NEWS & BLOG

Articles

Does Your CDMO Have Sustainable API and RSM Strategies?

By Scott Martin, Grace FCMS -  A wide range of factors are reshaping today’s pharmaceutical supply chains. This includes, but is not limited to, a growing pipeline of diverse small molecule products, emerging markets that continue to reshape the industry landscape, and increasing regulatory expectations. Now the world is facing COVID-19, which is driving many pharmaceutical companies to reexamine their supply chain strategies and footprints. Despite these challenges, it is the responsibility of the pharmaceutical innovator to make sure they establish a reliable supply chain that is compliant with global regulatory expectations. A critical part of doing so is having regulatory starting material (RSM) and active pharmaceutical ingredient (API) strategies that ensure continuity of supply throughout the life cycle of a product.

Integrated Operations Produce Top-Tier Raw Materials

As active pharmaceutical ingredient (API) complexity has increased, so has the raw material supply chain. Drug manufacturers must ensure that these materials meet strict regulatory guidelines regarding impurity levels, that their quality is well documented to mitigate risk, and that they can be traced throughout the supply chain. An integrated supply chain, with transparency among sponsors and suppliers, ensures that regulatory starting materials (RSMs) are well characterized and free of impurities that can impact the final drug product.

Meeting Delivery Milestones Through Collaboration and Communications

Investors expect pharmaceutical companies to meet commercialization timelines, and failure may carry significant financial consequences. CDMOs with a track record of adhering to project timelines and delivering products in full, regardless of project complexity, have a competitive advantage. This is best achieved through a cooperative culture, driven by open dialogue with clients.

Overcoming Impurity Analysis and Regulatory Compliance through Smart Supply Chain Management

Accurate analysis ensures the quality, safety, and efficacy of drug products that reach the marketplace. However, method development and validation regulations are extensive and stringent, and they are continually evolving as new therapies and analytical technology advancements are introduced. CDMOs can help their customers reach the market sooner if they anticipate evolving compliance requirements, and then implement corresponding method development and validation strategies. Those strategies should include a robust plan for supply chain security.

Tech Transfer and Scale-Up for Custom API's

The complexity of small molecule APIs is growing rapidly. Many drug substances contain multiple heterocyclic rings and functional groups; they are designed with ever-increasing specificity in mind. While these novel compounds targeting cancer and other diseases enable more and more personalized treatments, they also pose immense challenges from a manufacturing perspective.

The Link Between a Robust Company Culture and Quality

Integrity and transparent communication are crucial values, fundamental to the interactions between a CDMO and its customers. They ensure efficient, effective, and phase-appropriate project management throughout the life cycle.

Understanding Multinational Regulatory Filings: New Chemical Entity

By Jim Springer, Steve Halpin, and Megan Kuikstra, Grace FCMS -  Finding the right long-term CDMO partner for development and commercial launch of a new chemical entity (NCE) presents sponsors with a uniquely challenging scenario. First, “right” must be defined in quantifiable metrics, then the search begins for a CDMO exhibiting those qualities. The challenge is magnified when a multinational launch is planned.

Impurity identification in Small-Molecule APIs

Timely identification of impurities is critical for maintaining clinical and marketing timelines, and it requires a unique combination of process chemistry knowledge and considerable analytical capabilities. At Grace Fine Chemical Manufacturing Services (FCMS), we keep customers on track by combining decades of pharma research and development experience with teams who closely collaborate on all elements of process development, from the kilo lab to commercial production.

A Practical Look At Flow Chemistry

By Scott Martin, Grace FCMS -  There has been much discussion about the potential impact of “flow chemistry” on pharmaceutical manufacturing. While the technology does hold promise for the future, it also presents many challenges and choosing the right application will be critical to overcoming them and ensuring a successful implementation.

Applying Chemistry and Engineering Expertise to Continuous Processing

There is ongoing discussion in the pharmaceutical industry today about the potential benefits of flow chemistry and continuous processing. This approach to chemicals manufacturing is not new; it has been widely applied for decades in the chemical process industries for the consistent, economical production of high- volume products.