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Process Development Services |
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| 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 right from the beginning The services we offer include: − Strain design and selection − Strain characterization − cGMP cell banking − Fermentation and recovery development − Refold optimization − Filtration and chromatography development − PEGylation development − A full range of analytical development support − XSpedite Microbial Services™ for proof-of-concept studies − 20L express cGMP production for toxicology and phase I clinical material Research and development activities for Microbial Biopharmaceuticals take place in Visp, Switzerland, and in Hopkinton, Massachusetts (USA). Our experts work in dedicated multi-disciplinary project teams, integrating customer’s requirements at every stage of the project. Microbial Biopharmaceutical services are fully integrated from the development of new or existing lab-scale processes, through clinical supply, to full-scale commercial production. |
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Strain Design - In addition to classic mutagenesis in combination with high throughput screening, Lonza has developed its own expression platform for Escherichia coli. Additionally, Lonza is involved as an industrial partner in a strain development program for Pseudomonas as production host in the framework of an international EU project. 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, Lonza can also develop a new strain or is prepared to further improve a customer’s existing production strain. Cell Banking - Lonza Custom Manufacturing has dedicated cGMP units within the manufacturing facilities to create Master and Working Cell Banks for subsequent production. For safety reasons, dual-site, cGMP cell bank storage is offered to all customers. In addition, Lonza Custom Manufacturing offers cell line characterization services and full documentation that meets regulatory standards. |
