Recognize these API drug development challenges?
During API development, the race is on to predict which drug candidates will meet performance and processing requirements and which should be dropped from the development pipeline.
Many organizations suffer from a lack of resources, in-house expertise, and time – making it difficult to answer questions around developability and dosage form.
Those working in API development face several challenges that threaten the stability of their program, including:
- Development teams spread across multiple drug development programs, limiting the ability to focus resources on determining which APIs should ‘fail fast’ and which should be accelerated in development to enable market introduction of critical new therapies
- Difficulty in selecting and developing the right analytical method, preventing you from generating the data you need to enable critical decisions, slowing progress and risking late-stage failures in product development
- Keeping up to date with the ever-changing guidelines put in place by regulators such as the FDA and EMA, and having confidence that the selected analytical approach is scientifically valid and will be accepted as part of a regulatory submission
- For smaller companies, selecting the right level of capital expenditure to progress through the development pipeline without risking budget overruns or limiting access to the required equipment and expertise
Amplify Analytics is a partnership between Malvern Panalytical and Concept Life Sciences that provides a fully flexible, integrated service to help overcome API development challenges:
Our team works flexibly with you to overcome your specific API development challenges – enabling faster pipeline delivery and providing the data package and interpretation needed to get your products to market faster.
Concept Life Sciences’ medicinal chemistry expertise and comprehensive understanding of the global regulatory environment is coupled with Malvern Panalytical’s advanced analytical instrumentation and knowledge:
- Gain access to in-depth analytical API formulation development expertise supported by cutting-edge physiochemical analysis tools (from compositional to morphological and structural analysis) to truly determine which methods will enable rapid decision making and reduce your time to market
- Work with us to select the right analytical method for your program, based on the elements that best support the critical quality attributes of the project
- Benefit from our flexible project management approach, where we form an agile partnership with your team, so you can decide which elements to outsource and which to keep in-house.
- Partner with your dedicated account manager, who will act as your ambassador and ensure that our resources, expertise and analytical solutions are allocated where you need them.
- Access our deep, up-to-date understanding of the global regulatory landscape regarding the selection of appropriate development and analytical strategies, so our team can help ensure your program is kept in line with constantly evolving regulatory guidelines
Our unique approach enables us to work as an adaptable partner, providing integrated drug discovery and API development services across the whole development pipeline.
We can help determine which analytical methods will quickly eliminate non-viable drug candidate formulations for more rapid pipeline delivery – helping you get to market sooner.
Case study: The power of collaboration to overcome API manufacturing challenges
Appropriate analytics deliver results fast: The Amplify Analytics team supported a virtual pharmaceutical development company through the challenge of taking an API formulation from discovery through to GMP manufacture in under 36 months.
Concept Life Sciences’ medicinal chemistry expertise in the hit-to-lead phase ensured the suite of potential candidates was rapidly synthesized on a milligram scale and initially screened against the target using relevant assays. This led to the proposal of three candidate molecules for gram-scale synthesis and further testing. At this point, Malvern Panalytical’s physicochemical analysis tools and expertise quickly eliminated two candidates based on developability criteria, leaving one candidate to progress to Process Research & Development and scale-up. The synthetic route was substantially altered to more readily achieve high yields, and a process was developed to eliminate the need for chromatography to purify the compound – this increased the yield whilst lowering the cost of materials and reducing waste.
This process was transferred to Concept Life Science’s GMP plant, and the first GMP batch was released just 32 months after the client first engaged with our team.