Cell and Gene Therapy, Industrial Impact

The EU Clinical Trials Regulation − What You Need to Know

March 22, 2022

The EU Clinical
The Clinical Trials Regulation has retained some definitions and refined others. For example the definition of “clinical study”: “Any investigation in relation to humans intended: (a) to discover or verify the clinical, pharmacological or other pharmacodynamic. 

Spotlight

poly

Plantronics, Inc. (“Poly” – formerly Plantronics and Polycom) (NYSE: PLT) is a global communications company that powers meaningful human connection and collaboration. Poly combines legendary audio expertise and powerful video and conferencing capabilities to overcome the distractions, complexity, and distance that make communication in and out of the workplace challenging. Poly believes in solutions that make life easier when they work together and with our partner’s services. Our headsets, software, desk phones, audio and video conferencing, analytics and services are used worldwide and are a leading choice for every kind of workspace.

OTHER WHITEPAPERS
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Understanding Single-Pass Tangential Flow Filtration and the New Era of Bioprocessing

whitePaper | December 22, 2022

Single-pass tangential flow filtration (SPTFF) technology from Pall Corporation is revolutionizing current and future bioprocessing platforms with its implementations in biotech, vaccine and plasma industries. Its features are protected by a portfolio of patents[1-6].

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Small Molecule Apis Made with Compelling Science

whitePaper | July 17, 2023

As your API demand grows, we grow with you. While we can manufacture volumes in metric tons, we can also go small. If you have a chemistry-based compound and need smaller batches for clinical or commercial use, we can offer the quantities you need at our cGMP small-scale/pilot facilities until you’re ready for full-scale manufacturing.

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Growing a circular economy with fungal biotechnology

whitePaper | August 17, 2022

Fungi have the ability to transform organic materials into a rich and diverse set of useful products and provide distinct opportunities for tackling the urgent challenges before all humans.

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Quality Control Solutions for Cell and Gene Therapy

whitePaper | September 10, 2022

Droplet Digital PCR (ddPCR) provides highly precise and absolute quantification of nucleic acids by counting nucleic acid molecules encapsulated in discrete water-in-oil droplets.

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Advanced Biopharmaceutical Manufacturing: An Evolution Underway

whitePaper | June 5, 2022

The past decade has seen a significant shift in the nature of the products being manufactured and sold by the innovative biopharmaceutical (biopharma) industry. The global biopharmaceutical portfolio of today reflects increased therapeutic competition, a greater prevalence of large molecule drugs, expansion in the number of personalized or targeted products, and a rise of treatments for many orphan diseases.

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Early engagement and regulatory considerationsfor biotech

whitePaper | May 10, 2022

Biotechnology companies are at the epicenter of innovative drug development, with discoveries spanning from small molecules, large molecules, and biologics to genomic medicines

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Spotlight

poly

Plantronics, Inc. (“Poly” – formerly Plantronics and Polycom) (NYSE: PLT) is a global communications company that powers meaningful human connection and collaboration. Poly combines legendary audio expertise and powerful video and conferencing capabilities to overcome the distractions, complexity, and distance that make communication in and out of the workplace challenging. Poly believes in solutions that make life easier when they work together and with our partner’s services. Our headsets, software, desk phones, audio and video conferencing, analytics and services are used worldwide and are a leading choice for every kind of workspace.

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