GMP Manufacture

Our GMP manufacturing services offer a customized, phase-appropriate approach to API development, from candidate nomination through to IND submission.

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 derisking 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

‍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)

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 both FDA-audited and 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: Based in Sandwich UK we recruit, retain 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

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