Cell Therapy Manufacturing and Quality Control: Current Process and Regulatory ChallengesUdaykumar Kolkundkar1*, Sanjay Gottipamula2 and Anish S. Majumdar1
- *Corresponding Author:
- Udaykumar Kolkundkar
Stempeutics Research Pvt. Ltd, Akshay Tech Park, No: 72 & 73
2ndfloor, EPIP Zone, Phase-I Area,Whitefield, Bangalore, India
E-mail: [email protected]
Received date: July 04, 2014; Accepted date: September 06, 2014; Published date: September 08, 2014
Citation: Kolkundkar U, Gottipamula S, Majumdar AS (2014) Cell Therapy Manufacturing and Quality Control: Current Process and Regulatory Challenges. J Stem Cell Res Ther 4:230. doi: 10.4172/2157-7633.1000230
Copyright: © 2014 Kolkundkar U, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Mesenchymal stromal cells (MSC) are multipotent stem cells that have been isolated from multiple tissue sources and are currently being used to demonstrate their therapeutic efficacy against various clinical indications. Dramatic increase in the use of MSCs for tissue engineering applications and in regenerative medicine in past two decades raises an increasing demand for cGMP (current Good Manufacturing Practice) based large-scale manufacturing process of MSCs and characterization of these cells. The challenge is to assure the safety and high-quality of cells that will ultimately be therapeutically effective. GMP compliance processing such as cell culture, expansion and cryopreservation is mandatory for making the cell therapy effective. MSCs from various tissue sources should be cultured for scale-up according to regulatory compliance to optimize culture conditions and to ensure the safety of these manufactured cell populations. This review describes cGMP compliances and manufacturing process of bone marrow derived MSCs; specifically in the context of establishing the process flow and in-process controls for the manufacturing process. Importantly, this review highlights the current manufacturing challenges and opportunities for process improvisation and its relevance’s for MSCs therapeutics potential.