In this week’s news, the cell and gene therapy CDMO market is set to fluctuate and more.
CDMOs are continuing to invest in cell and gene therapy production capacity but demand is expected to fall in the next few years according to analysis by ISR.
The analysis – available here – is based on responses from 101 outsourcing decision-makers at biopharma companies who had responsibility for cell and or gene therapies within the past 18 months
At present 44% of developers outsource most or all of their activities to CDMOs. But, according to the report, the amount of work outsourced is expected to drop by half over the next five years as developers bring in-house capacity online.
However, while overall demand will fall, the number of CDMOs involved in each project is likely to increase as cell and gene therapies are launched in new markets.
“Once a therapy has been approved, there is a higher demand to manufacture the components which will potentially require more CDMOs to keep pace. This is especially true once a therapy is approved in more regions; finding a local provider becomes vital to production because cell & gene therapies are difficult to transport and do not have a long shelf life, often mere hours.”
At present drug makers use – on average – three CDMOs to meet their needs but this is expected to increase to four in the next five years.
Endpoints looked at the new US FDA guidance on benefit-risk principles in CMC assessments.
The New York Times reported that the COVID-19 vaccine manufacturing facility set up by Aspen Pharmacare has yet to receive a single order.
Problems at CDMO Emergent resulted in the destruction of 400 million doses of COVID-19 vaccine according to a report by the Wall Street Journal.
The Daily Herald reported that Baxter International plans to sell its R&D and manufacturing campus in Deerfield, Illinois.
The Pink Sheet looked at US FDA plans to simplify the terminology used for remote assessments of overseas manufacturing facilities making drugs and drug ingredients for the US market.
Bloomberg reported growing international concerns that missed COVID-19 vaccination targets may increase the risk of more viral variants.
Some developments of note in the contracting sector:
Bora Pharmaceuticals has acquired Eden Biologics’ CDMO assets i as part of its 5-year growth plan.
Avantor and Cytovance Biologics have entered into an agreement to manufacture research and GMP grade plasmids for biopharma customers.
Mayne Pharma Group has received grant under the Australian Government’s Modern Manufacturing Initiative (MMI).
Patheon, ThermoFisher’s CDMO unit, will make the API for NP001, a candidate ALS treatment being developed by Neuvivo.
Lonza will help portfolio companies owned by ALSA Ventures, a London based European investment firm, develop and manufacture biologics and small molecule drug candidates under a new agreement.
JSR Life Sciences says its new Similis Bio biologic manufacturing division will help biopharmaceutical companies improve the efficiency and cost of biosimilar development.
Lotte has announced plans to buy Bristol Myers Squibb’s manufacturing facility in East Syracuse, New York. The site will be base for the South Korean conglomerate’s new biologics CDMO.
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