BioRox® Inc.
Life Is Great, Let's Make It Even Better!
Welcome to BioRox® Inc., a cell & gene therapy and biologics CMC consulting company. Experienced in all phases of development and manufacturing as well as lab and facility design.
Services
BioRox® Inc. services cover the full range of CMC activities over the lifecycle of biologics and advanced biological therapies (e.g. Gene and Cell Therapies). We support CMC and related functions beginning in early product design through successful commercialization.
Example Projects
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Implemented QbD principles into late-stage gene therapy process development
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Provided CMC strategy for client considering a gene therapy program
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Assisted pre-clinical stage gene therapy client with CMC requirements
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Assessed the needs of a program and defined the R&D and GMP material supply strategy, including evaluating CDMOs
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Designed a clinical manufacturing facility, including specifying equipment, organizational structure and resource requirements
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Compiled the relevant research and process characterization reports into the CMC sections of 2 BLAs, which were subsequently approved
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Provided an operation perspective to an equipment designer for their new PAT system
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Managed all aspects of CMC for a virtual company
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Audited facility for QP audit rediness
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Assisted several clients in selecting and managing CDMOs
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Assessed and designed plasmid sequences for AAV production
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Conducted several due diligence assessments for investors and potential client acqusitions
Team Expertise
Our team has extensive experience in diverse areas such as overall quality assurance, analytical method development, molecular biology, DNA sequence analysis, process development, GMP manufacturing, regulatory strategy and project management to provide a high quality approach to client projects. In addition, we can provide support for non-clinical and clinical quality assessments.
Leadership
Jennifer Ton, President and Founder
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BS Bacteriology, University of Wisconsin-Madison
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MS Biology, Biotechnology Core, Illinois Institute of Technology
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30+ years in biopharma process development and manufacturing
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Led development of over 30 bioprocesses that have been scaled to clinical and/or commercialized
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Contributed to multiple regulatory filings, at all phases
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Interacted directly with multiple regulatory agencies
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Provided process development and MSAT support for botulinum neurotoxin and additional biologics
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Led viral vector manufacturing platform process development, upstream manufacturing, fill/finish operations and plasmid manufacturing
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CMS support for multiple clients ranging from start-up to commercialization
