Cell and Gene Therapy

Use of PS-DVB Columns and Matched Buffers in the Purification and Scale-Up of mRNA Drug Candidates

August 24, 2022

Use of PS-DVB
The validity of mRNA as an approved pharmaceutical is now largely accepted, with the historic launch and administration of billions of doses of mRNA Covid vaccines (1).

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Asahi Kasei Bioprocess America, Inc.

As a global partner to the biopharmaceutical industry, Asahi Kasei Bioprocess helps biologics manufacturers safely and efficiently produce medicines that patients can trust,

OTHER WHITEPAPERS
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BIOTECHNOLOGY INNOVATION ORGANIZATION

whitePaper | January 4, 2022

The Biotechnology Innovation Organization (BIO) appreciates the opportunity to participate in the 2022 Special 301 Review: Identification of Countries under Section 182 of the Trade Act of 1974: Request for Public Comment and Announcement of Public Hearing.

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Next-Generation Technology, Procedures, and Products Facilitate Biopreservation Best Practices for Cellular Therapies.

whitePaper | August 19, 2022

The quality of procedures and products used for preparing, transporting and storing cells at cryogenic temperatures have a direct impact on post-thaw viability and functionality, as well as the consistency and reliability of biological agents from a Quality perspective.

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Gene, Cell, & RNA Therapy Landscape

whitePaper | January 24, 2022

The American Society of Gene & Cell Therapy (ASGCT) is the primary professional membership organization.

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The colors of life: an interdisciplinary artist-in-residence project to research fungal pigments as a gateway

whitePaper | January 10, 2022

Biological pigmentation is one of the most intriguing traits of many fungi. It holds signifcance to scientists, as a sign of biochemical metabolism and organism-environment interaction, and to artists, as the source of natural colors that capture the beauty of the microbial world.

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Producing therapeutic peptides using biotechnology

whitePaper | October 20, 2022

We began the project by working to the design of a recombinant bacterial strain selection of a strain capable of producing high concentrations of peptides.

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Benefit-Risk Considerations for Product Quality Assessments; Guidance for Industry; DRAFT GUIDANCE

whitePaper | May 10, 2022

This guidance describes the benefit-risk principles applied by FDA when conducting product quality-related assessments of chemistry, manufacturing, and controls (CMC)2 19 information 20 submitted for FDA assessment as part of original new drug applications (NDAs) under section

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Spotlight

Asahi Kasei Bioprocess America, Inc.

As a global partner to the biopharmaceutical industry, Asahi Kasei Bioprocess helps biologics manufacturers safely and efficiently produce medicines that patients can trust,

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