Newsletter | December 18, 2025

12.18.25 -- The Top 10 Nations Redrawing The Outsourcing Map

INDUSTRY INSIGHTS

Shifting Drug Development With Advanced Analytical Characterization

Explore the advancing mass spectrometry, biophysical characterization, automated sample preparation, and high throughput analytics required to deliver medicines in a safe, compliant, and efficient manner.

What Can You Do To Improve Your ADC's Chance Of Clinical Success?

Improving your ADC’s chance of clinical success requires an understanding of what potential obstacles lie ahead and what capabilities and expertise are necessary to overcome them.

Navigating OOX Results: Effective Analysis, Management In CDMO Labs

By prioritizing the management of Out of Expectation (OOX) results within your CDMO laboratory, learn how you can ensure product integrity, patient safety, and unwavering regulatory compliance.

FEATURED EDITORIAL

The Top 10 Nations Redrawing The Outsourcing Map

There was a time when outsourcing strategies could be managed with a simple spreadsheet and a focus on cost-per-liter. Those days are gone…

The Future Of Biotech Outsourcing: Essential Skills For Program Managers

The next generation of program managers who liaise with contract manufacturers will require an expanded, adaptable skill set to thrive in an increasingly complex environment.

INDUSTRY INSIGHTS CONTINUED

Controlled Nucleation Offers Homogeneity And Batch Consistency

Controlled nucleation standardizes freezing across all vials, leading to uniform ice crystals and improved lyo cake quality. This critical step reduces variability and supports robust product scale-up.

Quality And Regulatory Compliance In Fill-Finish

This resource provides a clear roadmap for delivering advanced sterile injectable therapies with confidence, meeting both regulatory demands and patient needs without compromise.

A Guide To Optimize Analytical Strategies Throughout Biologics Development

A miscalculated analytical approach can be costly to develop, perform, and maintain. Many organizations also lack appropriate resources to create optimal testing methods and protocols.

De-Risking FDA Abbreviated New Drug Application (ANDA) Submissions

BD’s Vystra™ Disposable Pen for Liraglutide 3.0 mg demonstrated comparable usability to the reference device, helping de-risk ANDA submissions through proactive human factors evaluation.

Fixtures And Surrogates For Combination Product Performance Testing

The combination product market is consistently expanding. Transitioning from traditional vial systems to needle-based combination products presents several challenges that require careful consideration.

How To Minimize API Loss: An Aseptic Fill/Finish Study

With active pharmaceutical ingredient (API) values continuing to climb as production scales conversely drop, it is time to rethink our aseptic filling processes to minimize API loss.

Seamless Onshoring From China-Based CDMO

See how a large-scale manufacturing process was rapidly requalified in eight months to secure a clinical-stage biologic program by mitigating geopolitical risk and maintaining supply continuity.

Transforming Data Into Knowledge Throughout The Product Lifecycle

The following process characterization services are based on QbD principles, with an emphasis on risk and knowledge management and transforming data into the currency of product and process.

SOLUTIONS

Capabilities Update October 2025: Large Molecule

Accelerate your therapeutic antibody and complex protein development with advanced mammalian cell line platforms that move from DNA to RCB in just 10 weeks.

Recombinant Protein Process Development And Scale-Up

Uncover a resin for recombinant protein purification with a standardized protocol that streamlines workflows from lab to production, which saves time and enhances efficiency across development stages.

Capabilities Update January 2025: Fill/Finish

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

Trusted End-To-End CDMO Partner For Your Journey

Partner with a trusted, globally proven CDMO whose world-class, rapidly scalable facilities and unwavering commitment to quality help accelerate patient access to life-saving biologics.

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.

Connect With Outsourced Pharma: