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| Lonza's global research and development center for mammalian cell culture is based in Slough, UK (near London’s Heathrow airport). The development team is organized in three departments: Cell Culture Process Development, Purification Development and Analytical Development. The departments work closely together to coordinate their activities and to develop processes for manufacturing. |
Accelerated Clonal Cell Line Constructions
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Lonza scientists have developed a new cell line construction process that delivers cGMP material in 13 months from the receipt of DNA sequence, using rapid methods for generating clonal cell lines.
Called “One-Step,” this customer-tailored cell line construction process uses chemically defined, non-animal origin components. It includes cell line stability testing, stringent selection to isolate high-yielding cell lines, procedures and datapack to support monoclonality, regulatory support, and the same Lonza quality customers trust.
Leveraging the strengths of Lonza’s proprietary GS Gene Expression System™, the 13-month One-Step program can be further tailored to suit customers’ project and timeline requirements. Lonza also offers cGMP material from uncloned cell lines for early phase use in 11 months from receipt of DNA sequence and material for proof-of-concept studies from pooled transfectants in 4 months.
WATCH a recent presentation titled "Faster and More Efficient Cell Line Development for cGMP Manufacturing," delivered by Dr. John Birch, former CSO of Biopharmaceuticals, and Dr. Andy Racher, Senior Principal Scientist, Cell Culture Process Development.
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Typical One-Step Package |
| - Chemically defined, non-animal origin process
- Monoclonal cell line construction
- Screening to select high producing cell lines
- Procedures and datapack to support monoclonality
- Cell line stability testing
- Regulatory support
Other Cell Line Construction Programs (DNA to cGMP)
Two-Step Clonal CLC: 18 months
(for all clinical phases and commercial supply, up to 5.5 g/L for antibodies)
Fast Track Uncloned CLC: 12 months
(for early clinical phases, up to 5.5 g/L for antibodies)
Fast Track Express Uncloned CLC: 11 months
(for early clinical phases, up to 4 g/L for antibodies)
Proof of Concept: 4 months
(from pooled transfectants) |
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