The optimal cGMP manufacturing strategy is critical to the success of any CGT program, but is often cited by developers as one of their greatest challenges. Deciding how and when to contract and/or build the appropriate manufacturing capacity of an adequately compliant state can be a complicated enterprise. Our experienced team can assist you in all aspects of this process in addition to providing expert advisory, leadership, and technical SME support in reaching operational excellence.
Introducing ICMC™: Initiative for Certification of Manufacturing Capabilities, delivered by DHC. ICMC is designed to close a critical gap in the CGT CDMO market by providing a level of transparency and trust that was otherwise lacking. ICMC also allows CDMOs to build credibility and differentiation in the marketplace while offering therapeutic developers a way to more robustly evaluate CDMO partners.
We build highly flexible quantitative capacity and cost models to help you optimize capacity planning, identify opportunities for cost reduction, and identify whether in-house or outsourced manufacturing best suits the needs of your development program.
Using our proprietary, quantitative RFP process and our deep knowledge of the CGT CDMO landscape, we work with you to establish a bespoke URS, author your RFP, solicit responses from qualified contract manufacturing organizations (CMOs/CDMOs), audit lead candidates, and evaluate responses to select the optimal partner for the specific needs of your process and organization.
We hand-carry your process to its new home to ensure success of your technology transfer, whether in-house or to a CMO. We prepare your technology transfer package, oversee planning and execution of the process transfer, and provide person-in-plant support for the transfer.
For clients currently without internal leadership focused on this core capability, senior DHC experts can provide interim expertise and leadership with the goal of enabling the clients to identify, hire, and onboard internal candidates in a timely manner.
We use formal root cause analysis tools like Fishbone Diagrams, Failure Modes and Effect Analysis, and statistical analysis to identify root causes underpinning lot failures. Once root cause(s) are identified, we assist you in identifying, implementing, and documenting appropriate CAPAs to prevent them from re-occurring.
Our facility mapping team and proprietary software can model facility size requirements, equipment and instrumentation needs, and FTE by department over time under the full range of reasonable input assumptions. This enables you to consider robust planning scenarios even in environments of great uncertainty.
Common requests include facility user requirement specification, quality/GMP, regulatory reviews, and equipment specification and selection.
We offer a full range of project management offerings as well as two elements that are specifically likely to cross over to FD&E: project risk evaluation/risk management and owner’s representation. Risk evaluation and management are particularly relevant when completed by a team with deep technical expertise in CGT manufacturing. Owner’s representation also falls under this umbrella.
Two critical elements to address at early stages of facility design and buildout are that of equipment specification and selection as well as contractor and supplier audit/selection. DHC clients benefit from our overview of the entirety of the market when deciding from among a range of contractor and supplier options. Just as with CDMO selection in our Manufacturing Support offering, we provide our clients with our proprietary and quantitative RFP process, as well as our unparalleled knowledge of the cell and gene therapy landscape. The degree of support that we offer here is, as always, à la carte and based on each client’s specific needs.
Test suitability, compliance, and readiness of systems for your intended use with a mock audit, be it an FDA inspection dress rehearsal, clinical phase GMP audit, or strategic session. Common mock audit requests are in preparation for audits by a future customer, a technical collaborator, a regulatory agency, or a potential investor.
Remediations are necessary in a variety of situations during the development timeline; common remediation responses may include a 483 remediation, clinical hold, a product complaint or adverse event, or Complete Response Letter (CRL).
To provide support for a remediation or to ensure future compliance, we offer customized teach-ins designed to fit the scope of your needs.
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