OUR SERVICES
Short phrase here
Process Development
Critical to every biologics CMC program is the need to develop an effective, robust, and scalable process that allows for the expression and purification of valuable protein products.
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BPAI can assist your organization with partial or full process (upstream, midstream, and downstream) development and optimization, as well as with creating product quality testing and validation protocols.
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Our goal is to work seamlessly with your team, providing leading edge guidance and assistance on the production and purification of products derived from microbial, yeast and mammalian sources.
Analytical Development
​Reproducible analytical methods supporting process development and product testing are critical to the success of any clinical trial development or manufacturing program.
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Creating analytical transfer protocols for inter-site studies
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Creating assay qualification and validation protocols
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Real-time monitoring and interaction with service providers during protocol execution
Technology Transfer and Scale-up
BPAI has a successful track record of transferring and scaling microbial, yeast, insect and mammalian cell processes from bench to established manufacturing scale. Our team provides effective assistance during technology transfer, ultimately ensuring your peace of mind. Critical technology transfer services offered by BPAI include:
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Drafting, review, and approval of technology transfer protocols
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Monitoring lab-scale proof-of-concept runs at the receiving site
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cGMP readiness, robustness, and scalability process assessments
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Person-in-plant and real-time assist during technology transfer phase
Manufacturing
Manufacturing processes are the pinnacle of every development program, where considerable amounts of time, energy, and resources are poured into a single run. We understand the importance of manufacturing, which is why we tailor our support services to your organization’s needs. The following is a list of manufacturing support service offerings:
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Drafting and review of quality-related manufacturing documents (e.g. process flow diagrams, BOM, batch production records, SOPs, material/product specifications)
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Person-in-plant during critical unit operations and oversight during manufacturing
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Post-run batch record audit, data analysis, trending, and preparation of post-run debriefs
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Drafting and review of Bulk Drug Substance and Finished Product Stability studies
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Developing customized manufacturing training programs geared towards complex unit operations
Quality & Compliance
BPAI has a wealth of experience in the quality arena, from the development of GMP-based quality systems to the implementation of environmental and utility monitoring programs. Some of our services include:
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Auditing batch records, third party service providers, and material vendors
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Auditing quality systems to Health Canada, TGA, EMEA, and FDA regulations
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Developing intrinsically linked CAPA-based quality systems
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Quality control laboratory design, equipment sourcing, setup, and oversight
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GMP introductory training
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Drafting and review of regulatory documents
Scientific Research & Experimental Development
If you have developed a new product or manufacturing process, or improved upon an existing product or process in the last 18 months, you may qualify for the Scientific Research & Experimental Development (SR&ED) claim in partnership with Research Tax Services Ltd. We work with your staff to prepare all technical and financial-prescribed forms, and assist you in the event of an eligibility review by the Canada Revenue Agency (CRA).
Virtual Service Chain
In the complex biologics industry, there are very few individuals that truly offer a “one-stop-shop” for all the needs of a program from drug discovery through to toxicology, regulatory through to commercialization.
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We recognize that our experience is one cog in the very large wheel that represents your important program. That’s why we have ventured out to create a virtual service chain, with trusted partners you can access through BPAI who will bring their skills to the table to help your organization to push the project forward.
Scientific Research & Experimental Development
Bio-Process Triage is a client-customized service offered by BPAI that is designed to quickly and effectively help your organization with major bio-process challenges. Our team works collaboratively with your technical project team to find an acceptable path forward.
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Our services include the review, root-cause investigation, and troubleshooting of processes from cell culturing to fermentation, harvesting, downstream purification, and bulk formulation.
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We are available 24/7 to respond to your inquiries regarding:
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Analytical method review/investigation
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Process scale-up failure
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Process equipment or method validation failure
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Cell bank contamination or failure
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Quality and/or compliance failure