Pharmaceutical development and manufacturing have been intently focused on COVID-19 for the past year, but the sector appears to be returning to normal, as the late-stage drug pipeline is 17% larger and the early-stage pipeline is 25% larger than a year ago, according to investment firm William Blair. Executives at Cambrex, Catalent, Lonza and Siegfried say they expect strong demand this year.
Pfizer raised its COVID-19 vaccine production goal to 2 billion doses this year as new US government recommendations add 128 million people to the eligibility list. Pfizer has committed to making 600 million doses for the EU and 200 million for the US. New vials will be labeled for six doses instead of five, and a more accurate syringe will accompany the vials.
A new partnership between Boehringer Ingelheim and Google Quantum AI will apply quantum computing to pharmaceutical research and development. Quantum computing can simulate and compare molecules that are larger than other computing methods can handle, and it could accelerate and enhance drug discovery, according to the pharma company.
Vaccine vials are made of durable, temperature-resistant borosilicate glass, most of which the world sources from outside the US, and medical glass manufacturer Schott AG says it has already received requests for twice as many vials as it can produce in a year, writes MxD CEO Chandra Brown. In the US, the government could invoke the Defense Production Act to compel manufacturers to produce vials, commit to purchasing vials and offer direct loans or loan guarantees for scaling up production, Brown writes.
The UK Medicines and Healthcare products Regulatory Agency's spreadsheet of good manufacturing practice inspection data for 2019 ran more than 5,300 lines, and Unger Consulting analyzed the data in a two-part set of articles. Quality Systems, Chapter 1 is the most frequently cited inspection deficiency; and Computerised Systems, Annex 11 is in the top 10 for both critical and major deficiencies, writes Barbara Unger, co-lead of the Rx-360 Data Integrity Working Group.
Developers of cell and gene therapies are figuring out how to "take Petri dish science, mass produce it, and turn it into pharmaceutical grade medicine," says Avrobio CEO Geoff Mackay. "Roboticizing" manual processes increases scale and quality, and Avrobio optimized and refined fully automated pods that mass produce cryopreserved gene therapy as a final drug product for bone marrow transplant, Mackay says.
The use of innovative mRNA technology to develop the COVID-19 vaccines from Pfizer and Moderna will soon be applied to develop novel applications for mRNA vaccines, particularly other infectious diseases. Moderna on Monday announced it now has a program focused on developing vaccines for the seasonal flu, HIV and the Nipah virus, while results from its COVID-19 vaccine trials in young children aren't expected until 2022, according to CEO Stephane Bancel.
Janssen and Legend Biotech have begun a rolling submission of a biologics license application for ciltacabtagene autoleucel, or cilta-cel, their chimeric antigen receptor T-cell therapy candidate. The partners are seeking approval as a treatment for adults with relapsed or refractory multiple myeloma.
Companies in the pharmaceutical sector should have a COVID-19 safety toolkit that centralizes resources for complying with new regulations and ensuring safety, writes Marta Kalas, co-founder of Thomson Screening. Components include a governance framework, individual and group risk assessments, an action plan and a communication plan that relies on trustworthy information sources, Kalas writes.
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