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GMP Manufacture

Concept Life Sciences offers a bespoke, phase appropriate approach to API development, from candidate nomination through to IND submission. Whether you need support on your journey from milligram to kilogram, or a discrete work package to help meet your next milestone, Concept Life Sciences’ team of process chemists can help expedite your project. Cost, quality, and time are all balanced to ensure development of a fit-for-purpose chemical route. State-of-the-art manufacturing facilities, which are both FDA-audited and MHRA-accredited support delivery of API.

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A more in-depth view

GMP Manufacturing 

Phase-appropriate process optimisation saves time and money, but still facilitates delivery of a specific milestone.  The banked knowledge can always be used for further optimisation to achieve a future milestone. 

  • Concept Life Sciences have teams of dedicated scientists operating out of several manufacturing facilities with extensive experience of process scale up. ‍
  • A culture of open communication facilitates transfer of knowledge between the process optimisation and scale up teams. Sharing experiences helps to avoid bottlenecks and overcomes problems more efficiently.
  • A commitment to delivering detailed technical transfer documentation prevents knowledge-attrition. Critical quality and processing parameters are especially important for future successful scale up campaigns.

Drug Substance and Registered Starting Materials (RSM)

Each project has its own unique challenges, that’s why Concept Life Sciences offers a tailored service for RSM and GMP development and manufacture.  

  • Concept Life Sciences has a proven track record of GMP delivery.
  • Operational, state-of-the-art, and regulated GMP facilities, housing a range of glass and Hastelloy vessels between 10 L and 100 L in size can supply multi-kilogram batches of API.
  • An experienced quality department ensures the facilities and GMP campaigns are MHRA and FDA compliant. Concept Life Sciences welcomes customer audits of the facilities and robust quality management system. Click here for more information on quality.
  • A dedicated procurement team support cost management and ensure quality and GMP requirements are built-in right from the start.  
  • Program management acts as a client’s advocate, ensuring seamless communication, full transparency, a flexible approach to problem solving and a successful project outcome.
  • QC and GMP release testing, including storage stability studies, can be built-in to any work package.