What is CMC ?
Chemistry, Manufacturing and Control (CMC) covers all aspects of the manufacturing of a drug substance and drug product and is often underappreciated in the development cycle. This can lead to a dramatic impact on a program’s timeline, its funding or clinical trial design. More importantly, a poor CMC package can significantly impact the fundraising or partnership often sought to engage into Phase III and commercialization. This is why it is important to design a CMC strategy as soon as the lead candidate is selected. Synmap offers a selection of services designed to help you along your journey towards clinics:
CMC Roadmap / Gap assessment
The key to entering clinics relies on a solid plan to support and mesh all activities together. Upon lead selection, the lack of knowledge and number of uncertainties can make this exercise difficult. This should however never be neglected as the consequences of an early oversight can cause substantial delays, and additional costs. Synmap can evaluate the current state of your project, map all required activities, and help you design suitable scenarios to achieve your goals.
CDMO selection
CROs/CDMOs are a key component to any Biotech’s success and selecting the wrong partner can have disastrous consequences on the program’s budget or timelines. Synmap can assist your team to evaluate and select the right partner for the intended scope of work. Synmap can write your RfP and pre-select a number of partners to receive proposal from. The proposals are compared and evaluated in a comprehensive report, and the result discussed with you and your team. Should you already have received a number of proposals, Synmap can evaluate them in a similar way, and advise on the way forward.
CMC support
During the execution of a development program, the worst that could happen is to be surprised, yet, due to the very nature of development, unexpected events are bound to occur. At Synmap, a systematic, stepwise approach to early phase CMC is applied: Analyze, Plan, Follow. The essence of this workflow is to always be a step ahead by generating data at the most appropriate time, as well as having multiple contingency scenarios ready to be activated if and when required.
Process development
Synmap can support your team in designing chemical processes suitable for early scale up. Having been involved in over 25 early phase different programs, Synmap can guide your CMC team in establishing a DS manufacture process sufficiently developed and robust to allow for early scale up, without overdoing it. Operations to be solved can be focused on in priority, while secondary objectives can be delayed for later phases, should it be preferred for timeline or budgetary reasons.
Project management, technical support & Mentoring
Synmap can provide additional technical support to your team depending on your needs. This can be in the form of coaching and mentoring junior elements, complementing the skillset of an established team, or filling a temporary need of additional operational resources.
Are you looking for a more tailored service? Please do not hesitate to reach out!