Strategic consulting in biologics process development, CMC strategy, and manufacturing operations — backed by 50+ years of combined industry expertise.
Our consulting services are founded in 50+ years of industry experience in biologic processes.
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.
Dr. Alahari Arunakumari (Aruna) is an experienced Biologics Process Development professional with expertise in microbial and mammalian production systems through a progressive biopharmaceutical industry career spanning 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. She holds seven patents and three patent applications in cell culture and Mab purification processes.
Dr. Ganapathy Muthukumar (Kumar) is a global operations executive who has applied his knowledge and expertise to build companies and increase shareholder values across Biologics, Medical Devices and Research Products markets. Kumar has developed and optimized processes for several biological and medical device companies and designed state-of-the-art facilities for commercial manufacturing. He has managed a portfolio of 150+ products with annual revenue of $150MM+, executing technical transfers, quality management, and regulatory interactions. Kumar holds certifications as a Regulatory Affairs Professional (RAC/RAPS), Quality Manager/Operational Excellence (ASQ), Six Sigma Black Belt (ASQ), and Pharmaceutical GMP Professional (ASQ), with 30+ publications in peer-reviewed journals and one patent in protein purification.
Whether you need process development guidance, CMC strategy, or manufacturing optimization — we're ready to help.