10.27.25 -- The Key To Outsourcing Is Timing, Not Timelines

Review the rapidly evolving world of complex drug development and the critical factors that drive success for products made using different molecules beyond the traditional antibodies.

The following studies offer a flexible, cost-effective way to interrogate process behaviors, optimize unit operations, and identify potential risks long before they impact full-scale production.

In developing a CDC assay for mAb characterization or QC release testing, in addition to selecting a target cell line, consideration should be given to the expression of CRPs on the cell surface.

Research suggests years-long stability studies that gobble up material can be reduced to a single day using milligram quantities.

Here, we review several challenges in biologics analysis and take a closer look at the advanced tools and methods being utilized to improve biophysical analysis reliability and efficiency.

Embrace the future of drug development by leveraging AI and innovative protein synthesis technologies to accelerate the creation of effective therapies and transform patient outcomes.

Proper formulation development has a huge impact on whether a technology transfer to the clinical phase fill/finish is successful. Consider the challenges of transitioning a promising drug candidate.

With the sector’s growth expected to continue — and sterile injectables increasingly pivotal in patient care — it is forecasted that the strategic value of outsourcing will only rise.

Uncover strategies to improve the performance of IB processes, as well as the pros and cons of soluble and insoluble processes: isolating, solubilizing, and properly refolding.

Learn how three companies collaborated to develop a new antibiotic to address the increasing development of antimicrobial resistance (AMR) that threatens the global health landscape.

Biopharmaceutical supply chain volatility is at an all-time high. To navigate this complexity, CDMOs must prioritize robust sourcing strategies and proactive vendor management.

This digital event features industry experts who will share best practices for streamlining processes between sponsors and CDMOs. Register today for free and you can walk away with actionable insights into aligning analytical methods and quality standards to accelerate small molecule production and reduce risk across the development lifecycle.

A stability program evaluates how pharmaceutical and biologic products maintain potency, purity, and quality over time, which ensures safety, effectiveness, and regulatory compliance.

Advance your clinical and commercial programs with expert aseptic fill finish and formulation services across vials, cartridges, and syringes, all in state-of-the-art, EU Annex 1-compliant facilities.

ArQ® - Bios offers a small, simple-to-use package to deliver high viscosity formulations in greater volumes than 1 ml, subject to matching the formulation characteristics with acceptable patient tolerability.

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