Development of a scalable manufacturing process
How GRA assisted in the development of a scalable purification process for a novel live attenuated viral vaccine for First-in-Man trials.
Critical Consistency
Accelerate development to approval and lifecycle management of your biopharmaceutical products through understanding and control.
Many companies face challenges in developing and documenting the detailed knowledge needed to consistently produce and control biopharmaceutical products according to quality standards.
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.
Our methods and approaches also support advancement and acceleration of AI based product development approaches.
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.
Bioprocess Development & GMP Manufacturing
Good Manufacturing Practice
Good Manufacturing Practice (GMP) ensures that manufacturing processes meet defined quality standards. This includes documentation, validated procedures, trained personnel and controlled environments. The GMP framework helps maintain compliance and data integrity, as well as safety. It also helps ensure that processes perform as intended over time.
Pure and Potent Product
Product purity and potency are assessed at multiple stages of development using analytical and/or Quality Control methods. The focus is to ensure that the product's active substance consistently meets its required specifications for identity, strength and purity. This guarantees that the product always delivers the intended efficacy and is entirely safe for patients.
Process Characterisation
Process Characterisation involves identifying and understanding the impacts of critical process parameters (CPPs), or inputs, on the critical quality attributes (CQAs) of the product, or outputs, Data from scale-down models (SDMs) and experimentation inform control strategies. This builds a robust knowledge base supporting decision-making as well as process performance qualification (PPQ), also called process validation, across the product development lifecycle.
Process Scale Up
During development, a process needs to be taken from small scale to full commercial scale whilst maintaining performance. Parameters identified as important during development are modelled in scale down models (SDMs), validated and used in controlling the process at full scale. The aim, on scaling up, is to retain process consistency, reliability and compliance as production scale increases, ultimately in preparation for PPQ readiness.
Quality by Design and Robust Processes
Applying Quality by Design (QbD) principles to processes allows definition and control of critical process parameters (CPPs) and ranges. Design (Proven Acceptable Ranges) and control (Normal Operating Ranges) spaces are established that maintain process consistency. This allows production teams to work within predefined limits which ensures that the critical quality attributes of the product remain within specification as well as providing regulatory flexibility for any future process modifications.
Clinical and Commercial Supply
Supplying material for late stage clinical trials & commercial distribution requires validated and robust processes with clear control and traceability from Manufacturing to Clinical administration. The goals is to ensure efficient batch-to-batch consistency that is in compliance with global standards, enabling reliable production and timely supply of product, whether for late stage clinical trials or for commercial supply.
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For more detail on how we help with all activities, click here.
frequently asked questions
Frequently Asked Questions
A CMC (Chemistry, Manufacturing, and Controls) consultant supports pharmaceutical and biotech companies in developing and executing the technical and regulatory strategy for how a medicine is manufactured, tested, and controlled throughout its lifecycle.
Depending on the product’s stage of development, the consultant may support:
- Process & Scale-Up: Process development, manufacturing scale-up, and control strategy.
- Analytical Characterisation: Analytical method development, specifications, bioassay development, and stability programmes.
- CDMO Oversight: Technology transfer, CDMO selection, and ongoing operational oversight.
- Regulatory Authoring: Authoring or reviewing the CMC sections of regulatory applications including INDs, CTAs, IMPDs, BLAs, and MAAs.
The CMC consultant helps connect scientific development, manufacturing, quality, clinical supply, and regulatory teams. By identifying technical, regulatory, and operational risks early, they ensure that the CMC programme is appropriate for the current clinical development phase and capable of supporting later clinical phases and, ultimately, commercialisation.