Cell lines programs with commercialization and your priorities in mind
Creating cell lines with future manufacturability, cost of goods and speed in mind is of critical importance in today’s biopharmaceutical development. By working with our cell culture teams in our Slough (UK), Visp (CH), and Tuas (SG) sites, you will benefit from a recognized and stable cell line using our GS Xceed® Gene Expression System.
> 35 years of experience
800+ cell lines taken to GMP manufacture
Over 145 IND/IMPD filling supported
The combination of host cell line, vector and stringency of selection enables us to provide our customers with high producing cell lines suited to fit a commercially relevant platform process.
Percentage of cell lines above different titer levels
Your cell line will be developed using procedures based on achieving high product titers and the desired product characteristics. Selection experiments carried out in miniature bioreactors with an abridged version of our platform manufacturing process will help to reduce risks at later stages and allow a seamless transition from development into cGMP manufacturing. Close interaction with regulatory authorities worldwide eases regulatory hurdles since these cell lines will be constructed, cloned and characterized according to current regulatory guidelines. To date , we have supported over 145 IND/IMPD. Finally, the use of electronic notebooks enables real time data entry, reduces human error and offers full traceability.
Speed matters but so does the big picture
At Lonza, you can benefit from a flexible approach to cell line development that matches your priorities in terms of timelines, yield optimization and risk. Our team will discuss options in detail to determine the best scope to fit your project requirement and will offer customized programs.
To explore our cell line development offerings, click on the appropriate box below:
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.
Achieving the appropriate product characteristic profile
Protein Sequence Variant Analysis
A protein sequence variant is an unintended amino acid sequence change within a region of a product. Any biological expression system is prone to generation of these variants, which may affect (inter alia) product efficacy and immunogenicity. Traditionally, detailed analysis of product variants is performed during Phase II/III of development once cell line and manufacturing process has been fully defined. This is usually performed as part of the reference standard characterization studies which are required for regulatory submissions. However this traditional, reactive approach provides no effective options should an issue be identified – either the process must be redeveloped or a different cell line taken forward. These options carry significant unforeseen costs and timeline impact.
In contrast, incorporation of advanced analytical tools into cell line development enables early, proactive detection of protein variants. Since variants may be generated during translation of mRNA in the ribosome, effective detection must be performed at the protein level rather than by DNA or mRNA sequencing alone. Our Protein Sequence Variant Analysis (PSVA) platform uses class-leading mass spectrometry methods including Electron-Transfer Dissociation and Ultra-High-Resolution Orbitrap mass detection. Our scientists apply advanced informatics to rapidly detect and quantify any amino acid substitutions in panels of candidate cell lines, or across processes.
This technology allows consistent detection of variants across the entire product sequence. Variants at levels as low as 0.004% have been confidently identified.