Newsletter | July 6, 2026

07.06.26 -- Overcoming The Hurdles Of Cell And Gene Therapy Commercialization

SPONSOR

Webinar: When High-Stakes ADC Decisions Can't Wait for More Material or Better Data

Learn how a streamlined analytical workflow can simplify early ADC development by enabling accurate concentration and drug-to-antibody ratio (DAR) measurements with minimal material. This webinar explores combining LC-MRM with a single UV280 measurement to eliminate separate calibration assays, establish reusable linker-payload extinction coefficients, and support faster, more confident ADC candidate selection and characterization. Click here to learn more.

INDUSTRY INSIGHTS

Scaling For The GLP-1 Revolution: Meeting Global Injectable Demand

To keep pace with surging GLP-1 demand, pharma needs partners that can rapidly scale injectable production while maintaining flexibility, quality, and regulatory rigor.

Unlock The Potential Of Accelerating Your HEK Cell Line Development

Discover how an advanced cell line development platform now supports HEK cells alongside CHO, enabling rapid, scalable production of biologics while saving up to 12 weeks on development timelines.

Efficient Late-Stage Development Of Biologics

Reducing biologics costs requires strategic late-stage process development, yield optimization, scale-up, and raw material substitution—all while maintaining product quality and compliance.

FEATURED EDITORIAL

Overcoming The Hurdles Of Cell And Gene Therapy Commercialization

From impurity control to technology transfer governance, these practical lessons will help sponsors navigate the realities of oligonucleotide manufacturing scale-up.

Achieving Annex 1 Compliance In Sterile Manufacturing, Part 1: Common Compliance Failures

A persistent gap remains between what Annex 1 requires and what facilities can demonstrate. Let's take a closer look at four common compliance failures.

INDUSTRY INSIGHTS CONTINUED

A Smart, Data-Driven Approach To Formulate Biotherapeutics For PFS

Explore a unique model to predict injection force designed to decorrelate factors linked to formulation development and the ones linked to container and delivery device selection.

How To Maximize Pipeline Value And Enhance eNPV

Find out how reducing vendor fragmentation can improve program continuity, minimize delays, and support more predictable development outcomes.

Covalent Warhead Reactivity: A New Look At GSH Reactivity Assays

Understanding covalent warhead kinetics is key to reducing safety risks early in discovery. Learn about a new approach to GSH‑based measurements that offers clearer predictors of toxicity.

How CDMOs Adapt: Differentiators, Competencies, Prioritizing Quality

Modern drug manufacturing requires a shift toward partnerships that prioritize agility and quality. Success depends on specialized expertise and technical collaboration to navigate requirements.

The Fill/Finish Timeline: What Comes After Manufacturing

The post-manufacturing backend of sterile injectable fill-finish operates in a strict sequence—encompassing inspection, testing, QA review, and complex labeling validation—requiring early planning.

Science With Purpose: Advancing Sustainability In Biopharma Testing

Assimilate how biopharma labs are cutting animal use, energy, and paper waste while maintaining GMP compliance — with specific data on 85% labor reductions and 1 ton of CO2e saved annually.

Every Milliliter Matters: Maximizing Yield In Fill-Finish

A technical overview of minimizing product loss in aseptic fill‑finish processes, highlighting key loss points and practical strategies to improve yield, efficiency, and manufacturing consistency.

Biosimilars – From An Executive Perspective

An experienced industry leader shares insights on how biosimilars are reshaping healthcare through scale, manufacturing discipline, supply reliability, and long‑term commercial strategy.

Improvements In ADC Efficacy And Stability

Antibody–drug conjugates link antibodies to potent toxins, but increased hydrophobicity impairs stability, manufacturing, and PK, spurring interest in hydrophilic linker strategies.

Antibody-Based Drug Discovery At The Speed Of Light

Review this end-to-end workflow, including First-to-Human antibody development strategies, the use of this platform for targeted immunization, and the precision of single B cell screening.

SOLUTIONS

Expanding Manufacturing Horizons For Complex Large Molecules

Integrated Antibody‑Drug Conjugate Development And Manufacturing

Bioprocess Training And Education

Meet The Demands Of Today To Help Ensure The Possibility Of Tomorrow

Streamline Your Quality Release Processes

Mammalian Protein Development And Manufacturing

OUTSOURCED PHARMA CAPABILITIES UPDATE

Find Your New CDMO At Outsourced Pharma Capabilities Update

CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capabilities. See for yourself why this virtual event has become a wildly popular resource to identify options for your development and manufacturing needs.

Connect With Outsourced Pharma: