Short timelines can be “one of the most critical decision for a lot of companies” when selecting a contract manufacturing organisation (CMO) to bring their biopharmaceutical to market, Thomas Jung, VP of Business Development at KBI Biopharma told delegates attending CPhI South Korea in Seoul Tuesday.
Speed in the preclinical and clinical stages brings innovative therapies to patients sooner and brings down the high cost of drug development, but has a further advantage for biosimilar developers, he said.
“There is very intense competition in the biosimilar market and an early entry is key in helping gain market share.”
For example, Remicade (infliximab) brings in roughly $9bn a year for J&J, but the commercial opportunity is falling as more players look to get a slice. Furthermore, some experts have predicted reduced development costs and growing market confidence is driving the biosimilar space to become over-crowded.
“Companies will look for any opportunity to shorten development time without sacrificing on quality,” Jung continued.
Streamlining methods
KBI Biopharma has therefore invested heavily to help expedite clients’ development timelines, he continued, across all stages of development and manufacture.
This includes using an Ambr 10L mini-bioreactor system for process development which Jung said the firm has been demonstrated reproducible to scales of up to 2,000L, reducing the conventional timeline from three to four months to less than 6 weeks.
The firm also uses single-use technologies in its approach to cGMP manufacturing, citing reduced timelines between batches due to the lack of CIP and SIP (cleaning in place and sterilization in place) processes, and has 200L and 2,000L Xcellerex bioreactors installed at its Durham, North Carolina manufacturing facility.
However, there are still times when a client demands specific timelines which the CMO can’t meet, Jung said, despite the continued investments across its biopharma services.