In this week’s news, move for CMC data standardization gains momentum, industry seeks clarity on CAR-T testing rules and more.
Calls for CMC quality data standardization gaining traction
Regulators’ calls for a global initiative to help standardize CMC quality data are staring to gain some traction.
According to a report by RAPS the plans – which were discussed at the Drug Information Association’s annual meeting in Chicago – aim to harmonize chemistry, manufacturing, and controls (CMC) information submitted in the Common Technical Document (CTD). As Nina Cauchon, director of regulatory affairs CMC at Amgen sees it the harmonization idea is a no brainer.
“The problem statement is that even though many companies are global and have a common product … the fact that there are differing regulatory requirements means that there is not a single global dossier.
CAR-T sector wants US FDA clarity on starting materials
Doctors and industry want the US FDA to clarify rules on the evaluation of cellular starting materials for chimeric antigen receptor (CAR) T cell product development.
The call for clarity – which was published this week – was part of the response to the FDA guidelines of CAR-T product manufacturing that were issued in March.
Also in the news
Endpoints reported the PIC/S is to resume onsite assessments for countries applying for membership. The organisation ceased inspections as a result of the pandemic.
The Centre for Breakthrough Medicines plans to up capacity for the development of cancer cell therapies according to an Endpoints article.
BioNTech has started work on an mRNA manufacturing facility began in Kigali, Rwanda. The company expects to set up additional factories in Senegal and South Africa in close coordination with its partners in the respective countries.
Business Live reported that GSK has opened a facility at its Barnard Castle site after a £90m investment.
BioSpectrum looked at the shifting dynamics of the fast growing Asia pacific contract manufacturing and development services market.
Biopharm looked at how modelling approaches have been gaining popularity in the biopharma industry with companies seeking ways to maintain drug development costs.
Biopharmadive reported the FDA could approve a first-of-its-kind autoimmune drug and two gene therapies as well as decide how COVID-19 vaccines should be updated.
Pharmtech reported that regulators seek more drug effects research related to pregnancy and lactation
Fiercepharma looked at how the M&A landcape is tilting away from late-stage buys and toward a platform strategy
Some developments of note in the contracting sector:
German drug maker Merck has doubled its high-potent active pharmaceutical ingredients (HPAPI) production capacity with the expansion of its facility in Verona, near Madison, Wisconsin, US.
Lonza and Adva Biotechnology have entered into a license agreement that will provide Adva access to core intellectual property enabling the expansion of automated bioreactors globally.
OrganaBio has started GMP manufacturing operations at its new cell therapy manufacturing facility in Miami.
CPC Scientific has invested in a new peptide API manufacturing site in Rocklin, California.
Charles River Laboratories and Ziphius Vaccines have signed an agreement to manufacture starting materials critical to clinical-stage research.
Kindeva Drug Delivery has completed the acquisition of iPharma Labs, located in San Francisco’s Bay Area.