Newsletter | January 27, 2026

01.27.26 -- A Deeper Look At Pharma's Structural Supply Chain Vulnerability

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Join Bioprocess Online Chief Editor Tyler Menichiello on February 11, at 11 a.m. Eastern, for an interactive panel discussion exploring how upstream and downstream development teams can work together to reduce risk, accelerate process scaling, and support smoother downstream tech transfer. Register for free thanks to support from Ecolab.

FOCUS ON OUTSOURCING

A Deeper Look At Pharma's Structural Supply Chain Vulnerability

Fixing limited capacity in pharmaceutical CMC development starts with understanding a complex web of root causes.

Friendshoring: A Strategic Shift In Pharma Supply Chains

To safeguard the consistent delivery of essential therapies to patients around the world, biopharmaceutical companies, alongside their CDMO partners, are rethinking traditional supply models.

Facility-Fit-Driven Process Development For A Monoclonal Antibody

See how proactively designing around plant constraints, using high-capacity resins, and leveraging parallel workstreams resulted in a 50% reduction in processing hours and 25% lower costs.

Simulated Control Strategy For Product Diversion Management

Consider this manufacturing platform integrating perfusion bioreactors, continuous product capture, low pH viral inactivation, polishing, viral filtration, and formulation steps.

Complexing RNPs: Have You Established Your Clinical Acceptance Criteria?

When using CRISPR-Cas proteins for gene editing, it’s critical to ensure consistency and quality. The FDA recommends establishing well-defined acceptance criteria for the RNP formation step.

CDMO Media And Buffer Outsourcing: A Strategic Advantage

Learn how outsourcing cell culture media and buffers removes bottlenecks, freeing specialized CDMO resources. Ensure consistency, accelerate timelines, and streamline GMP readiness for client success.

Controlled Nucleation Offers Homogeneity And Batch Consistency

Controlled nucleation standardizes freezing across all vials, leading to uniform ice crystals and improved lyo cake quality. This critical step reduces variability and supports robust product scale-up.

Non-Viral And Large-Scale Delivery Of Gene Editing Tools

Explore an advanced electroporation platform that enables reliable, large-scale, non-viral delivery of complex gene editing tools like CRISPR/Cas9 for T-cell manufacturing.

Unlock Robust And Reliable Stability Data With The Right Partner

Stability testing is essential to ensuring your drug’s stability, potency, efficacy, and safety under different controlled conditions throughout development, manufacturing, and life cycle management.

Tech Transfer In Sterile Injectables: 3 Phases Of Success

Examine the 3 phases of sterile injectable project tech transfer, including how to bridge information gaps and facilitate successful regulatory filing at this fundamental stage of drug development.

Framework To Deliver Standardized, Reliable Biomanufacturing Facilities

Standardized, continuously optimized facility design enables scalable and reliable biomanufacturing that improves quality, accelerates timelines, and ensures consistent performance across sites.

OUTSOURCING SOLUTIONS

Integrated ADC Offering: From Concept To Commercialization - Lonza

Mammalian Protein Development And Manufacturing - Avid Bioservices

Advancing Vaccines From Preclinical Development To Commercial Supply - FUJIFILM Biotechnologies

An Optimized Solution For Rapid Transient Expression - Lonza

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