Newsletter | May 14, 2025

05.14.25 -- Challenges In Manufacturing TIL For Clinical Trials

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Webinar: Building a Purification Toolkit for an Expanding Variety of mAb Therapeutics

Join our webinar to discover how to build a versatile downstream processing toolkit, match diverse antibody formats to the right chromatography resins and buffers, and optimize purification workflows. Learn strategies to overcome the challenges of purifying complex molecules and achieve target purity and yield, helping you speed new biopharmaceuticals to market more efficiently.

FOCUS ON FILL-FINISH

Challenges In Manufacturing TIL For Clinical Trials

Tumor-infiltrating lymphocyte cell therapy shows promise for treating solid tumors, but its complex manufacturing profile brings a unique set of issues. Here are some things to watch out for.

Vial Fogging: Practical Considerations For Vial Selection

Vial fogging is a common phenomenon observed in lyophilized biologic drug products. Examine two case studies that explore critical factors contributing to vial fogging and inform vial selection decisions.

Gain Speed To GMP Filling

Discover the advantages of a filling technology that provides faster readiness to good manufacturing practices (GMP) filling compared with traditional options.

FILL-FINISH SOLUTIONS

Automate Your Fill and Finish Process for Precision - Terumo BCT

DeltaCube™ Modeling Platform - West Pharmaceutical Services, Inc.

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Multispecific molecules bring added complexity to downstream purification—think incorrect chain pairings, aggregation, fragmentation, and lower yields. Join Bioprocess Online Live as we explore how developers are addressing these challenges to achieve high purity and efficient processes. Gain insights into key considerations for downstream teams when designing purification strategies for these advanced biologics. Registration is free thanks to the support of Thermo Fisher Scientific.

FOCUS ON DOWNSTREAM MANUFACTURING

Guide To PUPSIT And Annex 1 In Aseptic Processing

Pre-use, post-sterilization integrity testing (PUPSIT) ensures filters remain undamaged and effective during aseptic manufacturing. Discover how you can successfully perform PUPSIT with proven solutions.

Novel Approaches To Virus Filtration In Continuous Processing

Watch to explore two novel approaches that have been developed to overcome the limitation of a filter's viral retention performance in continuous processes.

3 Keys To Rare Disease Clinical, Commercial Drug Product Manufacturing

The complex biology of rare diseases creates unique hurdles, making it difficult to design and implement a drug development program. Explore the unique considerations for drug product manufacturing.

The Oligonucleotide Purification And Concentration Checklist

As the demand for oligonucleotides (oligos) increases in research, therapeutics, and drug development, so does the need for advanced technologies to enhance oligo manufacturing workflows.

Overcoming Bispecific Antibody Purification Challenges

Enhance the quality and safety of your BsAb therapeutics with a highly efficient with the right chromatography hydroxyapatite media.

Characterization Of A Therapeutic mAb, Antigen-Binding Fragments

Size homogeneity of a mAb in solution is crucial for comparability and characterization. Here, an IgG1 antibody was cleaved into antigen-binding fragments via pepsin and papain digestion, then purified.

Optimizing Monoclonal Antibody Manufacturing For Commercial Success

Strategically optimize your upstream and downstream processes and decrease the timeline from optimization to commercial manufacturing.

DOWNSTREAM MANUFACTURING SOLUTIONS

A Semi-Automated Tangential Flow Filtration System - Cytiva

Address Modern mAb Purification Challenges - Ecolab, Purolite Resins

Antibody Drug Conjugates: Link Your Antibody To Its Fullest Potential - Samsung Biologics

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