Newsletter | May 5, 2026

05.05.26 -- U.S. Pharma Tariffs And MFN Become Law After April 2 Update

SPONSOR

Webinar: Design scalable downstream processes with practical purification and analytical strategies

Explore how to build robust, scalable downstream purification processes across today's complex modalities. In this Cytiva webinar, experts share practical chromatography strategies, advanced analytical insights using SPR and SEC-MALS, and real-world case examples to help reduce risk, solve impurity challenges, accelerate development, and strengthen long-term internal process knowledge and operational efficiency from proof of concept through scale-up. Click here to learn more.

FOCUS ON OUTSOURCING

U.S. Pharma Tariffs And MFN Become Law After April 2 Update

Beginning July 31, 2026, a U.S. pharmaceutical tariff will apply to patented products and their APIs, beginning with large companies. Beroe Inc.'s Mathini Ilancheran breaks down the tariff's impact, explores its risks, and proposes five procurement strategies to addressing them.

Driving Operational Excellence Using Machine Learning

Explore how advanced machine learning and data analytics are revolutionizing biopharmaceutical manufacturing and driving operational excellence.

Linker Design Approaches To Improve ADC Stability And Activity

ADC design choices shape efficacy and selectivity. Hydrophilic modifications are evaluated for their effects on cytotoxic activity, target specificity, and cell viability across multiple tumor models.

Realizing The Potential Of The Evolving CDMO Ecosystem

Pharma is shifting to integrated manufacturing partners to handle complex drugs. Technical synergy and global alignment boost resilience and speed patient access.

How Reshoring, GLP-1s, And Supply Chain Security Are Transforming CDMOs

Assimilate how reshoring, GLP-1 capacity demands, and integrated U.S.-based manufacturing models are reshaping CDMO partnerships in a rapidly evolving pharmaceutical market.

Benefits Of Isolator Technology In Fill-Finish

Isolator technology enhances sterility assurance, reduces contamination risk, improves operator safety, and supports regulatory compliance, making it essential for modern aseptic fill-finish operations.

Securing A Treatment Through Grit And Collaboration

Discover how one family defied the odds — bringing a lifesaving gene therapy from idea to treatment in just 14 months after a devastating rare disease diagnosis.

Smart Cell & Gene Feasibility For Clinical Success

Delve into why investing in a comprehensive feasibility program for GOI testing is not just beneficial, but absolutely essential for cell and gene therapy companies.

Digging Into Manufacturing Priorities For Viral Vectors

Addressing the complexities of viral vector manufacturing through strategic internalization, advanced technologies, and regulatory excellence is crucial for the future of gene therapies.

Why Cell And Gene CDMOs Benefit From Digitalization

Get to know why digitization is crucial for cell and gene contract manufacturers by learning the various benefits digital transformation can offer such as efficiency, compliance, and innovation.

ICP-MS And ICP-OES: Tools For Elemental Impurity Analysis

Leverage advanced elemental impurity testing methods to ensure the safety, compliance, and accuracy of your drug products throughout the manufacturing process.

Microbial Biomanufacturing: Where We've Been And Where We Are Going

Learn more about the cutting-edge technologies driving the shift to microbial expression and how the right outsourcing partner can help you leverage the benefits of these innovative therapeutics.

The Next Frontier In mRNA: Modular Manufacturing For RNA-LNP Therapies

Unlock the design of a modular GMP manufacturing facility for RNA-LNP to support long-term, scalable therapy development.

OUTSOURCING SOLUTIONS

Strengthening Fill–Finish For Biologics - Argonaut Manufacturing Services

Fill & Finish Services - 53Biologics

Non‑Animal Pyrogen Detection With MAT - SGS

Updated Large‑Molecule Manufacturing - Abzena

Master And Working Cell Banks, 24/7 Monitoring - Applied StemCell

Integrated ADC Offering: From Concept To Commercialization - Lonza

SPONSOR

Webinar: Strategic Early Material Generation for Accelerated Process Development

Accelerating access to early-stage material is critical for efficient biologics development. In this webinar, Samsung Biologics shares its integrated approach to early material generation, aligning with cell line development to deliver scalable, production-relevant material faster. Learn how this strategy supports developability assessment, reduces variability, and enables efficient downstream activities, with case studies demonstrating improved timelines, resource use, and overall program success. Click here to learn more.

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