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).

Spotlight

BioTX Automation, Inc.

BioTX Automation, Inc. engages in the development, manufacture, and marketing of personal automation tools for use with reagent kits, and for error elimination in forensic, life sciences research, drug discovery, microarray, and diagnostics labs, as well as biological product manufacturers. BioTX operates in three market segments, Lab Products, Custom Automation and Marketing Tools.

OTHER WHITEPAPERS
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Early engagement and regulatory considerations for biotech

whitePaper | March 24, 2023

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

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Healthcare system readiness for the adoption of advanced therapies: learnings from the introduction of CAR T cell therapies in the UK

whitePaper | September 17, 2021

The adoption of CAR T therapies in the UK NHS is a success story, especially seen in relation to the experience in many other countries. The UK NHS showed itself to be agile, and responsive to addressing the unique challenges these therapies present, which facilitated access to patients earlier than in many other countries. (including delivery centre selection, development of service specifications, collaboration with manufacturers throughout the preparation phase for adoption, establishment of national multidisciplinary CAR T team to ensure equity of access and prioritization of resources (where needed)).

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The EU Clinical Trials Regulation − What You Need to Know

whitePaper | March 22, 2022

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.

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A New Generation of Cancer Immunotherapies

whitePaper | June 9, 2022

Despite recent progress in fighting cancer the sad reality is that it remains a leading cause of morbidity and mortality. Some of the most promising new treatments have emerged from the convergence of the oncology and immunology fields.

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Bispecific Antibodies - CMC Considerations

whitePaper | December 16, 2022

Bispecific antibodies (bsAbs) are genetically engineered, recombinant antibodies that consist of two distinct binding domains.

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Bioanalytical Techniques to Advance Biosimilars Development

whitePaper | August 22, 2022

Biosimilar therapies offer more unique approaches to treating patients with serious diseases, such as cancer.

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Spotlight

BioTX Automation, Inc.

BioTX Automation, Inc. engages in the development, manufacture, and marketing of personal automation tools for use with reagent kits, and for error elimination in forensic, life sciences research, drug discovery, microarray, and diagnostics labs, as well as biological product manufacturers. BioTX operates in three market segments, Lab Products, Custom Automation and Marketing Tools.

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