BioTechLogic’s team of CMC experts works with clients to develop, optimize, and validate robust, scalable, cost-effective, and compliant manufacturing processes. We also offer hands-on phase-appropriate analytical development support for all aspects of CMC and biopharmaceutical development under R&D and GMP conditions. In addition to outstanding scientific and technical skills, BioTechLogic offers robust project and program management with all our engagements.
Our CMC Service Domain comprises all service offerings previously listed under the Core Capabilities of Product & Process Development, Analytical Development, Facilities, Manufacturing, & Compliance, and Project & Program Management.
We offer site development and capacity planning support if you plan to scale in-house manufacturing. We also support cleanroom validation and personnel training. If you are working with a contract manufacturing 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.
BioTechLogic supports our clients’ selection of CDMOs and other contract service partners. 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 in a hands-on manner on an ongoing basis.
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, BioTechLogic provides Person-in-Plant (PiP)and suite management. We can oversee execution and ensure compliance with regulations and procedures, as well as support gap identification by helping you identify and address opportunities for improvement. We also offer GMP training services and can be on the ground at your CMO facility during manufacturing runs.
Grounded in sounds 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, the BioTechLogic team supports ongoing process optimization to improve product quality, yield, and efficiency, and reduce deviation recurrence.
BioTechLogic has over 20 years of experience in aseptic fill/finish manufacturing experience throughout the United States and Europe. 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.
The following are examples of services to help support combination products throughout product development and into commercialization:
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.
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, as well as regulatory filings.
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.
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 up to 30,000 L scale. This includes the development and validation of the following: precipitation, centrifugation, microfiltration, depth filtration, cell disruption (microfluidization, homogenization), and periplasmic extraction.
Essential to CMC program success, we design, optimize, and validate phase-appropriate analytical methods 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).
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.
Preparation, documentation, and oversight to ensure the seamless transfer of your method to CROs, CDMOs, and other service organization partners
We support end-to-end traceability of analytical data from collection and analysis to data management for your quality system, regulatory filings, CMC submission summaries, and beyond. Additionally, we assist with SOP generation and management to ensure excellence in analytical execution.
We work with you on-site or virtually to identify, diagnose, and resolve analytical problems or inconsistencies.
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.
With the established projects, team, and roles and responsibilities, 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.
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.
