Management of the impurity profile of an active pharmaceutical ingredient (API) is essential to manufacturing drug substance successfully in a manner that meets sponsor expectations for timeline and quality. The need to identify impurities in drug substance comes from the expectations set out in ICH Q3A (R2), with identification thresholds set based upon the dose of the final API.
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Investors expect pharmaceutical companies to meet commercialization timelines, and failure to do so can have significant financial consequences. Contract development and manufacturing organizations (CDMOs) that have a track record of adhering to project timelines and delivering product on time and in full, regardless of the project’s complexity, have a competitive advantage.
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.
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.
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.
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.
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.
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.