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.
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Biologics
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…
news
Novavax’s COVID-19 vaccine highly effective in preventing disease
New Phase III trial data suggests Novavax’s investigational COVID-19 vaccine, NVX-CoV2373, is 90 percent effective at preventing COVID-19 illness.
whitepaper
Application note: Setup and transfer of a gradient HILIC method
A fast and reproducible gradient HILIC method was set up for the impurity analysis of the hydrophilic temozolomide.
whitepaper
Supplement: ACC endotoxin
The launch of ACC's PyroSmart NextGen™ recombinant Cascade Reagent (rCR) marks the introduction of a new sustainable recombinant LAL reagent technology for bacterial endotoxin testing (BET).
article
European Pharmaceutical Review Issue 6 2021
This journal features articles discussing what knowledge could help the industry to prevent the next nitrosamine-like contamination event, the key steps when validating analytical techniques for cell and gene therapies and how artificial intelligence is shaping microbiology. Also in this issue, using Raman spectroscopy and hyperspectral imaging to detect counterfeit…
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Technical bulletin: Nitrosamine control: understanding the new FDA and EMA regulations
This technical bulletin discusses major regulatory updates, introduced by the FDA and EMA, regarding nitrosamines and SGS proposed risk assessment method for compliance.
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Application note: Solving the aggregation problem of HEK 293 cells
In this application note, we show a successful example of the adaptation of a human recombinant protein-expressing HEK293 cell line.
podcasts
EPR Podcast Episode 7 – Collaboration in ATMP development – Jérôme Larghero and Julien Textoris, bioMérieux
How important is collaboration in ATMP development? What can be done to expedite ATMP manufacturing and release? Find out about all this and more in this podcast with bioMérieux.
whitepaper
Whitepaper: Sterile formulation strategies to shorten timelines
This whitepaper reveals strategies to create simple, stable formulations for your sterile injectable, a solid foundation for your product’s lifecycle.
whitepaper
Brochure: PyroSmart NextGen™
The launch of ACC's PyroSmart NextGen™ recombinant Cascade Reagent (rCR) marks the introduction of a new sustainable recombinant LAL reagent technology for Bacterial Endotoxin Testing (BET).
whitepaper
Technical note: The content of nevirapine and related impurities
Guidance on generating an intelligent, automated workflow for batch-release analysis of an active pharmaceutical ingredient (API).
