Making sense of Chemistry, Manufacturing and Controls (CMC)
22nd Nov 2021
Ensuring continued quality and compliance at every stage.
Maintaining high standards of quality, safety and compliance throughout the entirety of any API development and manufacturing project is imperative in the highly-regulated and quality-centered pharmaceutical industry. To ensure the highest quality product and processes through to commercialisation, it is critical to develop a clear and effective Chemistry, Manufacturing and Controls (CMC) strategy early on and adhere to these standards as the project scales. The right end-to-end outsourced partner will possess deep CMC expertise to offer valued guidance, assist with regulatory submissions, and continually raise the bar through new initiatives that put quality and compliance first.
50% of pharmaceutical organisations cite quality issues as the top deficiency that would prompt them to switch outsourced partners.
What is CMC, and why does it matter?
Chemistry, Manufacturing and Controls (CMC) focuses on affirming that a commercialised drug product adheres to the same standards for quality, safety and efficacy that were demonstrated in clinical trials. In order to maintain consistent quality at every stage, it is important to design scalable and repeatable processes, source high-quality raw materials, and leverage robust analytical methods for quality control. These controls will ensure the integrity of your product and processes not only during development and clinical trials, but more importantly, as your product reaches the market at large.
How should your outsourced partner deliver CMC support a teach stage?
While CMC relates to the quality of a finished product, it is critical to begin developing a CMC strategy at a project’s onset and ensure key considerations are addressed at each stage. Your outsourced partner should prioritise CMC activities throughout the molecule lifecycle in anticipation of commercial approval. Let’s take a closer look.
At the onset of a project, it is important to develop a thorough initial CMC strategy that balances speed, cost and regulatory considerations. Your partner should take care to design scalable processes, recommend quality raw materials and intermediates, provide robust drug substance detail, and deliver comprehensive analytical data on key properties. Find out more
Before reaching phase III clinical trials, your partner should help to identify and develop a suitable regulatory starting material (RSM), which will set a benchmark for quality and GMP-compliant manufacturing that endures through the remainder of the project. In addition, your partner should carry out robust impurity assessments and implement effective controls to maintain continued product integrity and purity. Find out more
At the conclusion of phase III clinical trials, a New Drug Application (NDA) is required prior to commercialisation. Your partner should assist in compiling the comprehensive data necessary for a successful NDA. They should also aid inwriting or reviewing the CMC sections of the NDA to ensure accuracy and depth, harnessing their own regulatory knowledge to maximise your chances of approval. Find out more
Once a product reaches the market, organisations often seek ways to improve efficiency and cost-effectiveness at scale. Your partner should not only help to identify opportunities for process improvement, but also perform validation of test methods and preparation of supporting data and documentation amid any process changes. This justification is critical to affirm the continued quality and compliance of any commercialised product. Find out more
Pharmaceutical organisations cite better quality management as the top advantage of an end-to-end CDMO.
Working with a single outsourced partner on CMC activities can save 4-6 months in a novel drug development programme.
Setting the standard for quality from discovery through to commercialisation.
At Sterling, our full-lifecycle perspective, end-to-end capabilities and exceptional track record enable us to proactively consider quality at every stage. With deep expertise in global regulatory requirements and a dedicated CMC services team, we ensure that the products and processes we develop on behalf of our clients maintain consistent high quality as a project moves from early stage discovery through commercial release and beyond. As a PDMO®, or partnership development and manufacturing organisation, we closely collaborate with our customers to consistently exceed their expectations for quality, efficiency and regulatory success.
Service
We pride ourselves on being easy to do business with, removing layers of complexity, maximising flexibility and adaptability to your requirements, and doing what we say we will do, again and again.
Passion
We promise to treat your molecule as our own, drive progress by continually exploring new and emerging capabilities, and do the right thing for our people and planet.
Science
We combine our expertise in complex and hazardous chemistry, our world-class facilities and our full-lifecycle capabilities to place scientific excellence at the core of every solution we deliver.
