Services to develop biologic processes, including fermentation, cell culture and protein purification. Expertise in process technology transfer and scale-up manufacturing.
Strategic planning to bring biomolecules from research phase to regulatory submissions, with specific experience in monoclonal antibodies.
Implement lean manufacturing practices for cycle time and waste reduction. Continuous improvement with process monitoring and statistical analysis.
President
Dr. Alahari Arunakumari (Aruna) is an experienced Biologics Process Development professional with expertise in microbial and mammalian production systems through progressive biopharmaceutical industry career for 18+ years at Medarex, Bristol Myers Squibb and Enzon. Aruna has provided strategic, managerial and technical leadership in Biologics process and product development, especially for the production of Ipilimumab, the anti-CTLA4 human monoclonal antibody and more than 14 other protein therapeutics that have resulted in 10+ INDs across various phases of clinical trials. Several HuMab processes were developed and transferred to internal manufacturing facility and CMOs and their processes were validated at scale for launch and commercial manufacturing. Aruna has seven patents and three patent applications in cell culture and Mab purification processes.
Vice-President
Dr. Ganapathy Muthukumar (Kumar) is a global operations executive who has applied his knowledge and expertise to build companies and increase shareholder values in small and large companies across Biologics, Medical Devices and Research Products market. Kumar has developed and optimized processes for several biological and medical device companies and designed state of the art facilities for commercial manufacturing of these molecules. Kumar has managed a portfolio of 150+ products with an annual revenue of $150MM+. Kumar has worked to execute technical transfers, quality management initiatives, compliance management initiatives and regulatory interactions at various companies. Kumar has a proven track record of continuous process improvements and profit maximization through Lean manufacturing activities. Kumar has a PhD in Microbiology and achieved Certification as Regulatory Affairs Professional (RAC/RAPS), Quality Manager/Operational Excellence (ASQ), Quality Auditor (ASQ), Six Sigma Black Belt (ASQ) and Pharmaceutical GMP Professional (ASQ). Kumar has published more than 30 publications in peer reviewed journals and has one patent in protein purification process.