Pfizer, Moderna vow to ramp up COVID-19 vaccine delivery | USP developing quality standards for continuous manufacturing | Cooperation with regulatory agencies key in cell, gene therapy development
The US could have 3 million available COVID-19 vaccine doses per day by April, based on numbers shared by major vaccine makers in a House committee hearing Tuesday. Pfizer said it plans to boost its delivery capacity to more than 13 million doses per week by mid-March, while Moderna expects to increase its supply capacity to more than 40 million doses per month by April.
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The pharmaceutical industry standards-setting body US Pharmacopeia and Phlow will collaborate at Virginia Commonwealth University's Medicines for All Institute to develop quality standards for drugs made using continuous manufacturing. The US FDA references USP standards, and the new standards might encourage drugmakers, including makers of generic drugs, to invest in new equipment in the US.
Fewer than two dozen cell and gene therapies have been approved in the US, and Orchard Therapeutics founder and CEO Bobby Gaspar says it's important to work with regulatory authorities throughout the development and commercialization process. "The industry is stepping into new territory as we tackle clinical, scale-up, and commercial challenges, and so are the regulatory agencies," Gaspar says.
A study published in Nature Communications describes how researchers in Japan were able to separate the oxygen molecules O-18 and O-16 using nanoporous carbon. O-18, an essential isotope for detecting cancer in PET scans, is hard to procure, and researchers foresee greater demand for the process and distilled O-18 in the future.
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A site 70 miles east of Moscow where biological weapons were developed now houses Generium Pharmaceutical's high-tech facility mass-producing Russia's COVID-19 vaccine. Engineers have scaled up to produce several million doses a month and are heading toward 10 million to 20 million a month, says Chief Science Officer Dmitry Poteryaev. At least 30 countries have ordered nearly 2.5 billion doses, but one scientist says less than 2% of Russians have received at least one dose.
GlaxoSmithKline is closing antibiotics manufacturing plants in Barnard Castle and Ulverston, England, and selling its cephalosporin business to Novartis' Sandoz unit, and Integral Pharma Services consultant Keith Plumb says the closure is a sign "the UK is missing out on the move to bioprocesses, with a subsequent significant loss of manufacturing skills." However, startup contract drugmaker Lakes BioScience is building a monoclonal antibody facility at a GSK site in Ulverston.
The Biovac Institute's planned expansion and Aspen Pharmacare's agreement to produce Johnson & Johnson's COVID-19 vaccine will relieve South Africa's reliance on other countries for vaccines. Biovac started making a pediatric vaccine licensed from Sanofi Pasteur last year, will start making pneumococcal vaccines licensed from Pfizer this year and could start making a COVID-19 vaccine within a year, says CEO Morena Makhoana.
Prices for polymer resins in Europe are at their highest since 2015 amid high demand and short supply. Shortages of plastics affect drug packaging and products used in vaccine manufacturing.
President Joe Biden is ordering a 100-day review of potential supply chain vulnerabilities in pharmaceuticals, computer chips, large capacity batteries and rare earth minerals, followed by a broader review of supply chains in public health, transportation, food, energy and other critical sectors.
The US FDA updated guidance on its website for drugmakers that aim to adapt their COVID-19 products, such as vaccines, diagnostics and therapeutics, to emerging coronavirus variants. The agency will not require extensive clinical testing of modified products, but it will require data demonstrating safety and efficacy similar to reference products.
Aseptic filling of parenterals is one the most challenging tasks within pharmaceutical manufacturing. There is a wide range of topics that fall under this umbrella, from more engineer-driven topics like filling accuracy and machine performance to key production questions, like how to keep the process sterile and compliant within the law and regulatory guidelines. Full Story: iSpeak
At the ISPE Singapore Affiliate's 20th Anniversary Conference on 9-12 December 2020, two international regulators and a senior representative from industry discussed current and future collaboration between industry and regulatory authorities. Full Story: iSpeak
