Analytical Test Methods

Analytical Test Methods in Biopharma

Analytical Test Methods in Biopharma
The biopharmaceutical industry is always evolving due to new and updated regulatory guidelines and novel state of the art technologies for overall efficiency in the marketplace. Manufacturing companies of medicinal products know how important it is to establish compliant and well-organized Quality Control/Quality Assurance laboratories including the use of robust analytical test methods.

Proper methodology ensures the quality, potency, and purity of drug substances and drug products. Clinical and commercial applications including analytical testing are used to determine if drug products are safe to use for human consumption. Our expertise and technical competencies cover a wide range of scientific techniques including, physiochemical, bioassay and microbial testing used for qualitative and quantitative analysis for the identification and quantification of various chemical and biological components in manufactured medicinal products.

BioPharma Consulting Group are experts in determining the most efficient and accurate analytical test methods are used per drug product application across all phases of drug discovery to commercialization ensuring quality, integrity and compliance.

Some Common Methods Include:

• High-Performance Liquid Chromatography (HPLC)
• Capillary Electrophoresis (CE)
• Gas Chromatography (GC)
• Fourier Transform Infrared (FTIR)
• Mass Spectrometry (MS)
• Potency/ELISA Methods

HPLC and CE are used to separate and identify different compounds, while the purpose for using GC is to analyze the volatile organic compounds in drugs. FTIR is used to identify the chemical bonds, and molecular structure while MS is used for molecular weight determination. Potency assays measure biologic activity produced by the required dose to generate a given intensity signal. ELISA methods determine the specificity of antibodies to specific antigens, the assay produces a signal indicating the amount of antigen in a solution. These tests and methodologies combined, identify possible contaminants, impurities, efficacy, chemical bonds and concentration of drug product. The main focus and intent of analytical testing is to recognize and prevent possible health-related issues or side effects that could arise from drug usage and ensuring any risks are detected and mitigated before the medicines are released into the market.

Regulatory Expectations of Analytical Testing
As part of the regulations in the biopharmaceutical industry, analytical test methods are a mandatory requirement across the globe according to the International Council for Harmonisation (ICH) and EudraLex guidelines, pharmacopeias of U.S., Canada, and the European Union. Regulatory authorities set the standards, and biopharmaceutical companies must comply with them. Any failure to comply can have severe consequences, including the denial of drug product approval or marketing of the product in a particular region.

Identifying Possible Impurities and Contaminants
BioPharma Consulting Group’s analytical consultants are essential in ensuring the safety, potency, and purity of drugs in the biopharmaceutical industry. We also aid in identifying possible impurities and contaminants introduced during manufacturing, especially during early phase development prior to commercialization and product release.

BioPharma Consulting Group embraces the latest innovative technologies and use cutting-edge analytical test methods to ensure products have the required level of quality, integrity and compliance. If your company aims to reach the pinnacle of the industry, contact us to discuss how to ensure that your products adhere to all regulatory standards.