Preview

Biological Products. Prevention, Diagnosis, Treatment

Advanced search

Recommendations on the certification of reference standards for structure identification of recombinant therapeutic proteins

https://doi.org/10.30895/2221-996X-2022-22-2-218-225

Abstract

Reference standards for structure identification of recombinant therapeutic proteins are essential for quality assessment of recombinant protein-based biotechnological medicinal products. The development and certification of such reference standards hold special relevance because of, firstly, the absence of international, national or compendial reference standards for a number of new or recently approved proteins and, secondly, the disruption of supply chains providing the biopharmaceutical industry of the Russian Federation with international reference standards. Moreover, international and national regulatory documents contain only general requirements for the procedure of reference standards certification but not the considerations specific to the standards for biotechnologicals’ structure identification, which vary with the production technologies for each individual active moiety. The aim of this work was to provide recommendations on the procedure for the development and certification of reference standards used to identify the structure of recombinant therapeutic proteins. These recommendations define 4 main stages of the procedure: stage 1 covers the development of requirements for the reference standard, including the justification of material and formulation choices, the elaboration of quality specifications, and the assessment of quality; stage 2 comprises the selection of analytical procedures and the establishment of the values for the certified parameters; stage 3 includes stability studies and shelf-life setting; and stage 4 involves the development of documentation for the reference standard. The paper dwells upon the scope of the stages, taking into account the specific considerations for recombinant therapeutic proteins and the use of reference standards. The recommendations are based upon the extensive experience in biotechnologicals testing and standardisation of the employees of the Scientific Centre for Expert Evaluation of Medicinal Products. These recommendations can provide a base for the establishment of protein-specific certification programmes for reference standards used in structure identification. This approach will allow for systematisation of the process for standards development and ensure the traceability of information and the validity of results. The reference standards certified in accordance with these recommendations can be considered primary standards, if necessary.

About the Authors

O. B. Ustinnikova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation

Olga B. Ustinnikova, Cand. Sci. (Biol.).

8/2 Petrovsky Blvd, Moscow 127051



R. A. Volkova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation

Rauza A. Volkova, Dr. Sci. (Biol.)

8/2 Petrovsky Blvd, Moscow 127051



A. A. Movsesyants
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation

Artashes A. Movsesyants, Dr. Sci. (Med.), Professor

8/2 Petrovsky Blvd, Moscow 127051



V. A. Merkulov
Scientific Centre for Expert Evaluation of Medicinal Products; I. M. Sechenov First Moscow State Medical University (Sechenov University)
Russian Federation

Vadim A. Merkulov, Dr. Sci. (Med.), Professor

8/2 Petrovsky Blvd, Moscow 127051
8/2 Trubetskaya St., Moscow 119991



V. P. Bondarev
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation

Vladimir P. Bondarev, Dr. Sci. (Med.), Professor

8/2 Petrovsky Blvd, Moscow 127051



References

1. Bondarev VP, Borisevich IV, Volkova RA, Fadeykina OV. Industry reference standards certification for the control of medical immunobiological preparation. Vedomosti nauchnogo centra ekspertizy sredstv medicinskogo primeneniya = Scientific Center for Expartise of Medical Application Products Bulletin. 2013;(2):28–32 (In Russ.)

2. Volkova RA, Fadeikina OV, Klimov VI, Sakanyan EI, OlefirYuV, Merkulov VA, et al. Topical issues related to reference standards in the sphere of circulation of biological products. Biopreparaty. Profilaktika, diagnostika, lechenie = BIOpreparation. Prevention, Diagnosis, Treatment. 2016;16(4):229–36 (In Russ.)

3. Fadeikina OV, Volkova RA. Elaboration of certification procedures for reference standards of biological drugs. Khimiko-farmatsevtichesrii zhurnal = Pharmaceutical Chemistry Journal. 2017;51(8):44–50 (In Russ.) http://doi.org/10.30906/0023-1134-2017-51-8-44-50.

4. Volkova RA, Fadeikina OV, Ustinnikova OB, Sakanyan EI, Merkulov VA, Movsesyants AA, et al. Current problems with the standard samples of medicines in the Russian Federation. Farmaciya = Pharmacy. 2020;69(2):5–11 (In Russ.) https://doi.org/10.29296/25419218-2020-02-01

5. Goloshchapova EO, Runova OB, Ustinnikova OB. Recombinant human interferons beta-1a and beta-1b: protein structural features and problematic issues of identity confirmation. Khimiko-farmatsevtichesrii zhurnal = Pharmaceutical Chemistry Journal. 2018;52(8):61–4 (In Russ.) http://doi.org/10.30906/0023-1134-2018-52-8-61-64

6. Shvedova EV, Ustinnikova OB, Rounova OB, Volkova RA, Bondarev VP, Smolov MA, et al. The development of industry standard sample qualification procedure of recombinant activated blood clotting factor VII for proving of identity by peptide mapping method. Gematologiya i transfuziologiya = Russian Journal of Hematology and Transfusiology. 2018;63(4):334–42 (In Russ.) https://doi.org/10.25837/HAT.2019.68.74.002

7. Ustinnikova OB, Rounova OB, Movsesyants АА, Shukurov RR, Smolov MA, Khamitov RA. Evaluation of N-glycosylation profile of recombinant blood coagulation factor VIIa molecule. Molekulyarnaya medicina = Molecular Medicine. 2020;18(4):50–5 (In Russ.) https://doi.org/10.29296/24999490-2020-04-08

8. Ustinnikova OB, Goloshchapova EO, Runova OB, Korotkov MG, Volkova RA. Development of a qualification procedure for methionine form of interferon alfa-2b standard to confirm its authenticity by means of a peptide mapping method. Medicinskaya immunologiya = Medical Immunology (Russia). 2018;20(4):543–50 (In Russ.) https://doi.org/10.15789/1563-0625-2018-4-543-550


Supplementary files

Review

For citations:


Ustinnikova O.B., Volkova R.A., Movsesyants A.A., Merkulov V.A., Bondarev V.P. Recommendations on the certification of reference standards for structure identification of recombinant therapeutic proteins. Biological Products. Prevention, Diagnosis, Treatment. 2022;22(2):218-225. (In Russ.) https://doi.org/10.30895/2221-996X-2022-22-2-218-225

Views: 874


Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.


ISSN 2221-996X (Print)
ISSN 2619-1156 (Online)