07.10.25 -- Outsourcing Biologics Comes With "Demands"

20-minute capacity and capabilities quick-looks, 20+ brand new CDMO presenters to evaluate for best-fit this quarter – and a (virtual) commitment of less than 20 percent of your day? We're confident you don’t need 20/20 vision to see the value in this! Join us for Outsourced Pharma's July Partner Week – including sessions in Small Molecule API/HPAPI, Small Molecule Finished Dosage Form, ADC, Analytical Services, and Fill/Finish among others. Registration, on-demand access, and interactive Q&A are free.

CMOs play a critical role in regulatory compliance for parenteral manufacturing, using audits, quality systems, and proactive strategies to ensure product safety and patient well-being.

Numerous factors impact a drug safety program, but proper management of three key elements drives success while creating a scalable drug safety model.

Can high flow rates and turbulent conditions compromise protein quality? This analysis explores the relationship between fluid dynamics and aggregation in membrane and resin chromatography systems.

Some drugs violate multiple Ro5 elements but remain developable, while some molecules adhere strictly to the Ro5, but their properties are not conducive to development.

Dileep Boinipally has extensive experience in formulation, manufacturing process development, and regulatory strategy. He’s adept at explaining all that, but Chief Editor Louis Garguilo got him to focus for readers on the ins-and-outs of the practice of early formulation development.

Annex 1 sets EU regulatory standards for sterile manufacturing, which emphasize contamination control, quality management, and risk prevention to enhance patient safety and regulatory compliance globally.

Explore innovative process and facility models that optimize efficiency, sustainability, and cost-effectiveness in biopharmaceutical manufacturing.

A highly concentrated non-aqueous suspension of an IgG1 was developed using a patented platform. Review how the particle size of the monoclonal antibody (mAb) impacts the overall behavior of the drug product.

Identifying manufacturing capacity that can adapt to a growing and changing biopharma landscape requires an emphasis on technical and operational expertise combined with agility and flexibility.

Review the development of a high-strength synthetic gene promoter that boosts titers while ensuring product quality and expression stability for efficient biomanufacturing.

Wearable technologies for extended high-volume biologic dosing must prioritize manufacturability, user needs, and strict quality and regulatory compliance.

Site head Bill Hermans showcases our facility's specialized capabilities in Hopkinton, Massachusetts, and shares how our team serves as a true scientific partner to clients.

With extensive industry experience in both large and small molecule parenteral drug testing, Argonaut can effectively manage your API, Drug Substance, and Drug Product stability study programs.

With over 30 years of proven experience, we provide comprehensive clinical pharmacology services, from data management and analysis to the generation of clinical study reports.

From the production floor to the shipping door, your unique clinical or commercial requirements will be fulfilled at each step of the process.