Contract manufacturers are a vital component of the biopharmaceutical ecosystem according to a new study which suggests the emergence of new therapeutic modalities will further cement this position.
The study – published in the latest edition of Frontiers in Bioengineering and Biotechnology – also identifies several “success factors” for contractors with use of advanced production technology, sufficient capacity and customer responsiveness being key.
According to the authors “ the horizontal division model in the pharmaceutical industry has become essential; biopharmaceutical companies focus more on drug discovery and development, while CDMOs focus more on process development and manufacture.
The also said it would be critical for CDMOs to invest more in technological development and acquire new technology to maintain a competitive edge.
“We believe that CDMOs will contribute significantly to a healthy life by continuous support to the biopharmaceutical industry in producing biopharmaceuticals for more diseases.”
Low volume, high-value drugs are a challenge for contract manufacturers according to experts who say production cost is the major hurdle.
According to a report by DCAT CDMOs are struggling with the pharmaceutical industry’s move towards orphan drugs – medicines for smaller patient populations – because the cost of producing them is too high.
One potential solution – according to the panel – would be to streamline material supply chains because the current model, under which CDMOs buy from multiple suppliers, is too complex and costly.
The experts also suggest that, to reduce production costs, contractors could maximize batch volumes at the early steps of the process and hold those as intermediates to build some economy of scale into the process.
Bioprocess Insider reported that Jubilant has entered into for a $149 million agreement with the US Government to double its injectable filling capacity at its Washington state plant.
The US FDA has resumed surprise CDMO and drug manufacturing facility inspections in India according to the PinkSheet. The report also states that plans to restart unannounced site visits in China have been delayed.
Pfizer plan to make its products available to 45 poor countries at not-for-profit cost according to a report by FiercePharma.
Contract Pharma quizzed August Bioservices’ Chief Commercial Officer, Joe Mase about trends to look out for in the CDMO sector for the rest of 2022. He predicted collaboration between drug firms and contractors will surge.
Some developments of note in the contracting sector:
South Korea based firm Hanmi Fine Chemical has set up an API CDMO.
Contract API manufacturer Olon plans to create an R&D hub at its headquarters in Milan, Italy,
Piramal Pharma Solutions says a new production line is operational at it manufacturing facility in Pithampur, Madhya Pradesh, India. Read the full report.
CDMO Lubrizol Life Science Health has launched Apisolex, a solubility-enhancing excipient for use in parenteral drug products.
ArchiMed and other investors have recapitalized Corealis Pharma. The plan is to further expand the CDMOs drug development services for and medium-sized biotech and pharma companies.
BOC Sciences has launched a new CDMO platform according to a press statement.
Clinigen Limited says it has nearly doubled capacity at its US site to better service large-scale clinical trials.
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