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4 BioPharm International eBook February 2020 www.biopharminternational.com Manufacturing at Lonza, agrees. "The biotechnology sector is pro- jected to grow faster than the con- ventional pharma sector (9% vs. 6% CAGR [compound annual growth rate] 2019–2024). The strong ven- ture capital funding for biotech companies will continue to support a healthy growth that positively impacts the outsourcing sector." Glo b a l D at a's r e p or t, "G e ne Therapy Market Opportunity for CMOs–2019 Edition", shows an investment by CDMOs in greater capacity for anticipated gene ther- apy pip e l i ne pro duc t s, e it he r through acquisitions or building facilities (2). "Some pharma com- panies including Pfizer and blue- bird bio are also investing in gene therapy manufacturing facilities for excess capacity contracts or for in-house manufacturing of propri- etary therapies. Cobra Biologics Ltd, Symbiosis Pharmaceutical Services Ltd, Novasep, LakePharma, Oxford BioMedica Plc, and Sanofi have also made recent major investments in gene therapy manufacturing, especially in viral vector manufac- turing for gene transfection," says Fiona Barry, editor, PharmSource, a GlobalData product. According to Eric Langer, presi- dent of BioPlan Associates, CDMOs offer expertise, cell and gene ther- apy processes, personnel, and capac- ity that pharmaceutical companies may not have. "In our research on the make-vs-buy decision process, we have found that many compa- nies decide early in their develop- ment that they intend to become a fully integrated bio/pharma com- pany, including seeing manufactur- ing as a core competency. Others see manufacturing as potentially outsource-able and not part of their core competency. Still others need the flexibility to decide their man- ufacturing strategy as their pipeline develops and as their investment situation unfolds. Nearly a third of biologics are produced using CMOs [contract manufacturing organiza- tions] and CDMOs, and these orga- nizations are now an integral and indispensable part of the industry," says Langer. A LOOK AT THE CDMO MARKET IN 2020 How has the push toward biologics changed or added to the processes pharmaceutical companies are out- sourcing and CDMOs and CMOs are offering? According to Bernie Clark, vice-president, Marketing and Strategy, at Catalent Biologics, the contract industry will continue to evolve to meet the needs of the developing biologics market and to support the trend of personalized medicine. " N e x t- ge ne r at io n b iolo g ic s , such as ADCs [antibody-drug con- jugates], bi-/multi-specifics, gene t herapy, a nd cel l t herapy, a re growing sectors of the biologics industry, and providers are adding capabilities to support the unique needs of these novel modalities. For example, new analytical tech- niques a re being developed to support these new therapies, and providers are evaluating whether it makes sense to adopt them as part of their offerings. Other capa- bilities being evaluated include potential process improvements, such as continuous manufacturing and automation, and providers are conducting cost-benefit analyses for adopting these technologies into their platforms. One driver to adopt continuous manufacturing, but also a more general industry trend, is the shift toward biolog- ics that treat smaller patient pop- ulations, such as therapies that address orphan indications. This shift has resulted in a movement towards manufact uring smaller batch sizes, which has led to more investment in smaller bioreactors, w ith a heav y emphasis on sin- gle-use technology," says Clark. C at a le nt h a s b e e n e v a lu at- i ng p ossible new c apabi l it ie s, says Clark, and acquired Paragon Bioservices as part of their expan- sion into the gene therapy mar- ket. "On the technology front, we adopted the Beacon system from Berkeley Lights to expedite clonal selection and improve titers for monoclona l a nt ibod ies a nd Fc fusion proteins. However, it is not enough to just acquire the right equipment or technology; contract organizations also need experts who are knowledgeable and expe- rienced in the challenges that need to be addressed. We are focused not only on adopting new technol- ogies for our customers but also on hiring or building the right exper- tise to support them across our global network," says Clark. "Cell and gene therapy manu- facturing is, of course, relatively new to the biopharma industry, and these will be seeing signifi- cant increases, especially as the cell and gene therapy innovators move their pipeline toward com- mercialization. As demand for clin- ical capacity increases, there will be a potential capacity crunch for CDMOs capable of meeting these needs. But doing so will require having the skilled staff capable of work in this segment. And hir- ing of these experts is becoming increasingly challeng ing," says Langer. According to Langer, the next two years will see more analytical testing being outsourced. "From our annual report (3), we find that analytical testing, including bio- assays, leads the list with 32.8% indicating they will be doing more. Follow ing is cell line develop - ment (24.1%) and cell and gene therapy production (23.4%). Fill/ Partnerships for Outsourcing Cover Story