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: