Newsletter | July 15, 2019

07.15.19 -- Overcoming Challenges In API Development And Manufacturing

Accelerate Complex Molecule Development By Optimizing Chemical Synthesis And Formulation

Finding a balance between a complex API, its formulation, and its synthesis requires equipment, knowledge, and processes more extensive than those typically required for traditional drug development. It also calls for collaboration across several teams in order to break down the silos that can interrupt the flow of open and clear communication.

Quality By Design: A Holistic Approach To Drug Development
As the biopharmaceutical industry continues to evolve, the quality by design (QbD) holistic and proactive approach to drug development and manufacturing is transforming key processes. While QbD evolves from good practice to agency requirement, how can sponsors ensure that rigorous, scientific risk-based approaches are used to bring better and safer therapies to market faster?
Six API Challenges That Could Be Slowing Your Development And How To Avoid Them
The challenges for new drugs looking to enter the market are numerous and varied. But many are self-inflicted — especially in small molecule development. A dangerous perception persists that, aside from highly potent APIs, small molecule medications have simple process requirements. Having a solid understanding of the most common API challenges can help to avoid development delays, rework, or outright failure.
Flow Chemistry: A Scale-Up Solution For Modern API Development And Manufacturing

Once deemed an “experts-only” approach to chemical synthesis, flow chemistry is a cost-efficient technique growing in popularity that can facilitate scale-up, improve product quality, and even address some of pharma’s biggest challenges, such as drug shortages and recalls.

Meet The API Drug Substance Team At Patheon’s Florence, SC, Site

Watch the video to meet Patheon’s (part of Thermo Fisher Scientific) API drug substance team and get an inside look at their Florence, SC, facility.