瑞马迎春贺新岁 We welcome the Year of the Horse!
CMC can make or break product approval, as our experts know well. Time spent on getting CMC development right will nearly always pay dividends by streamlining next steps towards regulatory approval and commercialization.
DHC, BioTechLogic, and Converge all have robust teams of CMC experts available to develop, optimize, and validate thorough, scalable, cost-effective, and compliant manufacturing processes. We offer hands-on phase-appropriate development support for all aspects of CMC and biopharmaceutical development under R&D and GMP conditions.
Our team's depth and breadth of experience helps you navigate and overcome various challenges, including:
Essential to CMC program success, we design phase-appropriate analytical methods, optimization and validation plans tailored to your product and processes. We recommend the utilization of fit-for-purpose assays and advanced statistical approaches to support the identification of your product's critical quality attributes (CQAs).
We support and execute the authoring of comprehensive documentation, process descriptions, data trend analysis, and supporting study reports for your product's process development and optimization journey.
Our consultants have a thorough command of diverse analytical techniques supporting comprehensive characterization, including functional and physicochemical assays, of your drug substance and/or drug product.
Our team's unmatched multi-disciplinary expertise is available to support you throughout the full lifecycle of your product development.
We leverage our extensive experience gained from working on thousands of projects at all stages of development to support you with:
Our team can provide support throughout the full lifecycle of device development, including:
Leveraging design of experiments (DOE), we perform a systematic evaluation of your manufacturing process, establishing a thorough understanding of how critical process parameters (CPPs) influence your final product's critical quality attributes (CQAs). Additionally, our process parameter risk assessments identify the process parameters posing the highest risk to your production process to support risk mitigation planning.
Creating a foundation for your product and process development program, we utilize a QbD framework to thoroughly understand the quality characteristics essential for ensuring consistent, reliable, and reproducible execution and product quality, as well as for safely delivering your drug product's intended therapeutic effect.
Preparation, documentation, and oversight to ensure the seamless transfer of your method to CROs, CDMOs, and other service organization partners.
We work with you on-site or virtually to identify, diagnose, and resolve analytical problems or inconsistencies.
We support data integrity, end-to-end traceability of analytical data from collection, analysis and data management for your quality systems, regulatory filings, CMC submission summaries, and beyond. Additionally, we assist with SOP generation and management to ensure excellence in analytical execution.
Examples include:
Our experience managing pre-qualification, validation, optimization, and CPV for all modalities and production technologies includes managing laboratory scale processes, pilot plants, and large-scale processes. This includes the development and validation of the following: precipitation, centrifugation, microfiltration, depth filtration, cell disruption (microfluidization, homogenization), and periplasmic extraction.
Thorough analysis, often including an extractables and leachables risk assessment, of the impact of raw materials, excipients, consumables, and intermediates on process performance and product quality includes program design, procedure creations, external laboratory identification, results review, and mitigation strategies.
We offer site development and capacity planning support if you plan to scale in-house manufacturing. We also support clean room validation and personnel training. If you are working with a CMO partner operating multi-product facilities, we can thoroughly assess the facility and conduct a cross-contamination risk assessment. We're experienced in assessing and qualifying systems such as WFI/purified water, clean steam, and air handlers. If new products are being brought onsite in anticipation of audits/PAI, we assess for regulatory compliance and capacity.
Since CDMO selection is unique for every client, we assist based on specific project objectives and variables, including process development assistance required, needed capacity, development timelines, and tech transfer costs. If desired, we can also manage contract partner programs. Our proprietary CDMO database and established methodologies ensure a good fit for your program.
We expeditiously address operational challenges and bottlenecks, including:
Grounded in sound scientific principles, decades of hands-on execution experience, and sounds science-based root cause analysis, our team supports operational performance and process troubleshooting initiatives. Additionally, we support ongoing process optimization to improve product quality, yield, and efficiency, and reduce deviation recurrence.
Whether you will be scaling up your process within your own facilities or working with a contract services partner, we'll support your technology transfer plans, including technology transfer protocols, scale-up feasibility assessments, risk management plans, commercialization master plans, and guide associated studies.
If you require real-time, on-the-ground oversight, troubleshooting, and/or remediation, we oversee execution and ensure compliance with regulations and procedures, as well as supporting gap identification. We also offer GMP training services and can be on the ground at your CMO facility during manufacturing runs.
Our overall production expertise includes compounding, sterile filtration, component and equipment preparation, aseptic filling and stoppering, lyophilization, capping, labeling, and packaging operations. We have supported and managed drug product production for various biologic compounds including PEGylated proteins, PEGylated antibody fragments, vaccines, blood products recombinant proteins, and gene therapies in various forms and presentations (liquid, lyophilized products, and suspensions in vials and syringes). We can also assess & improve or implement visual inspection and inspector qualification programs for drug product manufacturers.
We develop detailed project communication plans and matrices, ensuring transparent and accurate communication.
We track and report progress throughout the project, enabling all stakeholders to clearly understand the project status and upcoming activities and milestones. Along this journey, our project managers carefully track and expedite the resolution of action items, highlight critical project issues and risks, and facilitate the development of mitigation action plans.
Every project must have a defined goal, detailed plans, and an established schedule. We define and document team structures, roles, responsibilities, and what will be accomplished upon completing the project.
Even the best-managed projects and programs encounter challenges. Our project managers ensure clear, honest, and transparent communications as issues are explored, effectively prioritized, and resolved.
To provide support for a remediation or to ensure future compliance, we offer customized teach-ins.
For clients currently without internal leadership in this domain, our senior experts can provide interim expertise and hands-on leadership with the goal of enabling the clients to identify, hire, and onboard internal candidates in a timely manner.
We oversee your project to achieve your milestones in a timely fashion, including maintaining up-to-date project timelines, organizing project team meetings, capturing meeting minutes, establishing RACI (responsible, accountable, consulted, informed) matrices, and following up on achievement of action items.
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