About
1099 BioServices was founded by Dr. Christopher Dale as a full consulting service to the Biotechnology industry with emphasis on Biopharmaceutical process development and GMP manufacturing (Phase I, II, III and commercial manufacturing). 1099 BioServices provides expertise in expression of recombinant products (proteins, peptides and pDNA) using microbial fermentation, mammalian cell culture together with recovery/clarification and downstream processing technologies.
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1099 BioServices provides full lifecycle expertise and management of outsourced projects from CMO/CDMO screening and selection, SOW development, technology transfer, technical and project oversight.
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Our extensive technical expertise an be leveraged for success at all stages of biopharmaceutical lifecycles (innovator and biosimilar). Expert witness services are available to support customers engaged in litigation matters.
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Key links
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https://www.linkedin.com/in/chris-dale-0195015/
Services
Technology Services
CMC Services
Expert Services
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Bioprocess design (design for manufacturing)
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Facility design and equipment selection
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Expression vector and host selection
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Fermentation strategies (high cell density bacterial and yeast cultures)
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Cell culture systems and media selection
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Centrifugation and Microfiltration
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IB recovery, solubilization and refolding
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Downstream processing (column chromatography, TFF, NF, precipitation, ATPS)
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Bulk drug substance formulation
CTD Module 2 and 3
Process characterization
Process validation
VMP
Process development reports and summary documents
Expert witness
Deposition and evidence preparation
Quality systems support
Document review and correction
Authorship of draft documents for your quality system (deviation resolution, risk based assessments, regulatory submissions - dossier variations
CMO/CDMO Services
CMO/CDMO screening and selection
RFP and response evaluation
Contract evaluation
Technology transfer of your process to CMO/CDMO
Process development
Analytical development
Technology transfer to GMP manufacturing
Manufacturing support (technical and quality)
Interested in Consulting Services ?
Contact 1099 BioServices using the response form below
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Services : Outsourcing with CMO/CDMOs
Outsourcing with CMO/CDMOs requires careful planning throughout the entire lifecycle to ensure projects maintain on-time, on-budget delivery.
We support our customers at all stages of the outsourcing lifecycle
Interested in Outsourcing Support ?
Contact 1099 BioServices using the response form below
Contact
1099 Bio Services
Located in New England, USA