Over the years, pharma and biopharma companies have increasingly relied on contract service providers to help address increased development and manufacturing complexity, and quality and safety requirements that demand skilled and flexible services. Complexities related to formulation and delivery, and manufacturing and cold chain management of highly-potent drug products and biologics, have all led to more integrated outsourcing across the continuum, from drug discovery and development through to manufacturing and packaging. David Enloe, President and Chief Executive Officer of Ajinomoto Bio-Pharma Services shares his perspective on market changes over the years and the evolution of more integrated outsourcing. –KB
 
Contract Pharma: What were some of the major pharma/biopharma industry changes in the past 20 years that have greatly impacted contract service providers? 
 
David Enloe: Over the past 20 years, we have seen a lot of changes for pharma/biopharma and CDMO industries. For example, big pharma has slowly been moving away from manufacturing drugs in-house, leading to increased outsourcing for all stages of clinical and commercial manufacturing. We have also seen more virtual and small/mid-sized biopharma companies enter the market. These smaller companies have focused more on orphan, as well as more potent and targeted drugs, and therefore lower volume drugs. This has created the need for CDMOs to be more adaptive and responsive to different client needs. Along these lines, we have seen an increased number of FDA approvals and clinical pipeline growth. Finally, we have seen a shifting mindset between quality and price, with movement from US and EU suppliers to India and China, and then back again, with security of supply, environmental awareness and protection, and corporate social responsibility playing a role in this shift.
 
CP: What are some changes you anticipate for the future of the industry and outsourcing?
 
DE: Going forward, we expect to see the biopharma industry to maintain focus on targeted, potent, and orphan drug development. For CDMOs, we expect to see continued supply chain consolidation, with CDMOs offering services from preclinical development to fill/finish and packaging, as well as, investment in technologies that reduce the impact on our environment.
 
CP: How have service offerings and operations for CDMOs evolved over the years?
 
DE: Technological advancements in formulation development, in manufacturing process, and development of new methods from “old” processes, have helped the CDMO industry evolve. The technologies we now use for development work, were not around 20, even 15 years ago. The advancements are in pace with the changes in biopharma clients’ needs, providing a competitive edge in manufacturing costs as they shift towards fewer chemical processes and more biologics, potent and targeted and orphan drugs, as well as.
 
CP: What global market changes have had the greatest impact on the industry and CDMO services? 
 
DE: With customers looking for integrated end-to-end services, we have seen big pharma companies simplifying their supply chain and reducing the number of CDMOs that they work with. This has led to a large consolidation of the CMO, CDO, and CDMO space. A few years ago there were several CMOs / CDOs / Fill Finish providers that offered selective services and capabilities. Whereas today, we see large CDMOs fulfilling every need a customer could have.
 
The focus on reducing waste and protecting the environment, has played a big part in changing the industry, especially in manufacturing. We are now using more continuous and automated processing lines, and incorporating green chemistry into development and manufacturing processes.
 
CP: What are some of the major regulatory changes that have impacted the industry?  
 
DE: On the regulatory side, we have seen some major changes over the past 20 years that have not only advanced the industry, but also our regulatory program. Regulatory fillings require higher quality, more data and are undergoing more scrutiny, in addition to requiring electronic filing. We have also seen more robust validation requirements (especially for process validation, continuous process validation, computer system validation, and QC method validation), stronger aseptic requirements (better best practices, thorough media simulations, and preference for isolator technology), and increased regulation of combination products, such as prefilled syringes. We continue and expect to see a strong focus on data integrity management and risk management systems, including risk assessments and escalation as the regulatory industry continues to advance practices and governance.
 

 David Enloe