Your CDMO Partner for CMC Regulatory Services

Validated and fully integrated cGMP cell bank production, storage and characterization services support your product’s success from cell line development through to commercial manufacturing.  We provide: 

• non-GMP Research Cell Banks (RCB) 
• cGMP Master Cell Banks (MCB)
• cGMP Working Cell Banks (WCB)
• Cell Bank testing and characterization
• End of Production (EOP) and Limit of in vitro cell age (LIVCA) testing

Stable drug substance and drug product formulations are designed using computational analysis, regulatory-approved excipients, high-throughput technologies, and applying a broad range of stability-indicating biochemical and biophysical assays.  Viewing your molecule as having a unique “personality” ensures long-term manufacturability and produces the safest product for patients. 

We recognize that understanding the unique and complex multidimensional structure of your molecule is critical to understanding its behavior and to build quality into the product during development.  Your partnership with us provides access to gold standard techniques, along with the use of emerging technologies to futureproof your analytical portfolio all the way to commercialization.  

Understanding that you may have many reasons for making alterations to your manufacturing process, or transition from small scale to large scale manufacturing for commercialization, we will work with you to develop robust comparability strategies to safeguard product quality to help mitigate delays to patient access.

Whether you have developed your analytical methods within FDB or transferred in, as your program matures, we will perform method risk assessments and robustness studies to ensure the long-term performance of the method. Formal ICH method validation studies of any method to be used during process validation and conformance lot testing is completed prior to PPQ manufacturing. Validation of analytical methods is governed by internal master plans and adherence to regulatory guidelines, so that you can be assured of testing of process intermediates, drug substance and drug product batch release.

For partners with already validated methods, established gap analysis and transfer mechanisms support the seamless transfer of methods directly into the FDB analytical development and/or quality network.

Across our entire network we execute both accelerated and long-term stability studies on drug substance and drug product for mammalian, microbial and advanced therapies products. We offer study design and management coupled with comprehensive reporting to support your regulatory submission process.

We understand the criticality of timely and successful process characterization to ensure consistent product quality and safety and to support commercialization of biopharmaceuticals. Our global network brings together leading-edge technologies, risk-based study design and customizable workflows to deliver agile solutions during the journey to commercialization.

We partner with you to deliver a custom program that aligns with your filing strategy. Process characterization services can be included as part of your product and process development lifecycle or as a standalone service.

Our philosophy of process validation focuses on a deep understanding of protein science, process risk and the underpinning regulatory framework. Combined with our expertise and track record of approvals, our philosophy allows us to work flexibly to develop and deliver process validation packages and services according to the wide variety of different requirements and needs.

Partnering with FDB on your journey to commercial launch, you will be supported every step of the way by a dedicated regulatory affairs point of contact.  With a proven track record of successful filings with multiple regulatory authorities, you can rely on our guidance and experience to navigate you through current and emerging regulations for biologics and advanced therapies. 

Our regulatory experts understand the evolving regulatory landscape and its impact on key processes and timelines.

The regulatory submission process can be difficult to navigate, and the need to understand and manage the requirements of different regulatory agencies and multiple pathway options means there is no one-size-fits-all mechanism for regulatory support. We have the expertise to guide you whether your submission is a standard filing or needs support with orphan or fast-track applications.