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FDA grants emergency use authorisation to COVID-19 antibody bamlanivimab
The neutralising antibody therapy bamlanivimab (LY-CoV555) is authorised for emergency use in recently diagnosed patients who are at risk of developing severe COVID-19.
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Biologics
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Using Th17 cells researchers make adoptive T-cell transfer therapy viable
Adoptive T-cell transfer therapy has had limited use due to the time involved in CD8+ T cell expansion, using a different type of T cell researchers were able to shorten this timeline, making the therapy more accessible.
webinar
How to master raw material ID testing in 2021
11 November 2020 | By Thermo Fisher Scientific
In this on-demand webinar we explore the evolving role of handheld and portable instruments to drive quality improvements and manufacturing success in 2021.
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COVID-19 therapeutics to rely on large-scale biomanufacturing reactors, report says
A new report has found that if COVID-19 biologics are approved, it could apply pressure to the global biomanufacturing capacity.
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CVnCoV COVID-19 vaccine safely elicits immune response in Phase I testing
The interim Phase I data suggests CVnCoV can safely induce a neutralising antibody response similar to that of convalescent COVID-19 patients with two 12μg vaccine doses.
whitepaper
Fact sheet: TOC monitoring efficiency quiz
Take our 10-question quiz to find out how efficient your Total Organic Carbon (TOC) monitoring programme is for your applications.
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Takeda to supply Japan with Moderna’s COVID-19 vaccine
Takeda will import and distribute 50 million doses of the mRNA-1273 vaccine candidate under an agreement with Moderna and Government of Japan.
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FDA approves first-in-human trial of COVID-19 vaccine candidate
The safety and immunogenicity of CORVax12, a novel DNA-encodable COVID-19 vaccine, will be evaluated in 36 healthy volunteers.
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US to receive 300,000 vials of experimental COVID-19 antibody therapy
Eli Lilly will provide the US government with vials of its COVID-19 antibody therapy bamlanivimab (LY-CoV555) if the treatment is granted Emergency Use Authorisation.
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Alternative routes of administration – a focus on oral biologics
A major challenge in achieving clinically relevant oral delivery of biologics is overcoming the multiple physiological barriers in the gastrointestinal tract. In this article Nikki Withers discusses these challenges with Shawn Davis, Head of Drug Delivery, BioPharmaceuticals Development, R&D at AstraZeneca, who shares some of the latest advances in drug…
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Expert view: The OXYCAPT™ multilayer plastic vial and syringe provides solutions for problems with current primary containers
There are several problems with existing primary containers; for example, glass suffers from breakage, delamination, etc., and plastic is an insufficient oxygen and ultraviolet (UV) barrier.
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Biologics: a leadership journey
Behind every technological advance there is often a leadership story just as interesting. In this article, Ben Woollard highlights key leadership behaviours that have been fundamental in biological innovation and suggests how businesses can implement these attributes to strive forward in a new era of biologics.
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Bioprocessing & Bioproduction In-Depth Focus 2020
Articles in this in-depth focus discuss the challenges facing advanced therapy medicinal product developers and which leadership qualities could be implemented to drive innovation in biologics.
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Bioanalytical testing services market to become a $4.5 billion industry
A report found the rise in outsourcing, growing popularity of biologics and expanding acceptance of quality-by-design approaches would drive the market expansion.
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European Pharmaceutical Review Issue 5 2020
In this issue you can find articles discussing the supply chain implications of Trump's 'Buy American' order, guidance on how to identify and justify starting materials for regulatory approval by both the EMA and FDA, as well as some of the latest developments in oral biologic drug delivery techniques. Also…
