FDO Accredited Laboratory
The first laboratory for analysis and quality control of biological and recombinant products in Iran
ArcBioAssay
Under the guidelines of Good Manufacturing Practice (GMP), a pharmaceutical product must undergo multiple tests to ensure its purity, concentration, stability, identity, and safety before being released into the market. Importantly, this scrutiny extends beyond the initial market entry, necessitating ongoing monitoring and testing of biological drugs.
Quality control testing, along with the preparation and evaluation of relevant documentation, is a resource-intensive process. It demands significant time, skilled personnel, and specialized equipment. Therefore, it is advisable to entrust these responsibilities to expert reference laboratories.
Arcbioassay Company stands out as Iran’s premier laboratory specializing in quality control for biological and recombinant products. As a partner laboratory of the Food and Drug Organization, Arcbioassay is equipped with state-of-the-art technology and a team of proficient professionals. The company offers comprehensive quality control services for biological products. These services encompass various stages, including research and development, initial drug market entry, and periodic drug quality checks once in the market. Possessing laboratories for molecular analysis, immunochemistry, physicochemistry, microbiology, and bioassays, Arcbioassay is adept at conducting a broad spectrum of tests. The company is committed to providing laboratory services that adhere to both national and international standards, backed by its team of capable and knowledgeable experts.
ArcBioAssay Services
Pharmaceutical Quality Control Services by Arcbioassay
Quality Control and Evaluation for Pharmaceutical Products and Raw Materials
IPQC for Biological Pharmaceuticals
In-Process Quality Control (IPQC) of Biological Products
Optimization, Validation, and Quality Control
Comprehensive Drug Control and Evaluation at Research, Development, Pre-Production, and Production Stages
Pharmaceutical Stability Assessment
Development of Stability Protocols and Conducting Stability Studies for Biological Products
Quality Control of Raw Materials
Ensuring Quality and Providing Documentation for Production Line Entry
Comprehensive Drug Technical Document (CTD)
Compilation Based on Food and Drug Administration Standards
Microbial Testing Services
Performing Microbial Tests on Various Pharmaceutical Products
ArcbioAssay Pharmaceutical Quality Control Laboratories
A Team of Skilled and Expert Personnel Equipped with Advanced Technology and Facilities
Physicochemical Laboratory
In our Physicochemical Control Laboratory, we conduct a comprehensive range of physical and chemical quality control tests for biological samples and raw materials. This laboratory is equipped with state-of-the-art instruments including Liquid Chromatography, High-Performance Liquid Chromatography (HPLC), Gas Chromatography, FTIR (Fourier-Transform Infrared Spectroscopy), and more.
Immunochemistry Laboratory
Our Immunochemistry Laboratory offers services such as evaluation of antibodies and recombinant proteins using techniques like ELISA (Enzyme-Linked Immunosorbent Assay), SDS-PAGE (Sodium Dodecyl Sulfate-Polyacrylamide Gel Electrophoresis), Immunoblotting, Affinity Chromatography, and Gel Diffusion Methods.
Molecular Laboratory
In this section, tests related to molecular evaluation of samples are conducted, including PCR-based assays, Real-Time PCR, and Electrophoresis.
Protein Chemistry Laboratory
Our services include protein analysis and identification, concentration determination, examination of pegylated forms, and analysis of compounds such as antibiotics, histamine, trypsin, and host cell proteins in biological samples. These are among the specialized services offered by the Arc Bioassay Protein Chemistry Laboratory.
Cell Culture Laboratory
Another service offered by Arc Bioassay is bioassay activity testing. In the Cell Culture Laboratory, evaluations such as cell viability assays and the biological activity of molecules, particularly antibodies, are performed.
Microbiology Laboratory
Endotoxin testing, various sterility-based tests, colony count assays, antibiograms, and a range of differential and selective tests for bacteria and fungi are conducted in this section.
Laboratory Services for Research and Academic Centers
Providing Analysis Services and Conducting Biological Tests
Arc Bioassay Laboratory Services
While the primary objective of Arc Bioassay, as a partner laboratory of the Food and Drug Administration, is to provide quality control services for pharmaceutical products, the company possesses facilities and equipment capable of significantly aiding the research community in our country. Consequently, from its inception, Arc Bioassay has dedicated a portion of its resources to offering laboratory services to research institutions and esteemed researchers. This commitment has led to Arc Bioassay’s inclusion in the Network of Laboratories for Strategic Technologies.
Available Services:
- HPLC and GC Chromatography Services
- Molecular Genetics and PCR-based Tests
- Protein Services
- Various Microbial Tests
- Cell Viability Assays
- Determination of Biological Material Concentrations in Solutions
- Measurement of Electrical Conductivity in Water and Solutions
- And more…
For Test Request Submission, Please Complete the Following Form
Our Clients
اطلاعات تماس
Central Laboratory: Tehran, Hakim Expressway, Pejouhesh Boulevard, Next to the Genetics Research Institute, Biotechnology Center, Unit 110
Phone Number: 02191097686 – 02191097687
Nazarabad Site: Sepehr Industrial Town, Karestan Boulevard, Bahman West Street, Behnood Farmed Growth Center
Phone: 02645334190 no 117 – 116