11.17.23 -- "Organizational Outsourcing" For Small Molecules

Risk registers can be a valuable risk management tool, and having a risk register is increasingly becoming a regulatory expectation. It can be structured as a database or spreadsheet and ensures decision makers have key information about risks. Discussion also includes pitfalls to avoid.

This article presents a case study that explores the material and performance properties of spray-dried and jet-milled mannitol for respiratory delivery of crystalline mannitol.

Microencapsulation — wherein particles are co-formulated with polymers or other excipients to improve palatability, modify release rate, or enhance bioavailability — possesses advantages for many pharmaceutical applications.

Review five steps for planning and executing scientifically rigorous, compliant IND-enabling nonclinical studies to help move development programs forward.

Pharmaceutical companies and CDMOs are facing pressure to speed their timelines and reduce costs. Consider the challenges facing developers and how integrated approaches can help advance molecules to IND.

Quadrant 2 helps in early formulation development by employing in silico predictions of formulations via computational modeling analysis of your compound’s specific molecular structure and chemical characteristics.

Pfizer CentreOne has been delivering API and customer confidence for over 50 years. From farm to factory, raw ingredient to API, we can secure a safer supply chain, highest quality API, regulatory support, and transparent timelines.

Finding a strategic CDMO partner that will offer tailored solutions for your late-phase clinical and commercial needs, mitigate risks, and bolster your supply chain is crucial for meeting project milestones on time.