50 How COVID-19 Affected the Freeze -Drying Industry and What Was Learned
2020 was a challenging year in the field of freeze drying/lyophilisation due to the sharp increase in demand and timelines required to get products to market. This was especially prevalent across the diagnostic and pharmaceutical, vaccine, antibody, and blood product sectors. Looking back on such a paradigm shifting year to gauge how the challenges were met and was has been learned allows understanding of the vital role freeze drying processing has played, how a limited cold chain affects getting products to climate sensitive regions, and how outsourcing lyo research and developmentR&D in lyo and for tackling the freeze-drying process efficiency and dynamically has played such a fundamental part in successfully getting products to end users safer and faster than ever before.
The process of freeze -drying is used for many applications including pharmaceuticals, biologics, food processing, and nutraceuticals, pharmaceuticals, and environmental services. It became apparent early in the pandemic, by the organisations who threw everything into diagnostics and vaccine research and development, that the importance of freeze -drying methods on a large scale, would be integral to vaccine product storage and distribution. [MC1]
Lyophilisation methods have been used extensively during the COVID-19 pandemic including in the research and development stage of covid specific vaccines and production of IVD Tests (In-Vitro Diagnostic) tests and in the production of the vaccines [MC2] themselves. [CH3] The difficulties faced by organisations involved in developing these vital resources, centred around the sheer volume, increased demand for products and the time taken to deliver them to market.
In 2020, we saw a significant demand for design and manufacturing of products that have diagnostic applications, which later evolved in the second half of the year to focus more also on the large-scale production research and development of potential COVID-19 vaccine candidatess for global distribution. Read the full article to discover how Biopharma Group adapted to offer effective solutions for both diagnostic and pharmaceutical products.
More information online:
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New Human Plasma-Like Cell Culture Medium Announced
Thermo Fisher Scientific has launched the new Gibco Human Plasma-like Medium (HPLM), the first cell culture medium on the market that mimics the metabolic profile of human plasma that is designed to provide researchers with a realistic view of cell growth within the human body.
Gibco HPLM contains the same salt concentrations found in human plasma, as well as the same concentrations of over 60 polar metabolites, such as amino acids, nucleic acids, sugars and small organic acids. By resembling the natural cellular environment found in the body, HPLM provides researchers the ability to study the impact of physiologically relevant cell media on their specific research applications, including cancer and other diseases. When supplemented with foetal bovine serum (FBS), HPLM can support cell growth and viability that are comparable to that of conventional basal media formulations supplemented with FBS. For most cell lines, adaptation is not required to transition from conventional medium to HPLM.
“Innovative technology such as the Gibco Human Plasma-Like Medium is testament to the incredible work being led by Thermo Fisher’s research partners,” said Amy Butler, President of Biosciences, Thermo Fisher Scientific. “Collaboration between industry and academia is vital to the pursuit of innovation and development of fit-for-purpose materials that improve scientists’ understanding of human disease and strategies to address them.”
Human Plasma-like Medium was invented by Jason R. Cantor of the Morgridge Institute for Research in Madison, Wisconsin and David M. Sabatini of the Whitehead Institute at the Massachusetts Institute of Technology in Cambridge, Mass. Drs Cantor and Sabatini are inventors on a patent application for HPLM assigned to Whitehead Institute.
More information online:
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High Performing Pumps Maintain Vaccine Quality
Vaccine discovery and production has jumped to top of the priority list for most pharmaceutical companies. Increased interest in developing biopharmaceutical therapeutics with injection-delivered large-molecules has shone the light on aseptic processing in both upstream and downstream operations. Stricter validation requirements and a need for design innovation have led manufacturers to demand more from their peristaltic pump suppliers.
The Longer Pump series from PCT offer many clear benefits for both production and quality control engineers. The utilisation of single use tubing within peristaltic pumps eliminates the risk of cross-contamination and, as only the inside of the tubing comes into contact with the media, it also eliminates lengthy cleaning procedures. Validation is therefore significantly easier. As many biological drugs are shear-sensitive, the gentle action of peristaltic pumps protects them by applying only low pressure at minimal speed. Changing a peristaltic pump’s tubing size varies the fill and flow range that is achievable. Optimising the variation of flow speed during the whole cycle brings different benefits at different times. Early in the process a decrease in speed can avoid foaming and splashing whilst an increase in the latter stages will improve overall batch time. A quality peristaltic pump should have the ability to switch between application requirements; accurate variable flow speeds, precise dispensing volumes, an extensive selection of interchangeable single-, dual- and multi- pump heads to cover all the tubing options required and last but not least, quick and simple tube changes ensure a stress-free life for the operator.
More information online:
ilmt.co/PL/PaMm 54658pr@reply-direct.com
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