GMP manufacture of your API
Amplify Analytics offers current Good Manufacturing Practice (cGMP) API production and QC to exceptionally high standards of quality, speed and efficiency. Our teams enable a smooth, robust transition from development to API production, via our in-house GMP manufacturing facility. Collaborate with an agile partner to ensure analytical continuity throughout the drug development pipeline.
Ensuring GMP-compliance for products and processes
As an API moves from candidate selection towards scale-up for clinical batches, GMP activities must be overseen by a dedicated QC department, to ensure all batches are delivered on time, with exceptional yields and at the highest quality.
The handover between development phases can raise challenges, including:
- Accessing the right expertise and equipment to ensure compliant processes and products when progressing from early development to manufacturing
- Ensuring the right analytical techniques are in place to drive development and maintain process continuity, facilitating fast and robust product development while minimizing the risk of late-stage failures
A smooth transition between development and clinical manufacture will ensure key regulatory and development milestones are met.
Amplify Analytics accelerates the progress of your API to early phase trials, preparing you for commercial success
Our team will form a flexible partnership with you, guiding you through the entire development pathway, right through to GMP production.
Between Malvern Panalytical’s enhanced instrumentation and analytical expertise and Concept Life Sciences’ deep understanding of the regulatory landscape - supported by a dedicated GMP facility –Amplify Analytics can help you overcome your manufacturing challenges.
- Our program management model is fully flexible and agile, so you can choose your level of involvement at any stage
- We work as a collaborative partner to help guide you through the entire GMP scale-up process, from early development through to Phase I manufacturing. You can rest assured that your program will be fully compliant, with all required documentation fulfilled, significantly reducing both your workload and your time to market
- Our approach focuses on achieving continuity across the entire pipeline, via consistent input and support on analytical method/technique selection and validation. In this way, we ensure that the transition to manufacturing is smooth, key milestones are consistently met, and all processes and methods are robust, delivering a successful candidate to clinical trials
- Each project is managed by a single point of contact, supported by primary scientific and senior management research leads. Our team actively manages KPI and budget tracking to ensure agreed scopes are maintained, enabling you to focus on the results
How can we help you overcome your GMP challenges?
To find out how our integrated team of experts can help you accelerate your product development and speed your route to market, contact us today.