whitepaper
Technical note: System precision in HPLC analysis of APIs and impurities
HPLC users expect robust, reliable systems with equivalent performance and reproducibility between systems that greatly facilitates method transfer.
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Biologics
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Event review: The Future of QA/QC for Complex Biologics
On 30 November and 1 December 2021, European Pharmaceutical Review hosted its first ever event – The Future of QA/QC for Complex Biologics Online Summit. Bringing together more than 600 attendees, 15 expert speakers and Thermo Fisher Scientific and Merck as sponsors, the summit gave industry experts the chance to…
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Critical steps when validating an assay or analytical method for cell and gene therapy products
Dr Kiren Baines, Analytics Lead at eXmoor Pharma, details some of the critical steps when validating an assay or analytical method, including key considerations for developing an experimental plan aligned with ICH guidelines.
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The weakest link – biopharma workforce development
Killian O’Driscoll, Director of Projects at the National Institute for Bioprocessing Research and Training (NIBRT), highlights the plight of a future skills shortage in the global biopharma industry as state-of-the-art therapy production evolves at a rapid pace.
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Enhancing efficiency and economics in process development and biotherapeutics
Discover how GSK and Aragen Biosciences streamlined their processes using various techniques that produced multiple benefits, including increased throughput, improved quality control and reliable automation.
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Bioprocessing & Bioproduction In-Depth Focus 2021
In this in-depth focus, experts discuss how a future skills shortage may impact the biopharma industry and the key considerations when validating assays and analytical methods for ATMPs.
news
EMA recommends GSK’s Xevudy for the treatment of COVID-19
The EMA has recommended granting marketing authorisation for the use of Xevudy (sotrovimab) to treat COVID-19 in adults and adolescents.
video
Video: Horseshoe crab sustainability project: 1 million and counting!
Associates of Cape Cod, Inc.'s one of a kind sustainability project meets a milestone of one million juvenile horseshoe crabs released in Massachusetts!
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Many hands make light work: why the new Bespoke Gene Therapy Consortium is a godsend for ambitious biopharma teams
In late October, we learned that an exciting and ambitious new entity – the Bespoke Gene Therapy Consortium (BGTC) – had come into being in the US, designed to encourage the delivery of more gene therapies for rare diseases. The consortium is an interesting construct, headed and funded by the…
whitepaper
Whitepaper: CMC regulatory landscape, cell and gene therapy products
This whitepaper gives an understanding of the evolving regulatory guidelines for cell and gene therapies, in order to bring them to market faster.
news
ABPI publishes new roadmap to aid in ATMP development
The roadmap clarifies the processes to develop advanced therapy medicinal products (ATMPs), providing guidance on key considerations.
whitepaper
Catalogue: ACC products & services
Associates of Cape Cod, Inc. (ACC) has been a global leader in endotoxin and (1→3)-ß-D-glucans detection products and services for nearly 50 years.
whitepaper
Technical paper: Low risk frozen distribution of SU bags for bioprocessing
This paper discusses the results of a study that help to mitigate the risks during frozen shipping and ensure consistent product quality in cold chain.
whitepaper
Case study: GC-MS for cGMP nitrosamine testing
What pharmaceutical QA/QC laboratories need to know to overcome the challenges of nitrosamine impurities in drugs for cGMP testing.
article
Challenges and innovations shaping the bioprocessing industry
In this article, Robert Newman and Tom Fletcher explore how the bioprocessing industry has changed in the last 50 years and where the future may lead…
