In this week’s news, FDA wants feedback on continuous manufacturing guide and more…
US FDA seeks input on new continuous manufacturing guidance draft
The US FDA has asked for feedback on its draft guidelines for the ICH Q13 guidance document on continuous manufacturing.
The US regulator asked for industry input in a post in the Federal Register, explaining the guidance was prepared under the auspices of the International Council for Harmonisation (ICH).
It wrote, “The draft guidance provides clarification on continuous manufacturing (CM) concepts and describes scientific approaches and regulatory considerations specific to CM of drug substances and drug products. The draft guidance is intended to provide scientific and regulatory considerations for the development, implementation, operation, and life-cycle management of CM.”
Interested parties are asked to submit comments by December 13.
EMA cites lack of data as challenge for biosimilars pilot
A lack of data is hampering the EMA’s ability to advise biosimilar developers according to an agency report.
The Amsterdam-based regulator published its report on the biosimilar pilot programme last week, explaining the lack of information had negatively impacted the scientific advice program which was launched in February 2017.
The EMA also said that current guidelines that assume biosimilar developers will take a stepwise approach – first clinical studies before analytical comparability studies – do not reflect industry trends where studies are conducted alongside comparability studies.
Also in the news
DCAT took a look at trends in the API and HPAPI space and identified many opportunities for CDMOs that are able to invest.
Bloombergreported the detection of so-called “azido impurities” is some blood pressure drugs. According to the article the US FDA has detected production issues at “at least” one manufacturer in India.
The US Government has saved $338 billion through generic drugs so far this year according to a report by the Association for Accessible Medicines. The report also indicates that 90% of prescriptions in the country have been filled by non-branded drugs.
Reuters reported that Bayer has terminated a vaccine manufacturing partnership under which it would have produced CureVac’s COVID-19 shot.
PTC Therapeutics has opened a gene therapy manufacturing facility in Hopewell, New Jersey. See press release.
Some developments of note in the contracting sector:
PCI has agreed to buy Lyophilization Services of New England, Inc. (LSNE) from global private equity firm Permira. See press release.
In related news, LSNE has doubled its sterile drug product lyophilization capacity at its Madison, Wisconsin. See press release.
Avid Bioservices is expanding into the cell and gene therapy market. The CDMO is constructing a viral vector development and CGMP manufacturing facility in Costa Mesa, California. See press release.
Pace Analytical Life Sciences, a subsidiary of CDMO Pace Analytical Services has acquired Velesco Pharmaceutical Services, a specialist in liquid, semi-solid, and oral solid dose product development. See press release.
National Resilience and Harvard University have established a five-year research and development alliance with a $30 million commitment from Resilience for the development of biologics, vaccines, nucleic acids and cell and gene therapies. See press release.