Newsletter | April 8, 2026

04.08.26 -- Rethinking ATMP Assurance When Sterility Timelines, Reality Misalign

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Non-Affinity Approach to Fc-Fusion Purification

A two-step, non-affinity purification strategy offers a powerful alternative to traditional Protein A chromatography for Fc-fusion proteins. While Protein A remains a widely used method, its low-pH elution can result in protein denaturation and degradation. We present a two-step purification workflow with a weak anion exchange-hydrophobic resin, followed by a strong anion exchange resin. This process achieves high-purity, high-yield purification of EGFR:Fc fusion proteins, while preserving protein integrity. Watch now.

FOCUS ON DOWNSTREAM MANUFACTURING

Building A Fully Single-Use Process With Protein A Membrane Devices

Explore results from a study demonstrating the capability of an intensified, single-use downstream process for a fed-batch cell culture harvest producing a representative mAb at an industrial scale.

Large Scale Purification Of Oligonucleotides With IEX

As oligonucleotide-based drugs gain momentum in therapeutic development, refining their manufacturing processes through solutions like ion exchange chromatography (IEX) becomes crucial.

Unlock The Future Of Biotherapeutic Purification

This novel CH1 binding resin addresses purification challenges with Fab fragments and bispecific antibodies. Learn how to simplify downstream workflows and support sustainable manufacturing.

DOWNSTREAM MANUFACTURING SOLUTIONS

Blood Infusion Syringe Filter For Microaggregate Removal - Charter Medical

Optimize Your Downstream Yield: The Purity Advantage Of Rec. GMP Trypsin - Roche CustomBiotech

FOCUS ON FILL-FINISH

Rethinking ATMP Assurance When Sterility Timelines, Reality Misalign

The compendial 14-day sterility testing window exposes product and patient to numerous risks, but settling on a rapid alternative also presents its own set of challenges.

Prefillable Syringe Success Factors For Emerging Biotech Companies

Navigating PFS selection requires balancing complex regulatory requirements and supply chain logistics. Adopting an integrated system approach provides unified data and streamlined documentation.

Factors To Consider While Selecting Stoppers For Lyophilized Vials

Ensure the success and stability of your lyophilized products by choosing the right container-closure system — discover your stopper options, here.

Fluid Connection Technologies For Sterile Fill and Finish Process Design

Single-use technology and innovative fluid connections play a significant role in creating an effective, sterile fill and finish operation that maintains the integrity of your biologic products.

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