Dr. Thirumala’s laboratory has expertise and experience with:
- Development of optimized cGMP compliant processes, tools and protocols for therapeutically effective cells.
- Establishing 2-tier (MCB, WCB) or 3-tier (pMCB, MCB, WCB) cell banks for continuous availability of cells with defined cell characteristics. The cell banks will be characterized for identity and potency and will be tested extensively for sterility and viruses.
- Large-scale manufacturing using bioreactors for adherent and suspension cells such as stem cells and Immune Cells. Currently Dr. Thirumala’s laboratory is equipped with state-of-the-art bioreactor systems such as BioBlu® (Eppendorf, USA) stirred suspension bioreactor, PBS (PBS Biotech, USA) low-shear bioreactor, and WAVE® (GE Healthcare, USA) bioreactor systems for studying both adherent and suspension cellular systems.
- Process optimization for culture media development, as well as custom manufacturing and packaging at any scale—from 0.3-100 L
- Cell therapy product biopreservation, packaging, banking and sample transportation using high quality, state-of-the-art technologies and methodologies for all critical temperature-controlled steps in cell therapy workflow
- Development and characterization of advanced biomimetic tissue-engineered technologies including clinical scale production of cell spheroids, and multi-dimensional cell sheet technologies
- Development of cell conditioned media compositions having valuable biological activity and development of exosome based therapeutics.
- Implementation of innovative methods such as Quality by Design and Process Analytical Technologies when needed to ensure consistent product quality
- QA/QC and regulatory experience for the development of products and compliance with FDA regulations
- Training investigators, fellows and technical staff in cell isolation, processing, characterization, expansion, and biopreservation
Woods EJ*, Thirumala S, Badhe-Buchanan SS, Clarke D, Mathew AJ. Off the shelf cellular therapeutics: Factors to consider during cryopreservation and storage of human cells for clinical use. Cytotherapy. 2016 Jun; 18(6):697-711.
Jawed, B. Johnstone, S.Thirumala, K.March. Tissue-Derived Non-Hematopoietic Stem Cell Sources for Use in Cell-Based Therapies. AABB Technical Manual pp: 753-772. 2014
Thirumala, W. S. Goebel and E. J. Woods. Manufacturing and Banking of Mesenchymal Stem Cells. Expert Opinion on Biological Therapy, Early Online:1-19 (2013)
Thirumala, J.M. Gimble and R.V. Devireddy. Methylcellulose Based Thermally Reversible Hydrogel System for Tissue Engineering Applications. Cells 2013, 2(3), 460-475
E.J. Woods, S. Thirumala, X. Han, and J. Crister. Fundamental Cryobiology of Reproductive Cells and Tissues: Concepts and Misconceptionss. In: “Principles and Practice of Fertility Preservation”, edited by Dr. Donex and Dr. Kim, Cambridge University Press , pp. 129-144, 2011.