We understand that the road to an efficient commercial manufacturing process starts with the right process development program. Our multi-disciplinary process development team is constantly focusing on economic viability, robustness, scalability and conformation to the regulatory requirements of the processes right from the beginning. Whether your process needs to be GMP or ISO Certified, our process development teams in Kourim, Czech Republic and Visp, Switzerland have some of the most extensive fermentation know-how in the industry, having developed over 100 processes, 25 of them large-scale.
Process Development Services:
- Strain Design and Selection
- Strain Characterization
- cGMP Cell Banking
- Fermentation and Recovery Development
- Refold Optimization
- Filtration and Chromatography Development
- Analytical Support
Lonza’s Microbiological Experience:
- A dozen other microbial species, including BSL-2 organisms
In addition to classic mutagenesis in combination with high throughput screening, Lonza has developed its own expression platform for E. coli development. Additionally, Lonza is involved as an industrial partner in a strain development program for Pseudomonas as production host. Yeast or fungal systems might be additional alternatives to prokaryotic hosts. For example, methylotrophic yeasts such as Pichia pastoris and Hansenula polymorpha have become highly efficient systems for the expression of heterologous genes.
Upon request, we can also develop a new strain or potentially further improve your existing production strain.
The safe and reliable preparation of cell lines is of great importance. It ensures the integrity of the product during its development and allows for consistency during commercial production. Establishing a cGMP master cell bank (MCB) and working cell bank (WCB) is considered the first critical step for quality microbial biopharmaceutical production. Lonza offers cGMP-compliant master and working cell banking services to customers who are using Lonza’s process R&D service platforms. Whether it is cell line development, individual cell bank characterization, or testing and storage services, our experienced team will be ready to meet your cell banking needs.
The Lonza Cell Banking Service:
- Newly established, dedicated cGMP facility
- Qualified and validated equipment
- Testing and control of all raw material
- Full documentation to control all activities and aid traceability
- QA management for supervising all quality relevant aspects
- Qualified for bio-safety level 1 and 2
- GMP clean room level grade A (at Lonza level 3) in C (at Lonza level 2) for open culture handling
- Shared glass ware area for media preparation GMP grade D (at Lonza level 2)
- ICH Q7 ICH Q5, and ICHQ6
Culture Control Testing
Lonza always tests the first, last and two randomly chosen vials of a cell bank for selected strain and culture features. Only cell lines that have been adequately characterized and tested are released for production.
The following standard tests are performed with selected MCCs and WCCs:
Culture Viability - Growth performance and living cell count
Strain Identity - Microscopic imaging, macroscopic inspection, MicroSeq ID analysis, and specific biochemical features and enzymatic activities, etc.
Genetic Stability - Mitotic marker retention (in vitro cell age during storage), plasmid preparation or rescue for restriction site mapping, target gene sequencing, and PCR and Southern Blot techniques to demonstrate the stability of recombinant co-integrates
Purity - Testing for adventitious bacteria, fungi and phage infection (the last on request or if suspected)
Use testing (only for WCBs) - Growth performance, product formation and product identity, and stability after expanded fermentation (in vitro cell age during cultivation)
To read more about the customer requirements for submission for this service, please download our Microbial Master Cell Banking Brochure.