Client Case Studies
With an accomplished staff that boasts decades of biopharmaceutical industry experience, BioTechLogic, Inc. has helped numerous clients bring biopharmaceutical products to market. These case studies offer a glance at some recent successes—and how we worked as a team with our clients to achieve them.
Technology Evaluation
BioTechLogic performed a technology evaluation for a drug substance manufacturer located in Basel, Switzerland to evaluate the commercial process for the U.S. market. The original submission filed with the FDA was being held up, and had numerous observations linked to the manufacturing process. BioTechLogic performed an assessment of the development work, the technology and the manufacturing process, and a comprehensive plan was put together to address the observations. The plans included: additional characterization at in-process steps, the addition of process controls, processing changes and analytical method changes.
Technology and Facility Evaluation
BioTechLogic performed a technology and facility evaluation for a potential drug product manufacturer located in Bombay, India to produce clinical supplies for studies being conducted in the U.S. and Canada. The manufacturer had the formulation technology in-house, and would therefore be able to meet the client's aggressive timelines. BioTechLogic performed an assessment of the facility, equipment, and process, as well as an assessment of the qualification/validation status of each. A remediation plan and associated Project Plan and Schedule were then assembled. The major areas of remediation included: environmental monitoring, gowning, operations in classified areas, media fill procedures and process validation.
PAI Readiness Effort
A client was preparing for the validation, submission and pre-approval inspection of a facility, process and product estimated to be a "blockbuster" drug, if approved. As part of the PAI readiness effort, the product sponsor hosted several "Mock PAIs" that resulted in significant observations spanning the process, product and facility. BioTechLogic developed a risk ranking tool that categorized each observation, ranked them by severity and probability of occurrence, and developed the plan for remediation.
The outcome of the risk ranking exercise yielded five major areas for immediate remediation: Technical Development (Synthesis, PEGylation, Purification), Environmental Monitoring and Controls, CAPA and Open Investigations, Critical Facility and Utility Systems, and QC Lab Practices. BioTechLogic developed the remediation plan involving multi-disciplinary teams and various contract companies to establish the deliverables and drive the process to completion.
Technology and Facility Evaluation
BioTechLogic performed a technology and facility evaluation for a drug substance manufacturer located in Bangalore, India to produce initial clinical and commercial supplies for the U.S. and Canada. The manufacturer was already producing drug substance for distribution in local markets. BioTechLogic performed an assessment of the facility, equipment and process, as well as an assessment of the qualification/validation status of each. A remediation plan and associated Project Plan and Schedule were then assembled. The major areas of remediation included: raw material and cell bank, process parameters and controls, process validation, analytical characterization, equipment qualification, utility qualification and process flow.
International Inspection Readiness Program
BioTechLogic developed and implemented an international inspection readiness program and Bio-validation strategy for a Global Supply Chain that supported the approval of Somavert® by the FDA (CDER) in March 2003 and by EMEA in May 2003, followed by approvals in Canada and Japan. Supply chain sites included a new drug substance manufacturing site (no prior FDA or EMEA experience), a new analytical and stability lab (no prior FDA or EMEA experience), a drug product manufacturing site with extensive experience with FDA and EMEA, and several additional support analytical laboratories with FDA experience.
BLA Submission
A client was preparing for the BLA submission of a product estimated to have a significant edge over similar products already on the market, if approved. BioTechLogic prepared the CMC sections (Module 3 and Module 2, Quality Overall Summary) for the initial indication ahead of the target submission date. FDA review of the CMC sections resulted in only minor questions. As a result, the product sponsor contracted BioTechLogic to write the CMC sections for subsequent indications for submission in both the U.S. and E.U. Additionally, BioTechLogic developed the strategy and plan for the subsequent submissions and provided project management leadership for the various cross-functional teams charged with delivering the BLA/MAA.
Process Validation
A client headquartered in the U.K. was preparing to validate a drug product process which was being manufactured at a contract manufacturing site in the U.S. The client engaged BioTechLogic to provide U.S.- based manufacturing support at the contract manufacturer. BioTechLogic performed an assessment of the qualification/validation status of the facility, equipment and process and then developed and executed the overall validation strategy and associated Project Plan and Schedule.
The major areas of the process validation included: mixing, hold time, dosage form uniformity and lyophilization studies; container closure integrity; equipment qualification; and process validation protocols. An analytical strategy and sample flow was also put together to address testing at multiple testing labs, including the contract site, the client's U.S. site, and a contract testing laboratory in Germany. As an outcome of this project, BioTechLogic wrote the related BLA submission sections: Pharmaceutical Development including formulation and lyophilization development; Manufacture including Manufacturing Process and Process Controls; Controls of Critical Steps and Intermediates; and Process Validation.