GMP Manufacture

Go behind the scenes of GMP manufacturing

Take a virtual tour of our UK GMP manufacturing facilities and discover how we transform promising compounds into GMP-quality materials. See the scale-up, manufacturing, and quality systems that help accelerate your path to the clinic.

What our clients say:

“I am really pleased with the way the Concept team conducted the whole GMP campaign. They have solved key scientific problems that could have impacted our strict timelines, delivery, and quality… they have kept us informed at every stage”

CMC consultant (Andy Baxter for Sareum)

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Our team of dedicated scientists have extensive experience of process scale up enabling the following: 

• Cost-effective small-molecule API CDMO services, that brings certainty to your investment decisions every step of the way. This drives your transition to first in human studies with the right quality standards, ensuring it is on time and within budget
• Ability to rapidly transfer and optimize each stage of your journey from milligram to kilogram of API means that we can stop and restart projects instantly in discrete work packages to match your decision-making process de-risking your investment decisions and reducing development time
• We focus on anticipating, avoiding and over-coming hurdles, by leveraging our scientific and regulatory experience, de-risking your investment

Making the difference in drug substance and registered starting materials (RSM) manufacturing

Each project has its own unique challenges, that’s why we offer a tailored service for RSM and GMP development and manufacture providing:

• Quality: State-of-the-art manufacturing facilities, which are MHRA-accredited support the delivery of your API. Processes for clinical and commercial manufacture have been successfully audited by our global customer base
• Experience: We’ve brought 21 candidates to the clinic for our clients in the last 10 years
• Expertise: We recruit and develop staff from a thriving chemistry ecosystem
• Capabilities: Our ability to work with a wide range of chemistries, including high potency APIs, steroids, sugar chemistry and nucleosides/tides is second to none

Our GMP manufacturing services include:

• Quality Manufacturing: API synthesis for PK studies, GLP Tox, and clinical trials, whilst continuously process de-risking
• Analytical and Material Science: Phase-appropriate development & validation, whilst supporting IMPD / IND filing
• Comprehensive Pre-clinical Evaluation: Safety, efficacy, and pharmacokinetics assessment
• Regulatory Engagement: Open communication with relevant agencies and early issue identification and resolution