Skip to main content
SpringerLink
Log in

Specificity of Good Manufacturing Practice (GMP) for Biomedical Cell Products

  • Translated from Kletochnye Tekhnologii v Biologii i Meditsine (Cell Technologies in Biology and Medicine)
  • Published:
Bulletin of Experimental Biology and Medicine Aims and scope

The article describes special aspects of Good Manufacturing Practice (GMP) for biomedical cell products (BMCP) that imply high standards of aseptics throughout the entire productio process, strict requirements to donors and to the procedure of biomaterial isolation, guaranty of tracing BMCP products, defining processing procedures which allow to identify BMCP as minimally manipulated; continuous quality control and automation of the control process at all stages of manufacturing, which will ensure product release simultaneously with completion of technological operations.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. GOST R ISO 14644-1-2002 Clean Rooms and Associated Controlled Environments. Part 1. Clean Air Classification. Moscow, 2003. Russian.

  2. GOST R ISO 13408-6-2009 Aseptic Manufacturing of Medical Preparation. Part 6. Insulating Systems. Moscow, 2009. Russian.

  3. GOST R ISO 9001-2011. International Standard of Quality Management System. Requirements. Moscow, 2012. Russian.

  4. On biomedical cell products: Federal Law No. 180-FZ, June 23, 2016. Ross. Gazeta. 2016;(139):18. Russian.

  5. OST 64-02-003-2002. Products of the Medical Industry. Technological Regulations of Production. Contents, Procedure of Development, Endorsement, and Approval. Moscow, 2002. Russian.

  6. Pyatigorskaya NV, Tulina MA, Aladysheva ZhI, Beregovykh VV. International approaches to the regulation of cell therapy products. Vestn. Rioss. Akad. Med. Nauk. 2013;(8):4-8. Russian.

  7. Carmen J, Brindley DA, Davie NL, Smith D. Cell therapy manufacturing: identifying and meeting demand. Stem Cells in Regenerative Medicine: Science, Regulation and Business Strategies. Vertes AA, Qureshi N, Caplan AI, Babiss LE, eds. Chichester, 2015. P. 49-68.

  8. Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of GMP in respect of medicinal products for human use and investigational medicinal products for human use. Official Journal of the European Union. 2003;L262:22-26.

  9. Commission Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. Official Journal of the European Union. 2005;L102:48-58.

  10. Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). FDA. 2011. P. 67.

  11. Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). FDA. 2007. P. 70.

  12. Guidance for Industry: Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated Solely under Section 361 of the Public Health Service Act and 21 CFR Part 1271. FDA. 2015. P. 20.

  13. Guideline on Human Cell-Based Medicinal Products. EMEA. 2008. P. 24.

  14. Guideline on Risk Management Systems for Medicinal Products for Human Use. EMEA. 2005. P. 32.

  15. Günther Ch. Huss R, Hauser A. Advances in Pharmaceutical Cell Therapy: Principles of Cell-Based Biopharmaceuticals. Singapore, 2016.

  16. ISBT 128 Standard. Labeling of Cellular Therapy Products. ICCBBA, 2013. ST-004. P. 39.

  17. Kellathur SN, Lou HX. Cell and tissue therapy regulation: worldwide status and harmonization. Biologicals. 2012;40(3):222-224.

    Article  PubMed  Google Scholar 

  18. Kolkundkar U, Gottipamula S, Majumdar A. Cell therapy manufacturing and quality control: current process and regulatory challenges. J. Stem Cell Res. Ther. 2014;4(9):75-82.

    Article  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Institute of Pharmacy and Translational Medicine, I. M. Sechenov First Moscow State Medical University, Ministry of Health of the Russian Federation, Moscow, Russia

    M. A. Tulina & N. V. Pyatigorskaya

Authors
  1. M. A. Tulina
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. N. V. Pyatigorskaya
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to M. A. Tulina.

Additional information

Translated from Kletochnye Tekhnologii v Biologii i Meditsine, No. 4, pp. 268-272, October, 2017

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Tulina, M.A., Pyatigorskaya, N.V. Specificity of Good Manufacturing Practice (GMP) for Biomedical Cell Products. Bull Exp Biol Med 164, 579–582 (2018). https://doi.org/10.1007/s10517-018-4035-8

Download citation

  • Received:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10517-018-4035-8

Key Words

Search

Navigation