Growth Amid Risk
Interest in the biopharma industry continues to grow, making the development and manufacturing services of the biologic entities for both drug substance and drug product a more integral part of Patheon’s business. We have seen a demand — specifically from small to mid-sized companies — for contract development and manufacturing organizations (CDMOs) to enter the biotech business (including biosimilars) from development through manufacturing and commercialization.
However, moving into this industry comes with challenges. The biopharma industry is risky and expensive. For example, in the biosimilar world, the vast amount of data needed to compare these drugs with market-leading products makes the projects very costly. Additionally, many biotech products don’t transition into Phase 3 clinical trials, with many of them not even surviving past Phase 1 because of toxicity or lack of efficacy. Lastly, projects are often delayed by the complexity of active pharmaceutical ingredients (APIs). The complexity of biotech products makes them difficult to handle during the manufacturing process and the related analytical testing. Their management indeed requires a high level of expertise.
Looking Beyond Cost
Although the biopharma sector is strewn with roadblocks, highly reliable CDMOs are expanding as demand continues to increase. Clients are becoming more selective when deciding which CDMO to partner with to develop their product. While cost has always been an important factor when considering a CDMO, clients have recently shifted to a much broader examination, focusing on reliability as the most important element.
Additionally, as the product and the industry landscape are constantly changing, flexibility and the ability to troubleshoot become critical traits that clients seek in a CDMO. Flexibility of the project management team is vital to creating a successful client-CDMO relationship, while problem-solving skills are just as important since clients typically not only have products that need to be developed but also issues to be analyzed. Other key characteristics such as quality, expertise and end-to-end services are what make clients so willing to pursue and commit to fully integrated CDMOs like Patheon, which can offer both drug substance and drug product services.
Expertise On The Rise
Patheon is continuously proving itself as a leader in the CDMO industry, meeting clients’ expectations regarding quality, technical expertise, and end-to-end services and project management. A commitment to quality and customer service permeates every aspect of our business. Our clients demand reliability and transparency, and our Right First Time and On-Time Delivery philosophy is ingrained in our company culture. This system, which also enables clients to follow the entire development life cycle of their product, fosters personalized and long-lasting partnerships.
Additionally, the regulatory environment for both the sterile development and commercial manufacturing businesses continues to become more tightly monitored. With these strict regulations in place, there is a high expectation — particularly for complex biotech products — to have the product fully characterized and evaluated, specifically for critical process parameters (i.e., the evaluation of the robustness of the lyophilization cycle), so that it is guaranteed to be of high quality by the time it reaches the registration and validation stages.
Finally, the technological expertise expected of CDMOs is drastically increasing, and sites are becoming more automated as machines like automatic loading systems and restricted access barrier systems (RABS) are being used more and more at manufacturing facilities to maximize efficiency and increase the sterility assurance effectiveness.
A key differentiator for Patheon is its fully integrated offering, Patheon OneSource, an end-to-end solution focused on increasing simplicity, speed and quality by giving clients just one point-of-contact for all supply-chain services. Clients are becoming more and more interested in services such as this, as they drastically simplify the development process and supply chain.
To be valuable, a CDMO needs to be composed of the right people, the right processes and the right equipment, and if these important factors are not in place, target objectives cannot be met for clients and their patients.
The CDMO business serving the biopharma industry is changing quickly, and Patheon’s Ferentino, Italy, site is a prime example of it. Within just two years, we have doubled the size of projects, number of employees and clients served by the site, an indicator of how quickly things are changing within the market. Being a reliable provider of high-quality drug development and delivery solutions brings more clients to partner with to develop and launch their products.