10.07.25 -- On The Ground At BPI: Industry Reflections With Carl Schoellhammer, Ph.D.

For complex projects involving oral solid dosage (OSD) and sterile drug products, selecting the ideal CDMO can play a pivotal role in determining the success of a drug candidate.

Explore current and emerging technologies to optimize mRNA manufacturing, especially when considering commercial production and the validation of processes in a cGMP environment.

Single-use technologies (SUTs) bring speed and flexibility to modern biomanufacturing, but realizing their full value requires robust, stage-specific risk management to navigate material, supply chain, and regulatory challenges.

Ensure the potency and efficacy of your biologic products with a GMP-compliant potency bioassay, offering accurate real-time assessments for GMP release and stability testing.

Unlocking the potential of next-generation therapeutics requires extending the boundaries of both expression system technology and process development and manufacturing.

These real-world case studies highlight best practices and strategies to optimize bioconjugate drug product tech transfers and supplies in the clinical or commercial phase.

By forging strategic partnerships with comprehensive CDMOs, see how emerging biopharma firms can navigate through early-phase development and ensure a smooth transition to clinical advancement.

A CDMO’s manufacturing science and technology (MSAT) plays a critical role in optimizing a biomanufacturing process to meet the needs of the modern healthcare landscape.

High-quality process development aims to maintain a consistent process from toxicology through to GMP production runs, and can be aided by a capable, adaptable CDMO.

Advanced computational methods coupled with bioinformatics can be used to navigate the complexities of bioprocessing by anticipating challenges before they arise.

Explore the challenges when moving a bioconjugate candidate from early development to clinic, along with integrated solutions for navigating this growing area of the biopharmaceutical industry.