Newsletter | August 31, 2026

08.31.26 -- For Bispecific Ab Programs, Measure Twice And Outsource Once

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Webinar: Before IND Know: How To Overcome Early Development Challenges Before They Impact Your Program

Move your biologic candidate toward the clinic with greater confidence. Join Lonza’s Dr. Yvette Stallwood as she shares real-world case studies demonstrating how early developability insights can resolve manufacturability, quality, expression, and immunogenicity challenges. Learn practical strategies to strengthen candidate selection, reduce development risk, improve readiness for IND-enabling activities, and accelerate clinical development success. Click here to learn more.

INDUSTRY INSIGHTS

 

Unlocking Efficiency In Large-Scale Microbial Manufacturing

Webinar | Lonza

Gain insights into how expert teams and the right tools help build resilience into manufacturing systems and tackle small, often-overlooked issues before they become costly problems.

 

De-Risking Drug Development: Informatics-Supported Solid Form Selection

Application Note | Ardena

Learn how combining polymorph screening with structural informatics improves solid‑form selection, lowers development risk, and boosts confidence in long‑term stability and manufacturability.

 

AI Predictive Maintenance Prevents Batch Loss And Production Shutdown

Case Study | Jubilant HollisterStier

AI-powered predictive maintenance with wireless vibration sensors prevented costly batch loss and production shutdowns in manufacturing by fixing equipment issues before failures occurred.

FEATURED EDITORIAL

For Bispecific Ab Programs, Measure Twice And Outsource Once

By Jeffrey S. Buguliskis, Ph.D., deputy chief editor, Outsourced Pharma

Just like inspecting a house before a major renovation, biopharmas must address underlying bispecific structural and analytical flaws before handing their molecule off to a CDMO.

 

The Complex Anatomy Of An ADC Tech Transfer

By Ivan Di Bonaventura

Unlike traditional biologics tech transfer, antibody-drug conjugates have many more moving parts. Here are some of the unique challenges that require close attention.

INDUSTRY INSIGHTS CONTINUED

 

Key Changes And Their Impact On Biological Reactivity Testing

Article | By Jillian Miller, Pace® Life Sciences

USP <86> introduces validated recombinant alternatives for endotoxin testing, supporting animal-free QC. Uncover key validation, comparability, and regulatory considerations.

 

Reducing The Bioburden Load In Downstream Bio Pharmaceutical Processes

Application Note | Critical Process Filtration

Layered microorganism removal prevents fouling, minimizes disruptions, and maintains product quality in demanding biopharma environments.

 

Real-Time Analytics And Predictive Control In Biomanufacturing

White Paper | By Jihye Heo and Jinhyoung Lee, Samsung Biologics

Advanced analytics, predictive modeling, explainable AI, and digital twins are helping biomanufacturers improve process visibility, anticipate outcomes, and support smarter operational decisions.

 

The Fill/Finish Timeline: What Comes After Manufacturing

Article | Afton Scientific

The post-manufacturing backend of injectable fill/finish operates in a strict sequence — encompassing inspection, testing, QA review, and labeling validation — requiring planning to avoid delays.

 

The Strategic Benefits Of Isolator Lines In Manufacturing

Article | IDT Biologika

Discover how high-speed isolator lines enable sterile, scalable manufacturing for complex biologics and injectables with unmatched efficiency and product integrity.

 

5 Ways Pre-Filled Syringes Contribute To Better Patient Outcomes

Article | Curia

In our series on pre-filled syringes, we explore five key ways this delivery format is enhancing patient outcomes, not just through the medicine it contains, but through the device design itself.

 

Should Platform Biotech Companies Partner, Sell, Or License?

Article | BioBridge

Platform biotech companies face critical choices on partnering, licensing, or selling technology—decisions that shape focus, valuation, and long‑term success beyond scientific innovation alone.

 

Rapid, Reliable Technology Transfer

Article | WuXi Biologics

See how structured planning, expert coordination, and risk‑focused execution speed tech transfer, improve consistency, and move biologics into manufacturing faster.

SPONSOR

 

Webinar: Optimizing Peptide Production With PUREcoli™: A Smarter Microbial Approach To Therapeutic Peptide Manufacturing

Therapeutic peptide demand is surging, but traditional synthesis brings cost, scalability, and sustainability challenges. Explore how microbial expression using KBI Biopharma’s PUREplatform™ and PUREcoli™ technology can enable more efficient peptide manufacturing. Using liraglutide as a case study, discover practical strategies to improve yields, reduce costs, and streamline downstream processing for scalable, commercially ready production. Click here to learn more.

SOLUTIONS

Stable Cell Line Development For Complex Biologics

Catalent

Your Partner For Vital Injectable Products

Simtra BioPharma Solutions

Aseptic Fill/Finish

Kindeva

Microbial Services: Protein Manufacturing

53Biologics

Helping Enhance Yield And Purity Of mAb Capture And Polish Resins

Thermo Fisher Scientific Bioproduction

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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