CMC & Manufacturing

Leveraging our extensive experience and expertise in CMC and manufacturing, gained from both industry roles and supporting biopharma companies, we apply this knowledge across multiple modalities and manufacturing platforms to enhance and accelerate your product's success.

Chemistry, Manufacturing, and Controls (CMC) encompasses all activities and documentation required to ensure that a pharmaceutical product is consistently produced and controlled according to quality standards. CMC is crucial for the development, approval, and lifecycle management of biopharmaceutical products. GRA’s expertise spans multiple areas, including Process development & manufacturing, Assays & QC, Formulation development & stability, all complemented by Programme & CDMO management. GRA's CMC offering also includes Quality professionals (including Qualified Persons, QPs) and Regulatory-focused consultants with specific CMC experience (QA, Auditing & Regulatory).

This multi-disciplinary team provides comprehensive support to ensure that biopharmaceutical products meet quality standards, leveraging Quality by Design (QbD) principles and extensive knowledge of relevant ICH guidelines.

Manufacturing a biopharmaceutical product involves several key steps to ensure the final product is safe, effective, and of high quality to which GRA can help organisations from preclinical development to Commercial manufacturing, with experts who can advise on:

• Preclinical Development: post-discovery development of the biopharmaceutical molecules, including proof of concept development.
• Cell line development: involves generation of stable cell lines that produce the desired biopharmaceutical molecule. Multiple steps are involved to ensure the product meets the quality requirements for the ultimate launch of the product.
• Raw Material Sourcing: identifying high-quality raw materials and components that are anticipated to be available throughout process development and into launch is necessary for production.

Process Development:

• Upstream Process: cultivating the cell lines from cell line development to produce the target biopharmaceutical molecule, or in the case of some modalities the cell line itself (e.g. live attenuated vaccines). The process is transferred to cGMP compliant facilities from the process development team in time to support Phase I clinical material generation.
• Downstream Process: purifying the biopharmaceutical molecule to ensure it meets the quality standards outlined in the QTPP and specification. The control strategy will be implemented in both downstream and upstream processes. Commonly the purified product is termed Drug Substance.
• Formulation and Fill-Finish: preparing the purified biopharmaceutical molecule into a final product form, such as a vial or syringe, also termed Drug Product Manufacturing.

• Packaging and Labelling: properly packaging and labelling the product for distribution.
• Quality Control (QC): testing the product to ensure it meets predefined quality standards at various stages of manufacturing and in accordance with a specification at pivotal holding points in the process.
• Regulatory Compliance: ensuring the manufacturing process and product comply with regulatory requirements and obtaining necessary approvals.
• Shipping Validation: We can advise on product shipping, including shipping validation.
• Extractables and Leachables: We can both guide and manage E&L activities for your product, including reports and contractor identification and management.
• Distribution: setting up the delivery of commercial product to healthcare providers or patients.
• Cost effectiveness: developing a cost-effective process involves optimizing resources, reducing waste, and improving yield to ensure the final product is economically viable.

Each step is critical to ensure the biopharmaceutical product is safe and effective for patient use. GRA has experts in manufacturing across multiple modalities and manufacturing platforms that allows us to enhance and accelerate an organisation’s product success.