Newsletter | July 13, 2026

07.13.26 -- Evolving Relationship Structures For Reliable Drug Delivery

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

Tech Transfer Answers: How To Successfully Onshore A Mid-Phase Project

Onshoring biomanufacturing operations is an increasingly common decision. While a mid-phase tech transfer from international to domestic CDMO can be complex, the right partner can ensure success.

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.

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.

FEATURED EDITORIAL

The Compliance Roadmap: Minimizing Risk In Biologics Formulations

Any manufacturing process change for a biologic can raise comparability questions. Here’s a practical, action-oriented strategy to ensure health authorities are satisfied.

Evolving Relationship Structures For Reliable Drug Delivery

Manda Pasarkar, Global Regulatory Affairs, CMC Head, Sanofi, has overseen global, multi-billion-dollar portfolios of products from early development to commercialization. She spoke with Chief Editor Louis Garguilo on her outsourcing strategy and philosophy.

INDUSTRY INSIGHTS CONTINUED

Evaluating The Entire Package System Under USP 382

USP 382 introduces holistic packaging evaluation, focusing on container closure integrity, functionality, and real-world conditions to ensure sterility, safety, and product reliability.

Practical Considerations For Your Process Characterization Study

Outsourced process characterization can save time, but only with the right preparation. Clear expectations around materials and data interpretation help reduce rework and strengthen confidence.

What's The Real Challenge In Biologic Manufacturing Scale-up?

As you plan your next stage of scale-up, take a moment to evaluate whether your manufacturing strategy is built around capacity — or around evolving market demand.

Cracking Complexity: Learnings From 70+ Bispecific Antibody Programs

The goal is practical: help development teams make early decisions that balance speed, quality, and risk and support a smoother path to the clinic.

Optimizing Charge And N-glycan Profiles For CHO-Derived Fusion Proteins

Discover how structured design-of-experiment approaches can optimize charge variants and glycosylation to enhance biologics quality and therapeutic performance.

A New Look At Subcutaneous mAb Delivery Using Nanoformed Particles

A highly concentrated non-aqueous suspension of an IgG1 was developed using a patented platform. Review how the particle size of the mAb impacts the overall behavior of the drug product.

How To Value Automation With The Return On Invested Capital Model

Gain insight into the Return on Invested Capital (ROIC) advantages of an automated manufacturing facility and its correlation to the digital maturity of your operation.

Untapped Potential In Animal Health Innovation

Animal health innovation is driving rapid market growth, fueled by rising demand and complexity, creating opportunities for advanced therapies, sustainability, and better disease management.

5 Advantages Of Dual-Sourcing In Pharmaceutical Fill/Finish

Delve into the specific advantages of dual-sourcing in pharmaceutical fill/finish, exploring how this approach can bolster supply chain resilience, increase capacity, and accelerate commercialization.

How Characterization Analytics Smooths The Path To IND

Smart analytical decisions made early can prevent costly issues later. Real-world examples show how right-sized analytics enable smoother scale-up and fewer late-stage surprises.

SOLUTIONS

Predictive Precision: Eliminating Variability In Bioprocess Delivery

Strategic Insights For Reliable Large-Molecule Commercial Pathways

From Vision To Vial

Streamlining Predictability Across Mammalian and Microbial Platforms

Maximizing Filling Flexibility And Annex 1 Compliance For Sterile Injectables

A Fully Integrated Toolbox For Therapeutic Protein Expression

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.

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