Our Chemistry, Manufacturing and Controls (CMC) services team works alongside customers to provide guidance and advice on the technical and regulatory considerations throughout the lifecycle of your active pharmaceutical ingredients (APIs), from discovery, through to launch and commercialisation.
What is Chemistry, Manufacturing and Controls (CMC)?
CMC involves defining the manufacturing processes, molecule characteristics and API and intermediate testing at each stage of the drug product lifecycle to ensure the product is safe, effective and consistent. It sits at the heart of all aspects related to the development, manufacturing and commercialisation of pharmaceutical products to support clinical trials and licensing applications.
What CMC services do Sterling offer?
We have a dedicated team of CMC experts that can provide advice and guidance, alongside the work already being carried out by our development and manufacturing teams, creating a single source for the drug substance data required by regulatory authorities.
The team provide regulatory support; prepare and review submissions for the relevant regulatory authorities, based on their extensive knowledge and experience.
We can work with you at whatever stage of the drug lifecycle; as an extension of your team from helping define your CMC strategy to writing the entire CMC section of your submission.
At what stages does a pharmaceutical drug require CMC submissions?
Pre-clinical CMC support
At this discovery stage of a potential new drug, known as an IND (Investigational New Drug) in the US and IMP (Investigational Medicinal Product) in the UK, the key focus is to set out an initial strategy for the CMC programme.
Often the focus is on getting a product to clinical trial as quickly as possible, however a minimalistic approach may risk approval, and creating limited data to support the CMC approach at this stage, may cost time in the long term.
Our team can provide guidance on the balance between speed, cost and regulatory success.
Sterling offers a range of CMC services to support the application process in several territories across the globe including US, UK, EU, Japan and Canada. The services we provide include:
- Outlines of the manufacturing process; a detailed description of each stage of the manufacturing process, including flow diagrams, methods of isolation and purification.
- Control of Materials; recommendations for specifications for raw materials and process intermediates.
- Characterisation of Drug Substance; including phys-chem properties such as particle size distribution (PSD), polymorph assessments and in silico modelling.
- Control of Drug Substance; analytical data including identity, purity, potency of the API substance.
- Control of Drug Substance; impurity identification, characterisation and synthesis services.
Clinical phase to commercial launch CMC support
Our CMC experts can advise on the activities required at each phase of the clinical trial program.
Phase I & II CMC services:
Regulatory Starting Material (RSM) selection; defined as a starting material that is incorporated or provides a significant structural fragment of the final structure of a drug substance, the selection process and defining the non-GMP/GMP (Good Manufacturing Practice) interface is required before embarking on a phase 3 clinical trial program.
Potential Genotoxic Impurities Assessments in alignment with M7 requirements including silica structural assessment; includes assessing the potential to form genotoxic impurities and their identity.
Fate and Tolerance of Impurities; a stage by stage investigation of the impurities formed during the manufacturing process. The investigation will also determine the tolerance of the purification processes and identify additional controls required to meet specification of the API substance.
Phase III CMC services (NDA support):
Sterling offers process validation services as part of the API manufacturing capabilities; this generates process data required in the NDA submission. Our CMC experts can review the data to draft the CMC sections of the NDA filing.
Post-launch CMC support
The services provided by Sterling in the post approval phase include recommendations for the improvement of process, validation of improved test methods, onboarding of new raw material vendors and investigations into alternative routes of synthesis for RSMs. Any change to the manufacturing process has an impact on the regulatory filing for the commercial product. Our CMC experts can provide the data required and justifications in order to ensure the changes to the process do not impact the approval of the drug product.
If you would like to discuss Chemistry, Manufacturing and Controls work with our team please click here and we will direct your enquiry to the relevant team.