Formulation development serves as a vital bridge between a drug substance and a drug product that will remain stable and ...

In the last 10 years, there has been significant development in computer simulation of pharmaceutical materials, processes and product performance. Gradually, more mechanistically based models are ...

Biosimilar formulation development requires navigating around scientific, regulatory, and legal challenges, according to Sung ...

Drug development often progresses from one phase to the next without considering long-term feasibility, such as scalability, cost-effectiveness, and market access. Sustainable success is assured by ...

In this Pharma Matters Q&A, Anshul Gupte of PCI Pharma Services discusses investments and opportunities in sterile ...

This white paper offers concise, practical guidance for biopharma teams outsourcing Process Characterization (PC) to strengthen CMC packages and accelerate commercialization. Get the essential updates ...

Process characterization and viral clearance validation are pivotal studies in biopharmaceutical manufacturing, particularly for monoclonal antibodies (mAbs) produced in mammalian systems, which carry ...

Offers Lifecore Key Access Point into Manufacture and Fill/Finish of Next-Generation Biotherapeutic Formulations with Potential to Deliver Significant Benefits to Patients Worldwide CHASKA, Minn., Oct ...