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Tech Transfer and Scale-Up for Custom APIs Driven by a Collaborative Culture

Technical expertise and access to state-of-the-art equipment and facilities are necessary but insufficient for successful completion of small molecule API technology transfer projects. Contract development and manufacturing organizations (CDMOs) must have a collaborative culture that encourages open and transparent communication among internal team members, client representatives and other external partners.

Applying Chemistry and Engineering Expertise to Continuous Processing

Flow chemistry for the continuous production of small molecule active pharmaceutical ingredients (APIs) can provide significant safety, environmental, cost and quality benefits. Effective development and implementation of continuous manufacturing solutions requires a combination of chemistry and engineering expertise and the knowledge and experience to determine which processes are suitable for conversion from batch to continuous operations.  

The Link Between a Robust Company Culture and Quality

Integrity and transparent communication are crucial values that enable a contract development and manufacturing organization (CDMO) to provide the best possible outcomes for its pharma partners. These values are fundamental to the interactions between a CDMO and its customers and ensure efficient, effective and phase-appropriate project management throughout the life cycle.

Integrated Outsourcing from RSMs to APIs

As active pharmaceutical ingredient (API) complexity has increased, so too 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. 

Overcoming Analytical Compliance Challenges

Given the need for accurate analyses to ensure the quality, safety and efficacy of drug products that reach the marketplace, analytical method development and validation compliance requirements are both extensive and stringent. They also continually evolve as new types of therapies and advances in analytical technologies are introduced. CDMOs that implement strategies for facilitating analytical method development and validation in anticipating evolving compliance requirements help their customers reach the market sooner while leveraging a more secure supply chain. 

Process Understanding Central to Successful Drug Synthesis

As small molecule APIs become increasingly complex, the development of robust, high-yielding, and cost-effective synthetic routes becomes more challenging. Strategies that emphasize a high level of process understanding facilitate more effective route design and analytical method development.

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