In this week’s news, Woodcock steps in at FDA, new guidelines for CGT CDMOs and more…
Covid-19 vaccine demand to boost services sector in 2021 says report
Demand for Covid-19 vaccines will benefit the contract distribution services and packaging sectors in 2021 according to an industry think tank.
The Conference Board – a business membership and research group that counts over 1,000 public and private corporations from 60 countries as members- made the prediction last week, explaining it is based on a survey of CEOs and executives.
According to the authors “CEOs believe the distribution of a successful vaccine will have a significant impact on their businesses in the coming year and is likely contributing to their more positive view of future growth prospects.”
They add that, “The spread of COVID vaccines will also provide greater clarity and predictability around short term planning and operations, such as when physical workplaces can reopen and the dependability of supply chains.”
Center for Drug Evaluation and Research (CDER) director Janet Woodcock has been appointed as US FDA acting commissioner.
Woodcock takes over from Stephen Hahn, who resigned this week.
In a note to Agency staff Woodcock said she will continue in her role in Operation Warp Speed, at least temporarily, to support the development of COVID-19 therapeutics.
“To help with the transition, I’ve been asked to continue some work with the therapeutics development effort. This work will involve government-sponsored research and clinical trials, and other matters that would be appropriate for an FDA employee. I will not be involved in contract discussions or similar matters with individual companies.”
Woodcock is the longest serving leader of the CDER. She is also a supporter of continuous production and manufacturing innovation.
Cell therapy CDMOs asked to guard against SARS-CoV-2 contamination
CDMOs working in the cell and gene therapy space must check their manufacturing facilities, processes and products for potential coronavirus contamination under new guidelines issued by the US FDA.
The agency introduced the requirement this week, telling all firms making cell and gene therapies.
It wrote that while it “is not aware of any CGT products that have been contaminated with SARS-CoV-2…to ensure compliance with current good manufacturing practice (CGMP) requirements, CGT manufacturers are expected to evaluate whether it poses new risks in the context of their specific products, facilities, processes, and manufacturing controls.”
The FDA also asks manufacturers to guard against the accidental expansion of SARS-CoV-2 virus during cell culture of autologous or allogeneic cells, if they were infected with the virus.
No material testing recommendations are in the guidance, but the agency does stress that manufacturers meet CGMP requirements including those applying to quality and documentation in management systems.
Also in the news
Some US hospitals say the syringes in which the Government is supplying Covid-19 vaccines, often result in considerable product wastage. Read the full Politico report here.
US President Joe Biden has put forward a Covid-19 vaccination plan that would increase domestic production according to the Pink Sheet.
Some developments of note in the contracting sector:
Samsung Biologics set forth its dynamic growth plan for the next decade at the 2021 Annual JP Morgan Healthcare Conference.
Boy Tjoa, Director of Operations at Tjoapack, explores the challenges of maintaining sterility when packaging prefilled syringes and discusses how to tackle the complex requirements associated with parenteral products.
Sanofi has set up an API production firm. The company – called EuroAPI – will cater for drug companies that want to source actives from Europe.
Novavax has hired Baxter International to provide sterile manufacturing services for NVX-CoV2373, a COVID-19 recombinant nanoparticle vaccine candidate.
Thermo Fisher has acquired Novasep’s viral vector manufacturing business in Belgium for approximately €725 million.
Catalent announced plans to buy Acorda Therapeutics’ dry powder inhaler and packaging business
Lonza is waiting for Swissmedic to license a Covid-19 vaccine API production line at its facility in Visp. Read the Reuters report.
Bioprocess Insider reports Thermo Fisher Scientific expects to generate $6bn in revenue from Covid-19-related projects.