Newsletter | August 14, 2025

08.14.25 -- Our Supplier Failed? Heck No, We Failed Our Supplier!

SPONSOR

Webinar: Closing the Scale-Up Gap: N-1 Perfusion Strategies for Commercial-Ready Biologics

Ready to scale smarter? Join Boehringer Ingelheim’s webinar to discover how modular N‑1 perfusion transforms upstream biologics manufacturing—boosting inoculum density, speeding up seed trains, and easing facility strain. Learn how to bridge the scale-up gap and future-proof your process for commercial success. Don’t miss out—register now to reserve your spot! Click here to learn more.

INDUSTRY INSIGHTS

Can Your Facility Cleaning And Disinfection Process Pass Regulatory Scrutiny

Explore strategies to meet regulatory standards, emphasizing planning, stakeholder involvement, testing, trending, documentation, and continuous improvement.

Navigating The New USP Chapter For Elastomeric Closures

Learn about new required tests and instrumentation for compliance and recommendations on method implementation.

How Fast-Track Strategies Accelerate Time-To-Clinic

Delve into how biopharmaceutical sponsors can minimize timelines by using innovative development strategies that trade potentially increased risk for time savings.

FEATURED EDITORIAL

Our Supplier Failed? Heck No, We Failed Our Supplier!

“We would be in meetings, and someone would disparage a certain CDMO. But one of our leaders would almost always have the opinion that we could make the relationship work. ‘No one is perfect, including us,’ he said.” Outsourcing is an attitude, explains Dan Marasco. Here's the attitude he says you should bring to your external partnerships.

How Much Knowledge Work Can Biopharma Offload To AI? Answer: Not Much

In biomanufacturing, knowledge work and manual work are deeply intertwined. One expert suggests replacing entire workflows with artificial intelligence seems unlikely.

INDUSTRY INSIGHTS CONTINUED

The Art And Science Of Topical Formulations

Chief Scientific Officer Jon Lenn discusses the balance in topical formulation development, emphasizing advanced skin models for optimized delivery, activity, and product stability.

Leveraging High-Pressure Sterile Filtration For Highly Viscous Solutions

This research demonstrates the potential of high-pressure sterile filtration to enhance efficiency, reduce waste, and accelerate the development of innovative therapies.

The CMC Regulatory Landscape During Product Development, Manufacturing

Through case studies and practical insights spanning complex drug substances and drug products like ADCs, learn more about navigating complexities with strategic guidance.

Protein Manufacturing Utilizing A Titerless Baculovirus Platform

Examine how an innovative platform accelerates protein manufacturing with enhanced scalability, reproducibility, and long-term virus stability for cutting-edge biologics production.

Shaping Biotherapeutic Programs Around Different CMC Paths

As protein engineering and manufacturing technologies evolve, there's a need for flexible, customized strategies to accelerate drug development and approval of biotherapeutics.

Strategic Biomanufacturing Partner For Multispecific Antibodies

A structured approach integrating technical expertise, advanced process solutions, and scalable, flexible infrastructure can address the unique challenges of multispecific antibody development.

Achieving Rapid, High-Titer Expression For Next-Generation Biologics

This advanced cell line development technology overcomes production challenges related to the expression and scalability of complex biologics.

Accelerated Peptide Drug Development And Clinical Strategies

Review how an integrated platform approach and innovative filtration helped bring a novel therapeutic to Phase 1 clinical trials with reduced time and costs.

SOLUTIONS

Analytical Considerations For Stability Testing, Characterization, Comparability

Develop a robust analytical strategy to ensure the quality and consistency of your antibody-drug conjugate by evaluating each component and navigating multi-site manufacturing complexities.

Advancing Your Molecule With Speed And Agility

We offer a comprehensive suite of bioanalytical and spatial biology solutions designed to support the progression of your molecule from discovery through clinical development and product approval.

Drug Substance Or API Manufacturing

Uncover our network's API capabilities, an innovative business model that does not add additional costs to your project. 

Cell Line Development Solutions

Discover technology that enables a cost-effective, easily implemented cell line development workflow while delivering high productivity pools and cell lines.

Microbial CDMO Services

Gain insight into one of our core areas of expertise, the development of large-scale processes for recombinant protein expression in microbial hosts (E.coli, P.pastoris, and S.cerevisiae).

OUTSOURCED PHARMA CAPACITY UPDATE

Find Your New CDMO At Outsourced Pharma Capacity Update

CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capacities. 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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