Whether you manufacture in-house or will be assembling a network of contract service providers, BioTechLogic offers support to ensure that your therapeutic is manufactured in a quality, efficient, and cost-effective manner.
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.
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’ll help you to gain a complete understanding of your processes and support gap identification. We also offer GMP training services and can be on the ground at your CMO facility during manufacturing runs.
Whether preparing for and supporting an external GMP audit by a global regulator [pre-approval inspection (PAI), pre-licensing inspection (PLI)] or planning and executing an internal audit, our team offers comprehensive capabilities.
To ensure successful inspections, we conduct a risk evaluation well in advance of your inspection window. This assessment identifies high-risk areas in your supply chain, informing an inspection readiness plan and effective resource allocation.
Grounded in root cause analysis, our team supports facility performance and process troubleshooting initiatives. Additionally, the BioTechLogic team supports ongoing process optimization to improve yield and efficiency.
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 and other recombinant proteins in various forms of delivery (liquid, lyophilized products, suspensions).
The following are examples of services to help support combination products throughout product development and into commercialization:
