The Foundation of Your Process
Lonza's Cell Culture & Process Development team has over 25 years of experience in the development of production processes for animal cell products. A wide range of cell types, (e.g. CHO, hybridomas, various mouse myeloma and human cell lines) have been used to produce monoclonal antibodies (mAbs) and other recombinant proteins using a variety of expression systems.
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Cell Line Construction
A key factor in reducing the production costs of biopharmaceuticals is the development of cell lines producing a high yield of product. For recombinant monoclonal antibodies (mAbs) and proteins, Lonza can create vectors to express product using the GS Gene Expression System™ technology. Antibody yields of up to 10 grams/liter have been achieved using this system in chemically defined, animal-, component-free medium. Our customers' products can be expressed in either CHO or NS0 cells. The selection strategy has been designed to identify cell lines that are highly productive and have the ability to grow well in suspension culture in a state-of-the-art, fed-batch fermentation process.
The selection of cell lines compatible with production requirements can lead to significant time savings at later stages. In addition, close interaction with regulatory authorities worldwide ensures that the cell lines will be constructed, cloned and characterized according to current regulatory guidelines.
Accelerated Clonal Cell Line Construction
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 Cell Line Construction,” this customer-tailored 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 our mammalian expertise, the 13-month One-Step Program can be further tailored to suit customer's 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.
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)
Mammalian Cell Banking
A dedicated cGMP unit within our licensed UK manufacturing facility is used to create master and working cell banks for subsequent manufacturing use. The cell banks are characterized in accordance with FDA and European regulatory agency requirements. For safety and security considerations, dual-site storage of all cell banks are maintained between our US and UK facilities.