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.
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Gene therapy
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.
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…
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.
news
Experimental gene therapy reverses sickle cell disease for three years
The gene therapy corrected the shape of some sickle cell patients' red blood cells and eliminated episodes of severe pain.
news
Gene therapy sustains bleeding control in haemophilia A trial
Giroctocogene fitelparvovec had a mean annualised bleeding rate (ABR) of just 1.4 percent over two years, with no bleeding events in the first year post infusion.
article
Five marketing strategies for novel therapeutics
Long before the advent of Coronavirus, next-generation therapies were making headlines, but the successful development of COVID-19 vaccines, including mRNA vaccines, has now shone a spotlight on next-generation therapies. This offers a boost to the long-term growth projections for the advanced therapy medicinal products (ATMPs) sector. But although ATMPs hold…
news
Astellas and Dyno Therapeutics to develop AAV gene therapy vectors
Astellas and Dyno Therapeutics will develop adeno-associated virus (AAV) vectors for gene therapy directed to skeletal and cardiac muscle.
whitepaper
Whitepaper: Sterility testing – difficult products
This whitepaper considers sterility testing to support pharmacopoeial monographs with an emphasis on products that are difficult to test or validate.
whitepaper
Whitepaper: Accelerate biologics development via innovation
This whitepaper provides a roadmap for assessing and selecting the right partner to get promising biological therapies to patients quickly.
whitepaper
Whitepaper: Drug repurposing strategies to shorten timelines
This whitepaper explores drug repurposing, where known clinical candidates or commercially approved molecules are evaluated for new targets and indications.
whitepaper
Future of QA/QC for Complex Biologics Whitepaper
Download this whitepaper to discover the latest developments and research in QA/QC for biologic therapies via exclusive articles, interviews and application notes.
video
On-demand webinar: Water systems – microbial monitoring
This webinar considers the fundamental importance of water system control within pharma processing and the best control and monitoring practices.
whitepaper
Whitepaper: Impact of a pandemic outbreak on vaccine development approach
This whitepaper explores vaccine development during a pandemic, a response to complex challenges that traditional manufacturing methods will not solve.
