Newsletter | October 12, 2026

10.12.26 -- The Hidden Downstream Risks Of Upstream Process Decisions

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Webinar: Maintaining Process Consistency and Performance During N-1 Perfusion Scale-Up

Scaling an intensified N-1 perfusion process from bench to pilot scale can present challenges. Drawing on collaborative work conducted across 5 L, 50 L, and 500 L bioreactor scales, experts will share how consistent culture performance, cell growth, and monoclonal antibody production were maintained throughout scale-up. Gain practical insights into the key considerations, challenges, and strategies for successfully transferring intensified upstream processes toward larger-scale manufacturing.

FOCUS ON UPSTREAM MANUFACTURING

Upstream Decisions Influence Downstream Challenges

In this segment from the Bioprocess Online Live event, “The Levers And Tradeoffs That Drive Process Productivity,” panelists David Scherr, Ph.D. (AstraZeneca) and Vadim Klyushnichenko, Ph.D. (Calibr-Skaggs), answer the question, “What should developers be thinking about upstream to avoid downstream complications?” Klyushnichenko believes process-wide considerations like this begin earlier than cell line development at the product’s molecular construct itself.

 

 

CRISPR-Cas9 KO Cell Line Generation And Development

See how CRISPR-generated FKRP knockout muscle cells and a high-throughput On-Cell Western method can quantify α-dystroglycan glycosylation restoration and support rAAV-FKRP potency testing.

 

Towards A Universal LNP Platform For Multiplex Engineering

Multiplex engineering of T cells for solid tumors requires precise delivery. Emerging LNP approaches enable co-delivery of RNA and DNA, offering a safer, more scalable path beyond viral vectors.

 

Matrix Approach Enhances Potency Assay Development For ATMPs

Potency assays for ATMPs demand precision. Learn how a matrix approach, regulatory alignment, and advanced technologies can overcome variability and ensure safety throughout the product lifecycle.

 

Producing MSC-Derived Cell Therapies From Isolation To Large-Scale

Drive successful MSC therapy development by optimizing isolation methods, surface chemistry, and closed-system expansion technologies to ensure cellular stability and commercial scalability.

 

Why You Should Not Rely On Western Blotting For HCP Antibody Coverage

Legacy methods often mask critical impurities. Discover why traditional blotting may be jeopardizing your regulatory data and how to implement more sensitive, objective alternatives.

 

Moving Beyond Animal Models With iPSC-Based Models

Animal models are giving way to iPSC-based systems that better reflect human biology, offering researchers a more accurate and ethical path to drug discovery.

 

Automated Enrichment Of Human CD34+ Cells

Examine an automated strategy for enriching CD34+ cells, combining streamlined processing, strong purity and viability metrics, and reduced hands-on effort to support stem cell engineering.

 

Tuning Glycans For High Efficacy In Next-Gen Biologics

Discover how precise downstream glycan engineering addresses biopharma pain points, extending therapeutic half-life and ensuring absolute analytical similarity for biosimilars.

 

Licensed Vs. Unlicensed Cell Lines In Biologics Development

Choosing licensed vs. unlicensed cell lines impacts development speed, cost, flexibility, and long‑term control, making early strategic evaluation key to efficient biologics development.

 

Electroporation Enables Efficient Antibody Discovery By Mammalian Display

Achieve greater sequence diversity in antibody discovery. Learn about an approach that enables reproducible and scalable transfections, leading to the identification of better candidates.

 

Choosing The Most Effective Transfection Reagent For Your Needs

Choosing the right transfection reagent can be confusing. This guide explores product names, their applications, and the importance of testing beyond labeled uses.

UPSTREAM MANUFACTURING SOLUTIONS

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Large-Scale Cell Culture Multi-Product Facility - Boehringer Ingelheim Biopharmaceuticals GmbH

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Bending The AAV Manufacturing Cost Curve: Scalable Platform Innovation And Productivity Gains - Lonza

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CHO Residual DNA Quantitation - Thermo Fisher Scientific Bioproduction

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An IND-Approved Platform That Supports Diverse Molecules - Asimov

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Webinar: Scaling ADC manufacturing without compromising quality

Scaling ADC programs from clinical to commercial manufacturing brings new challenges in mixing, solvent distribution, hydrophobicity, and process control. This webinar explores practical strategies and digital tools to reduce scale-up risk, including CFD modeling for conjugation, membrane strategies for TFF, and SIMCA®-online for multivariate process control, batch genealogy, and golden batch monitoring. Discover approaches to improve consistency, robustness, and efficiency across ADC manufacturing. Click here to learn more.

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