BIOPHORUM OPERATIONS GROUP (BPOG) BEST PRACTICES GUIDE FOR EVALUATING LEACHABLES

Use of single-use systems (SUS) and SUS components in clinical and commercial biopharmaceutical manufacturing has increased rapidly in recent years. Polymeric SUS components offer significant advantages over conventional (i.e. reusable) components in terms of flexibility, speed and efficiency of operation.

Spotlight

SYNTHELIS

Synthelis provides a solution to a well known challenge in terms of biotechnological production – namely the synthesized production of membrane proteins. Around 30% of the human genome is coded for protein membranes. This family of proteins is involved in key biological processes such as cellular signaling, energy transduction or metabolic transportation. Anomalies affecting their structure or function can be directly or indirectly linked to a large number of pathologies. Consequently these molecules are the target for a large number of medicines currently planned for development.

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Microfluidics: Big developments on thesmall scale

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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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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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whitePaper | August 22, 2022

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Bispecific Antibodies - CMC Considerations

whitePaper | December 16, 2022

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Spotlight

SYNTHELIS

Synthelis provides a solution to a well known challenge in terms of biotechnological production – namely the synthesized production of membrane proteins. Around 30% of the human genome is coded for protein membranes. This family of proteins is involved in key biological processes such as cellular signaling, energy transduction or metabolic transportation. Anomalies affecting their structure or function can be directly or indirectly linked to a large number of pathologies. Consequently these molecules are the target for a large number of medicines currently planned for development.

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