Lonza scientists have developed a new cell line construction process that delivers cGMP material in 14 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.
“This new clonal cell line construction process is a breakthrough that gives customers high-quality results faster than ever before” said Allison Vernon, Head of Lonza Biopharmaceuticals Mammalian R&D Services. “The One-Step program, as well as Lonza’s other cell line construction services, offers customers flexible solutions that meet their immediate needs.”
Leveraging the strengths of Lonza’s proprietary GS Gene Expression SystemTM, the 14-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.
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)
For more information, please contact our experts
+1 201 316 9200 (North America)
+41 61 316 8111 (Europe & Rest of World)
Lonza is one of the world's leading suppliers to the pharmaceutical, healthcare and life science industries. Its products and services span its customers’ needs from research to final product manufacture. Lonza is the global leader in the production and support of active pharmaceutical ingredients both chemically as well as biotechnologically. Biopharmaceuticals are one of the key growth drivers of the pharmaceutical and biotechnology industries. Lonza has strong capabilities in large and small molecules, peptides, amino acids and niche bioproducts which play an important role in the development of novel medicines and healthcare products. Lonza is a leader in cell-based research, endotoxin detection and cell therapy manufacturing. Lonza is also a leading provider of value chemical and biotech ingredients to the nutrition, hygiene, preservation, agro and personal care markets.
Lonza is headquartered in Basel, Switzerland and is listed on the SIX Swiss Exchange. In 2008, Lonza had sales of CHF 2.94 billion. Further information can be found at www.lonza.com.
For further Information:
Head Corporate Communications
Tel +41 61 316 8566
Fax +41 61 316 9566
Tel +41 61 316 8798
Fax +41 61 316 9798
Tel +41 61 316 8835
Fax +41 61 316 9835