Pilot Production of the Institute of Bioorganic Chemistry

http://www.hopiboh.org/  
220141 Minsk, Academician Kuprevich, St., 5/3

Enzyme immunoassay kits

COUNTRY OF ORIGIN

Belarus

IDENTIFIER

BO12229

PUBLISHED

2024-11-23

LAST UPDATE

2024-11-23

DEADLINE

Linked profile in other language
Responsible
Dmitrii Ianushevskii
hopmang@adsl.by
Summary
The Unitary Enterprise "Pilot Production of the Institute of Bioorganic Chemistry" offers consumers Enzyme immunoassay kits to provide healthcare institutions with Belarusian-made diagnostic kits under a manufacturing agreement and is looking for partners interested in a distribution services agreement.
Description
IFA-SARS-CoV-2-NP-lgG is a kit for the qualitative determination of IgG antibodies to the nucleocapsid antigen of the SARS-CoV-2 coronavirus in human serum or plasma using the enzyme-linked immunosorbent assay.
IFA-SARS-CoV-2-NP-lgM is a kit for the qualitative determination of IgM antibodies to the nucleocapsid antigen of the SARS-CoV-2 coronavirus in human serum or plasma using the enzyme-linked immunosorbent assay.
IFA-T4-free is a kit of reagents for the enzyme-linked immunosorbent assay of free thyroxine in human serum.
IFA-ANTI-TG is a kit of reagents for the enzyme-linked immunosorbent assay of antibodies to thyroglobulin in human serum.
IFA-TSH is a kit of reagents for the enzyme-linked immunosorbent assay of thyroid-stimulating hormone in human serum.
IFA-ANTI-TPO – a reagent kit for the enzyme immunoassay of antibodies to thyroid peroxidase in human serum.
IFA-CORTISOL – a reagent kit for the enzyme immunoassay of cortisol in human serum.
IFA-PROGESTERONE – a reagent kit for the enzyme immunoassay of progesterone in human serum.
IFA-TESTOSTERONE – a reagent kit for the enzyme immunoassay of testosterone in human serum.
IFA-ESTRADIOL – a reagent kit for the enzyme immunoassay of estradiol in human serum.
IFA-PSA – a reagent kit for the enzyme immunoassay of prostate-specific antigen in human serum.
IFA-PSA-free – a reagent kit for the enzyme immunoassay of free prostate-specific antigen in human serum.
IFA-Microalbumin – a reagent kit for the enzyme immunoassay of albumin in human urine.
IFA-CA125 – a set of reagents for enzyme immunoassay of CA 125 in human blood serum.
IFA-FERRITIN – a set for enzyme immunoassay of ferritin in human blood serum.
IFA-PROGESTERONE-M – a set of reagents for enzyme immunoassay of progesterone in cow's milk.


Information is posted in  Album of promising developments of the NAS of Belarus organizations for the real sector of the economy (2023), p. 199-200. (in Russian)

The purpose and characteristics of Enzyme immunoassay kits for various purposes can be found on the company's website in the "Products" section.
Advantages and Innovations
Products of own manufacture.

The enterprise has a preferential amendment when participating in public procurement in accordance with the Law on Public Procurement, as a manufacturer and is the only manufacturer of RIA/IRMA kits in the Republic of Belarus.

The kits are competitive in price.

The kits have technical characteristics that meet the world level.

The developed production technology is environmentally friendly.

The kits have passed medical tests and state registration, approved for production, sale, and medical use.

The manufacturing technology and application meet modern requirements for medical products.
Stage of development
Already on the market
Funding source
State budged
Internal
IPR status
Exclusive rights
Secret know-how
Sector group
Agrofood
BioChemTech
Healthcare

Organization information

Type
Industry SME 50-249
Year established
1986
NACE keywords
C.21.20 - Manufacture of pharmaceutical preparations
Q.86.90 - Other human health activities
M.72.11 - Research and experimental development on biotechnology
M.72.19 - Other research and experimental development on natural sciences and engineering
M.74.90 - Other professional, scientific and technical activities n.e.c.
Turnover (in EUR)
10-20M
Already engaged in transnational cooperation
Yes
Additional comments
The Unitary Enterprise "Pilot Production of the Institute of Bioorganic Chemistry of the National Academy of Sciences of Belarus" was founded in 1986 as a specialized enterprise for the production of radioimmune kits for the diagnosis of various human diseases. Currently, it is a modern biotechnological enterprise with highly qualified personnel and a modern production and technical base that allows performing complex technological processes and producing high-quality products.

UE HOP IBOH NAS of Belarus" produces SARS-CoV-2-IgM/IgG Rapid Tests for the rapid detection of IgM and IgG antibodies to the SARS-CoV-2 coronavirus, which causes COVID-19.

Radioimmune kits are the main type of diagnostic products manufactured. They are intended for the diagnosis of thyroid diseases, assessment of the state of the reproductive system and endocrine-metabolic processes, and determination of tumor markers. The kits are equipped with solid-phase immunosorbents based on monoclonal antibodies and stabilized, ready-to-use liquid forms of standards and radioactively labeled drugs. In terms of analytical parameters and performance characteristics, these kits correspond to the best foreign analogues.

The enterprise, together with the Institute of Bioorganic Chemistry of the National Academy of Sciences of Belarus, develops and manufactures enzyme immunoassay kits of hormonal (for determining thyroid, steroid and pituitary hormones) and oncological profiles; kits based on lanthanide immunofluorometric analysis for prenatal and neonatal diagnostics.

The enzyme immunoassay kits of infectious profile produced by the enterprise on the basis of industrial cooperation are intended for diagnostics of syphilis, viral hepatitis B, C, ToRCH infections, AIDS and coronavirus.
Certification standards
The enterprise has implemented a quality management system for the production of diagnostic kits for in vitro diagnostics. In 2012, the company's quality management system was certified for compliance with the requirements of STB ISO 9001-2009 (certificate of conformity STB No. BY / 112 05 01.002 02704). In 2017, the company's quality management system was certified for compliance with the requirements of the international standard EN ISO 13485: 2012 (certificate No. 9124.IBCN).
Certification standards
The company has implemented and certified a quality management system for the production of in vitro diagnostic kits for compliance with the requirements of international standards ISO 9001 and ISO 13485.

The company is accredited as a scientific organization. Certificate of accreditation of a scientific organization dated 03/16/2023 No. 246.
Languages spoken
English
Russian

Information about partnership

Type of partnership considered
Distribution services agreement
Manufacturing agreement
Type and role of partner sought
Consumers interested in purchasing enzyme immunoassay kits to provide healthcare institutions with Belarusian-made diagnostic kits under a manufacturing agreement.

Partners interested in purchasing enzyme immunoassay kits to provide healthcare institutions with Belarusian-made diagnostic kits under a distribution services agreement.
Type and size of partner sought
> 500
251-500
SME 51-250
SME 11-50
SME <= 10
R&D Institution
University
Sole proprietor

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