Development of Microbial and Mammalian based Biosimilars
Vitane Biologics provides very robust, efficient, high quality upstream and downstream process development services. Our expertise provides high-end scientific and technical excellence to process development in upstream, downstream and analytical techniques. We also provide the services from laboratory design, facility design, and its setup through process development till commercialization of products. We offer following services
• Selection of clones
• Development of reproducible and robust process
• Optimization studies
• Process control strategies
• Identification of critical process steps
• Technology transfer package and documentation
Production services under cGMP
Bacterial/Yeast/Mammalian platform
Vitane Biologics state-of-the-art single use platform offers a broad range of cGMP biopharmaceutical manufacturing services for preclinical, clinical and commercial supply.
Vitane Biologics expert team has capability to produce high quality material to match global requirement in bio-therapeutics. Our cGMP disposable platform manufacturing facility meets global regulatory requirements and provides maximum flexibility and shortens process time.
Bacterial/yeast platform
• Fermentation optimization at 5 lit to 2000 L scale
• Comprehensive purification solutions (refolding, chromatography, membrane processes, tangential flow filtration processes).
Mammalian platform (end-to-end single use platform)
• Bioreactor at 5 lit to 500 liter scale
• Purification by high end chromatography systems
• Viral clearance
Aseptic Fill & Finish under cGMP
• Formulation and final Drug Product manufacture
• Two automated filling lines for vials, cartridges and prefilled syringes
• Lyophilisation
• Packaging
Analytics:
Vitane Biologics provides integrated analytical Quality Control services to support Drug Substances and Drug Product release. Our QC-laboratory complies with the GLP standards and we provide following services
• Product specific assays
• Impurity analysis
• Cell based assays
• Microbiological QC and safety assays (Sterility, Bioburden, Endotoxin etc.)
• Method validation
• Lot release testing and characterization
Collaborative services:
Vitane Biologics offers process development services as per client needs: full turn-key development or technology transfer based process adaptation to meet cGMP requirements. Our services include development of cell culture, fermentation and purification processes aiming for cGMP manufacturing of biopharmaceuticals. The Company also provides linear scale-up from laboratory to full cGMP production aiming for higher quality and cost efficiency.
Sister Company
Vitane Pharma GmbH, Pfaffenrieder Str. 7, D - 82515 Wolfratshausen, Germany - info@vitanepharma.com
Vitane Biologics Private Limited is a Vitane Group Company