Selecting the Ideal CDMO for Clinical Success

Why choose Concept Life Sciences as your CDMO of choice?

Discovering and developing promising therapeutic candidates is just the beginning of a complex journey towards clinical success. When the time comes to transition your candidate from lab to the clinic, selecting the right Contract Development and Manufacturing Organization (CDMO) is crucial.

Expertise and experience

Partnering with a CDMO that possesses extensive experience in developing, manufacturing and releasing a wide range of APIs for different therapeutic modalities (small molecules, HPAPI, controlled substances, peptides) is critical. Our track record highlights our approach towards proactive risk management; we look to identify & mitigate any potential issues early in the development process. This can be as early as when making the pre-clinical tox batch. We understand the pace at which material is required at this early phase, so our focus is to supply material as quickly as possible. All our process development activities are phase appropriate, but we also want our synthetic routes to be fit for future commercial supply.

State-of-the-art facilities and technologies

Multiple manufacturing streams offers us and our clients the flexibility required to strategically utilize our teams efficiently and to expedite delivery along the critical path. Our facilities are state-of-the-art, and we’re equipped to handle all types of chemistry including cryogenic reactions, handling reactive & high potent materials and carrying out pressure reactions including hydrogenation and carbonylation. Our scientists utilize statistical experimental design (DoE) in combination with parallel screening to identify key variables and optimize reaction conditions. Advanced technologies like continuous flow reactors facilitate large scale delivery of APIs in a safe and sustainable manner.

Customized solutions and flexibility

Each project is unique and rather a one-size-fits-all approach, we always tailor our service to the challenge at hand. We offer flexible solutions that adapt as your needs change. We have the ability to handle various batch sizes, from small scale clinical trial supplies to larger commercial quantities. In addition, the drug development landscape is constantly evolving and regulatory changes such as the issue of nitrosamine contamination highlight the importance of being able to understand and respond to updated guidance. We’re forward-looking and have a track record of being able to incorporate innovative solutions into our workflows to ensure our client projects continue to move forward.

Quality and regulatory excellence

Having delivered many GMP manufacturing campaigns, our reputation for compliance with all necessary regulations is beyond doubt. Our facilities and way of working have been accredited by the MHRA to supply clinical and commercial APIs. As you would expect, we prioritize product quality and safety, implementing robust quality assurance and control systems. We select and approve vendors from whom we purchase our raw materials. At Concept Life Sciences, data integrity is of the highest standard throughout the development and manufacturing phases. We are also able to offer support in navigating the complex regulatory landscapes, assisting with documentation and submissions to accelerate your drug candidate’s path to the clinic.

Speed and cost effectiveness

We know that time and budget constraints are key considerations in drug development. Our track record shows that we always deliver on time in full and within budget. Our seasoned scientists uncover any potential issues (synthetic and impurity control, analytical, solid-state chemistry) and ensure these are fixed prior to manufacture. The right blend of technical expertise spread across three teams enables us to deliver with speed.

Customer centricity

We place our clients' needs, goals and success at the heart of our operations. We take time to understand your unique project requirements, preferences, and importantly, how you want to collaborate Customer centricity is pivotal – we offer a ‘lab down the corridor’ approach and function as an extension of your team, working with you to deliver your project and help you achieve your next milestone.