In this week’s news, mega CDMOs impacting M&A, FDA calls on help for blockchain T&T tech, gene therapy costs a headache for regulators and more…
Mega CDMOs changing industry M&A activity
Drug industry dynamics are reshaping the CDMO sector according to a report by DCAT.
The report says the emergence of mega CDMOs supports the idea of growing pharma industry demand for contractors that offer a wider range of services, so called “full service” firms.
Author Jim Miller cited Catalent, Lonza, Thermo Fisher Scientific/Patheon, and Wuxi AppTec as examples.
“While the CDMO industry remains fragmented, we have seen the emergence of ‘mega-CDMOs’, contract service providers generating $3 billion to $5 billion in revenues with the manufacturing scale, capabilities, and expertise to match all but the very largest biopharma companies.”
Miller also suggested formation of the mega-CDMOs had limited acquisition opportunities across the sector.
The report also looks at capacity in the CDMO sector and concludes that pharma industry demand will force contractors to expand.
Read the full report here.
Walmart, Merck and IBM to help US FDA with blockchain for drug T&T
The FDA has asked Merck, IBM and Walmart to help it develop a blockchain-based system for drug T&T.
According to a report by RAPS, the firms will work on the “interoperable track-and-trace system required under the Drug Supply Chain Security Act (DSCSA) by November 2023.”
The firms said, “The proposed network is intended to help reduce the time needed to track and trace inventory; allow timely retrieval of reliable distribution information; increase accuracy of data shared among network members; and help determine the integrity of products in the distribution chain, including whether products are kept at the correct temperature.”
As previously reported, the FDA has been looking at blockchain for some time. Blockchain technology refers to systems that create a permanent digital record of products each time they change hands, from API supplier to formulator to wholesaler and ultimately to end consumer.
Each transaction is referred to as a block and these blocks are chained together to create a record of the supply chain that everyone involved can access, but not edit.
Drug firms struggling with US T&T rules
In related news, drug firms are struggling to comply with track & trace measures introduced as part of the DSCSA.
According to a report by Healthcarepacking, pharmaceutical companies and the packaging sector are still investing to ensure they are in compliance with the elements of the Act that have been introduced to date.
The article points to the complexity of the business changes required and also to the FDA’s failure to respond to industry compliance efforts – particularly with respect to Unique Identifier guidelines – as part of the problem.
Gene therapy production costs are concern for the US FDA
The US FDA is worried about the rising cost of gene therapies and how companies will be able to scale-up production.
According to BiopharmaDive, Peter Marks, head of the Food and Drug Administration’s Center for Biologics Evaluation and Research, rates soaring gene therapy costs as his top concern.
He said, “When the cost of goods are very high, they help justify when people charge astronomical prices,” Marks said in a recent interview with BioPharma Dive.
“If we can help see cost of goods and ability to manufacture reproducibly improve, I think that’ll be a big thing. That’s something we’re working on but something that keeps me up at night.”
Read the full report here.
Also in the news
Regulators from Argentina, Israel, Jordan and Saudi Arabia have been approved by the International Council for Harmonisation (ICH).
Generic drug firms say stockpiling only is not enough to guarantee drug supplies if the UK withdraws from the European Union. Read more at the Pharmaceutical Journal.
The US FDA is not receiving as many applications for biosimilar drug development as expected according to a report by Pharmaintelligence.
The publication also looked at the importance of scale-up in gene therapy manufacturing.
Antibody-drug conjugates have entered the public consciousness. According to Bloomberg, ADCs could replace chemotherapy.
Developments in the CDMO space
AptarGroup has acquired services firms Nanopharm and Gateway Analytical. The former has capacity in oral and nasal drug production while the latter provides particulate detection and predictive analytical services to firms developing injectable medicines.
Camargo has bought drug development services firm InSymbiosis.
The EU has cleared Cognate Bioservices to manufacture advanced therapeutic medicinal products.