Newsletter | September 3, 2026

09.03.26 -- CDMO Selection For Small Biotech: Amit Jain On Avoiding Costly Transfers

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Webinar: Breaking the Concentration Barrier: New Long - Term Stability and PK Data for Subcutaneous Nanotrastuzumab

High-dose biologics can make SubQ delivery challenging due to viscosity, stability, and injection volume limitations. Discover how Nanoform’s nanoparticle engineering technology enabled an ultra-high concentration trastuzumab suspension at 440 mg/mL, delivering 75% lower injection volume and promising stability and pharmacokinetic performance. Explore the potential for more patient-centric, low-volume SubQ therapies.

INDUSTRY INSIGHTS

 

Assessing Production And Stability Of Antibody Drug Conjugate Platforms

ADCs with similar antibody sequences can behave differently due to linker and payload choices. Analytical tools reveal structural and stability differences critical to therapeutic performance.

 

4 Reasons For The Rise In Blister Packaging

Here are the factors that are driving blister to the forefront of pharmaceutical packaging, and at an even faster rate than its current growth.

 

Navigating The Challenges Of AI/ML In R&D

AI progress is stalled by fragmented, low-quality data, not technology. Standardization, automation, and cultural change transform disconnected datasets into a foundation for smarter decisions.

FEATURED EDITORIAL

CDMO Selection For Small Biotech: Amit Jain On Avoiding Costly Transfers

Make smarter outsourcing decisions early. Reduce the risk of costly tech transfers, evaluate capacity needs, speed development timelines, and strengthen manufacturing partnerships.

 

INDUSTRY INSIGHTS CONTINUED

 

What Is LearnGxP?

Stop the cycle of "click-through coma" in GXP training. Discover how scenario-based learning and role-specific curricula reduce compliance risks and drive meaningful engagement.

 

Oral Delivery Of PROTACs: Integrating Molecular Design

Explore how integrated molecular design and formulation strategies can overcome the unique oral-delivery challenges of PROTACs, transforming complex degraders into viable, scalable medicines.

 

Advanced Analytical Tools To De-Risk Pharmaceutical Development

Discover three tools that facilitate a successful journey from candidate compound to clinical triumph: solid form screening, PBPK modeling, and AI-enabled route scouting.

 

Pioneering RTU Flexibility With Robotic Fill-Finish Systems

Modernize sterile manufacturing with robotic fill-finish systems. Achieve multi-format flexibility and risk reduction to meet the rigorous demands of personalized medicine and small-batch production.

 

Improving Next-Generation Sequencing Workflows With Droplet Digital PCR

Optimize NGS workflows by using digital PCR for absolute quantification. Improve library quality, reduce bias, and gain sensitive validation for rare variants in complex genomic samples.

 

Navigating Complex OSD Challenges With Predictive Insights

Examine how predictive modeling, advanced material characterization, and data-driven process insights support manufacturing readiness and confident launch decisions.

 

The Route To Faster Microbial Quality Control

Join product and application experts Anne-Grit Klees, Carine Krebs, and Esther Welterlin to uncover the benefits of using a new rapid microbial detection platform.

 

Sticky Situations: Tackling Residue Inside The Cleanroom With Dave Nobile

See how to effectively manage chemical residue buildup in cleanrooms through proper solvent selection, dwell time, and mechanical removal to support regulatory compliance.

 

From Molecule To Milestone: Fast Track Formulation

Fast‑track, data‑driven formulation strategies align early decisions with long‑term goals, enabling First‑in‑Human progress while reducing risk and avoiding rework.

 

cGMP Vs GMP In Cleanrooms: Understanding The Differences That Matter

Differentiating GMP from cGMP helps facility teams design cleanrooms that meet modern contamination controls, process flows, and regulatory standards.

 

Leveraging Autoinjector Innovation To De-Risk Biosimilar Development

Gain insight into how a biopharmaceutical company can de-risk the launch process by choosing a suitable autoinjector technology and partner.

 

Managing Risk In The Most Complex Combination Device Format

Autoinjectors add mechanical forces and interactions that change how container closure integrity must be evaluated. Learn why device complexity creates new risks and how testing strategies must adapt.

 

Small Molecule Orphan Drugs: Status Quo, Challenges, And Perspectives

By establishing robust manufacturing processes and scalable production strategies from the outset, developers can help de-risk orphan drug production, improve efficiency, and more.

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Webinar: How to Achieve Stable, High-Output Stickpack Production

Process complexity, not machine speed, is often the biggest barrier to efficient stickpack production. Join this webinar to learn how integrated production strategies, precise dosing, automated quality control, and optimized material handling can improve OEE, reduce waste, simplify operations, and support future-ready pharmaceutical and nutraceutical manufacturing. Discover practical strategies to increase productivity, improve flexibility, and prepare operations for regulatory requirements. Click here to learn more.

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