Newsletter | August 11, 2025

08.11.25 -- AI Meets CDMO: Smarter Outsourcing For Biologics And Cell And Gene Therapies

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

The Value Of Tailoring Transposons For Optimized Biotherapeutic Production

By leveraging technologies together with transposon design to achieve semi-targeted integration, drug developers can achieve more efficient and consistent production.

Cost-Effective Strategies For Sterile Injectable Outsourcing

Explore how CMOs are playing a pivotal role in enabling pharmaceutical companies to optimize their operations and how this collaboration is reshaping the future of pharmaceutical manufacturing.

Characterizing The Effector Functions Of Therapeutic Antibodies

Gain a thorough understanding of the Fc region of your antibody product and how to use a risk-based approach to strategically test its functionality, efficacy, and development.

FEATURED EDITORIAL

AI Meets CDMO: Smarter Outsourcing For Biologics And Cell And Gene Therapies

Vadim Klyushnichenko, Outsourced Pharma Board member and VP at California Institute for Biomedical Research (Calibr), continues his detailed discussion of utilizing AI at CDMOs to improve the outcomes for both sponsors and external service providers.

Billions Of Dollars In CDMO Secondary Packaging Of Biologics

Chief Editor Louis Garguilo analyzes a report projecting the biologics CDMO secondary packaging market could rise from $2.59 billion this year to USD $5.50 billion by 2034. Projecting so far into the future is tricky business, but Garguilo explains the ultimate value.

INDUSTRY INSIGHTS CONTINUED

Managing Solubility With Cutting-Edge Formulation Approaches

An increasing number of poorly soluble APIs are the cornerstone of cutting-edge therapies, necessitating equally complex formulation technologies to maintain or improve solubility and, ultimately, bioavailability.

Keys To Rare Disease Clinical, Commercial Drug Product Manufacturing

Examine the unique considerations for rare diseases that create hurdles, making it difficult to design and implement a drug development program.

Stopper Migration In Frozen Pre-Filled Syringes

Review a semi-automated method for dynamically assessing plunger migration under controlled variations in temperature and pressure, utilizing computer vision tools.

Small Is Powerful And Sustained

Advances in release drug delivery could improve efficiency and consistency in drug release, manifesting real-life advantages for patients in the form of enhanced accessibility and compliance.

Set Up And Qualify GMP Laboratories

Observe an established and qualified GMP microbiology lab in Ireland, providing expertise, staffing, training, and project management to ensure compliant operations and client success.

A Deep Dive Into Expression Approaches For Biotherapeutics

Whether you’re at the discovery stage or thinking about commercial production, gain useful insights on expression formats from transient transfection, through stable pools to stable clones.

Characterization Of A Therapeutic mAb, Associated Antigen-Binding Fragments

Size homogeneity of a mAb in solution is crucial for comparability and characterization. Here, an IgG1 antibody was cleaved into antigen-binding fragments via pepsin and papain digestion, then purified.

From Knowledge Management To Learning Empowerment: Talent Development

Uncover how to transform biopharma learning with a human-centered, AI-enhanced ecosystem that personalizes development, fosters engagement, and aligns training with real-world impact.

SOLUTIONS

Drug Characterization And Release Testing Services

Learn how leveraging the expertise and flexibility of a partner empowers you to ensure regulatory compliance from the outset, with thorough characterization starting at the earliest stages.

Partnering For Manufacturing Success

Our multi-product facilities feature state-of-the-art equipment for animal cell-derived viral and microbial products for your clinical trials in phase 1-2.

Capacity Update January 2025: Fill/Finish

Discover how our end-to-end Drug Product capabilities support the full lifecycle of biologics, seamlessly integrated with our extensive drug substance network across diverse modalities.

Dream Plant: Within Your Reach. Built For Your Success.

As pressure to accelerate timelines mounts, finding a CDMO committed to optimizing processes with innovative technologies is key for adding efficiency while maintaining high quality standards.

Scalable Solutions From Clinical To Commercial Production

Our 87,000 sq. ft. cGMP-certified drug product manufacturing facility, located in Baltimore, Maryland, offers aseptic fill/finish manufacturing of biologics and sterile injectables.

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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