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Biological Products - Biologics

Beyond Pharma

  • Unlike most drugs that contain chemical substances with known structure and purity, biological products are made or derived from biological sources, such as cells, tissues or plasma from humans, animals or microorganisms. Often biological products are complex mixtures that cannot be characterized fully by physico-chemical methods routinely used to characterize most drugs. Biological or therapeutic activity (safety and potency) of biological products is measured by bioassays using biological
  • systems, such as animals, tissues and microorganisms. Therefore, most of the tests for safety and potency have large inherent variability due to biological nature of the product itself as well as variability of biological methods used to test these products. Further, biological products differ from conventional drugs in that these are often heat-sensitive and susceptible to microbial contamination during the manufacturing process and at the final dosage form.
  • This is because the starting materials used in the manufacture of these products are often of biological origin, such as viruses, bacteria and cells that may already have inherent adventitious agents. Additionally, media components used during manufacture and biological products themselves, being proteins, carbohydrates or enzymes, support microbial growth. Therefore, sterile processes are employed from initial manufacturing steps with sterility testing performed at various stages during manufacture.

The BQRC Difference

Achieving Total Quality and Sustainable Compliance for Biologics in a dynamic Regulatory Environment (current Good Manufacturing Practices, cGMP) not only requires expertise in regulations and law governing these products, a thorough knowledge, understanding and practical experience in development and manufacture of these products are essential. The scientific and technical knowledge about these products combined with the regulatory expertise and practical experience ensure total quality and compliance, that exceeding minimum requirements of international regulatory authorities. BQRC offers such expertise (Compliance Through Science with a concept of Good Scientific Practices with Common Sense).
Strategic Planning during Development of Innovative Biological products based on Strong Science using knowledge of regulatory requirements about Critical Quality Attributes, Appropriate Methods for Release Testing and Characterization at various Stages of Manufacture, Quality by Design (QbD) concept, Scientifically Sound Analytical Methods "Suitable for Intended Purpose", Validations, Specifications, etc. will bring such Innovativethese pProducts to the market faster. BQRC provides such service.
Modern Technology based on Proteomics, Genomics, Massive Parallel Sequencing, Modern Microbiological Methods, etc. has not been used often in Testing and Characterization of Biological Products, particularlry legacy products. These methods will not only provide better analytical methods in terms of accuracy and precision, but will help in speed in testing product, ultimately reducing the time taken to manufacture product and help in better understaddning of the product, leading to improving the products in terms of safety and efficacy. BQRC has such expertise.
Understanding Science and Compliance by Staff is critical in achieiving Total Sustainable Quality. People do a great job when they understand the jobit and its impact on the quality of the product. It takes time to mentor, coach and motivate people. BQRC has unique scientific, regulatory, inter-personal and results driven skills to Train Staff in a scientific environment with respect for scientific dissent and independent thinking, but with a focus on results emphasizing the need of decision making to achieve the vision and mission of the organization.