Optimize Now and Remove Future Obstacles
Lonza understands 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. We are thinking ahead so you can minimize future obstacles.
Our experts work in dedicated multi-disciplinary project teams, integrating customer’s requirements at every stage of the project. Our technical team has access to state-of-the-art expression systems and years of optimization experience with these various microbial systems. Our proprietary XS Microbial Expression Technologies™ allow you to select the optimal host for your gene of interest. However, if the traditional E.coli systems are the leading platform selection for your target, Lonza’s development team has a solid track record in this field.
Figure 1: Therapeutic protein levels achieved with Lonza’s E.coli systems.
Microbial Biopharmaceutical Services are fully integrated from the development of new or existing lab-scale processes, through clinical supply, to full-scale commercial production.
Fermentation Recovery and Development
Our fermentation specialists are prepared to maximize your yield while maintaining the highest quality product. Process optimization is the fundamental key to reducing potential pitfalls such as inclusion body expression and improper refolding. Our experience with upstream optimization techniques and materials allows us to produce the most functional protein or pDNA candidate.
Lonza’s Fermentation Expertise Include:
- Fermentation Development
- Feed Strategy Optimization
- Media Optimization
- Induction Kinetics Optimization
- Recovery and Separation Development
- Inclusion Body Expression Optimization
- Inclusion Body Refold Development
- High Cell-density Fermentation
Purification and Refold Development
High yield production of your lead protein or pDNA candidate is just the beginning to a successful final product. At Lonza, we continue our quest for excellence with superior downstream purification and refolding. Our years of TFF process optimization and PEGylation techniques will give you the best chance to speed up your development time.
Lonza’s Downstream Purification Offering Includes:
- Filtration & Chromatography Development
- Resin Screening
- TFF for purification, concentration & buffer exchange
- Impurity Removal Studies (endotoxin, residual DNA
- Bulk Formulation Development
- PEGylation / HESylation Development & Optimization
- Evaluating alternatives to chromatography
Process Validation Support
Any final process for development and production requires complete validation support. Successful scale-up and product release is dependent on a successful validation run. Our process validation team will prepare your process for small-scale cGMP production to take you to the clinic faster.
Lonza’s Validation Services Include:
- Scale-Down Modeling
- High Throughput Characterization
- Critical Process Parameter Studies
- Range Finding Studies
- Analytical Method Validation
- Automated Equipment
- Media & Buffer Stability
- In-Process Hold Studies
- Resin & Filter Re-use Studies
Validated analytical methods are available to support the early release of your product into the clinic. Our analytical team has a wide-range of testing expertise to support all types of microbial products.
Lonza’s Range of Analytical Services Include:
- HPLC Assays (SEC/RP/IEX)
- Gel Electrophoresis (Native, SDS-PAGE, agarose)
- Immunoassays (Western Blot, ELISA)
- Protein & Spectrophotometric Assays
- Bioassay Development Services (US & Europe)
- Wet Chemistries
- GC, IR, NIR, NMR, LC-MS, RID
- Electron Microscopy
- Sulphate Ash, XRD, ICP-OES (elementary analysis), Heavy Metals
- Microbiologic Assays
- Bioburden, Viable Cell Counts, Plasmid Stability
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. We offer 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 ICH Q6
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
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.