catalytic hydrogenation for enantiomer recovery — successfully scaled up to kg scale. 

2. Dynamic kinetic reduction using enantiocomplementary IREDs — demonstrated at lab scale, showing strong potential for further development.

These pathways hinge on the reversible imine-enamine tautomeric equilibrium, which allows for efficient recycling of undesired stereoisomers and high selectivity toward the desired (2R,3S)-configured intermediate. 

Key Innovations 

• Enzyme Selection and Cofactor Regeneration 

We identified four commercial IREDs capable of enantioselective oxidation and two others for dynamic kinetic reduction. However, to make the process robust and scalable, we also needed an efficient system for cofactor regeneration. 

Traditionally, NADPH oxidases (NOx) were used for this role but posed challenges due to their sensitivity to solvents. Our breakthrough came with the application of alcohol dehydrogenase (ADH) enzymes — specifically from Lactobacillus brevis — as a more stable and scalable alternative for cofactor regeneration. This was the first reported use of ADHs in IRED-catalyzed oxidations, marking a significant step forward in biocatalysis. 

• High Selectivity and Improved Yields

Our enzymatic process achieved exceptional selectivity: 

• Oxidative route: >99.5% ee and >99.9% de 

• Reductive route: 98.3% ee and >99.9% de 

The oxidative route also significantly improved overall yield. By coupling it with a catalytic hydrogenation recovery step, we reached 72% yield across cycles — a dramatic improvement over the 42% achieved by conventional crystallization. 

• Scalable, Safe, and Sustainable 

Safety and scalability were paramount. Unlike earlier methods using monoamine oxidases and hazardous reducing agents (like boranes), our enzymatic routes avoid incompatible chemicals. The oxidation process was safely scaled to kg levels, with a high space-time yield of 37.2 g/L/day — a strong metric for industrial viability. 

In terms of sustainability, the use of biodegradable enzymes, mild conditions, and minimized waste supports our commitment to environmentally responsible API production. 

A Model for Future Development 

Our biocatalytic model provides a practical framework for innovation in pharmaceutical manufacturing, tackling issues that rise from a standard chemical synthesis approach: 

• It illustrates how the stereo controlled synthesis of complex amines can be achieved efficiently using green chemistry, addressing a long-standing synthetic challenge. 

• It expands the perceived role of ADHs by demonstrating their effectiveness in oxidation reactions, opening new avenues within biocatalysis. 

• It highlights how enzyme-driven processes can achieve both economic scalability and environmental responsibility—two critical priorities for the industry. 

Partnering for Innovation: CDMO Services at TAPI 

This breakthrough in the synthesis of Avacopan API exemplifies how targeted innovation, grounded in green chemistry principles, can transform pharmaceutical manufacturing. With better yields, reduced environmental impact, and strong scalability, this process is not just a milestone for TAPI — it’s a glimpse into the future of sustainable use of biocatalysis in pharmaceutical manufacturing. 
 
This achievement reflects more than scientific innovation—it demonstrates what’s possible when advanced technologies meet end-to-end CDMO support. At TAPI, we offer integrated CDMO services across every stage of development, from route scouting and process design to scale-up, GMP production, and commercial supply.  

Our global network spans 13 manufacturing sites and 5 R&D centers, supported by ~450 scientists and a deep toolbox of enabling technologies—from biocatalysis and flow chemistry to particle engineering and ultrafiltration. Whether your program involves small molecules, peptides, oligonucleotides, fermentation products, or HPAPIs, we’re ready to tailor solutions that accelerate your success. 

Fermentation is at the heart of many life-saving medicines. But when it comes to large-scale production, it’s one of the most unpredictable and complex processes in pharmaceutical manufacturing. At TAPI, we’ve taken a bold step toward solving this challenge—by combining data science, automation, and our deep process expertise to revolutionize how we manage substrate feeding in fermentation. 

The Challenge: Complexity in Every Drop 

As a global leader in active pharmaceutical ingredient (API) production, TAPI has a long-standing tradition of excellence in fermentation. Our largest fermentation site, based in Hungary, handles some of the most technically demanding production processes. These processes involve living organisms, over 200 hours of process time, and highly sensitive multi-variable conditions—all of which can lead to unpredictable yields and inefficiencies. 

One of the biggest variables? Substrate concentration. It needs to be maintained within an extremely narrow range throughout the entire process, which is no easy task with such complexity in play. 

The Solution: Smarter, Safer, and More Sustainable 

To meet this challenge head-on, we partnered with a specialist in process control to develop and implement an automated substrate feeding strategy. The result: a cutting-edge system powered by big data analytics, real-time prediction (via a “soft sensor”), and continuous concentration control. 

Key highlights include: 

• Real-time control: The system calculates and adjusts the substrate dosage rate automatically, removing the need for manual sampling and reactive adjustments. 

• AI-driven prediction: A soft sensor uses production data to predict substrate levels, enabling proactive decision-making. 

• Seamless integration: The algorithm was designed to fit into existing systems without disrupting ongoing operations. 

This wasn’t just a theoretical exercise—the system is live and delivering results. 

The Impact: Greater Efficiency, Lower Carbon Footprint 

Since implementing this control strategy, we’ve seen over a 15% increase in productivity, while simultaneously reducing our carbon footprint. By keeping substrate levels consistently optimal, the system minimizes fluctuations and improves reproducibility—two major pain points in any fermentation process. 

And the best part? This approach is scalable. The same control model can be tailored and applied to other fermentation processes across our sites, unlocking even broader improvements. 

Looking Ahead: A New Standard in Bioprocess Control 

What sets this development apart is not only the technology—but the mindset behind it. We’ve shown that internal know-how, combined with external collaboration and smart data use, can lead to real operational transformation. With this innovation, TAPI is setting a new benchmark for how fermentation can be controlled: more precise, more consistent, and more sustainable. 

This is just one example of how we’re advancing health from the core—by optimizing the very processes that make modern medicine possible.