Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products

The primary concern with unintended humoral immunogenicity of biological products for manufacturers, regulatory agencies, clinicians and patients is whether antibodies produced by patients receiving the product result in clinical sequelae. However, the assessment of the correlation between immunogenicity and clinical sequelae is entirely dependent on the appropriate detection, measurement and characterization of antibodies against biological therapeutics.

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Offspring Biosciences AB

Offspring Biosciences provides contract research services to the Pharma and Biotech industry, using advanced histopathology-based analytical techniques.

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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Application of Single-Use Technologies(SUT) in Biosimilar Development

whitePaper | December 20, 2022

The current processing paradigm of large manufacturing facilities dedicated to singleproduct production is no longer an effective approach for best manufacturing practices.

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Scalable Rubella production in scale-X™ bioreactor with MRC-5 cells

whitePaper | November 18, 2022

Due to vaccine delivery gap for Rubella disease, global immunization is still limited in some parts of the world. In this paper we will demonstrate how one scale-X™ carbo fixed-bed bioreactor system.

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Accelerating the Biomanufacturing Revolution

whitePaper | February 11, 2022

The biomanufacturing revolution is here. Recent advancements in the field of synthetic biology have enabled significant cost reductions in foundational bioengineering unit operations such as DNA synthesis and sequencing.

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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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Further Discussion on Plasmids to Establish Release Specifications Using a Risk-Based Approach to Manage Supply

whitePaper | December 6, 2022

BioPhorum’s mission is to create environments where the global biopharmaceutical industry can collaborate and accelerate its rate of progress, for the benefit of all.

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Spotlight

Offspring Biosciences AB

Offspring Biosciences provides contract research services to the Pharma and Biotech industry, using advanced histopathology-based analytical techniques.

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