Biologics Quality & Regulatory Consultants, LLC (BQRC) was founded in 2013 by Chander Gupta and Rajesh Gupta with more than 50 years combined experience in development, manufacture, and regulation of biological products, mainly vaccines and blood-derived products.
Biologics Quality & Regulatory Consultants, LLC (BQRC) was founded in 2013 by Chander Gupta and Rajesh Gupta with more than 50 years combined experience in development, manufacture, and regulation of biological products, mainly vaccines and blood-derived products. Knowledge and understanding in development, manufacture, and regulation of biological products was gained through working at the National Regulatory Agency (NRA) in the US (Center for Biologics Evaluation and Research, CBER, Food and Drug Administration, FDA), National Control Laboratory (NCL) in India (Biological Standardization and Quality Control Division, Central Drug Laboratory, at the Central Research Institute, Kasauli) and the US (Division of Biological Standards and Quality Control, CBER, FDA), premium research organizations (National Institutes of Health in the US and National Institute of Immunology in India), leading manufacturers of vaccines and blood-derived products (Central Research Institute in India, Massachusetts Biologics Laboratory, Wyeth, and Chiron in the US), and a consulting organization for biologics (Biologics Consulting Group).
During working at the FDA from 2006 to 2013 and gaining insights in the approval process of biological products, Rajesh observed that several life-saving innovative biologics do not become available to the needy patients at the earliest due to missing or deficient information in biological license applications (BLA), leading to several information requests (IR) and even complete response (CR) letters causing delays in reviews and ultimately delays in approval and availability of these life-saving products. There are very few products that get approved in the required timeframe (6-months for accelerated reviews and 10-months for regular reviews)due to these deficiencies and information presented in a manner that is not clear or as required or expected by the regulatory agencies.
The major goal of forming BQRC was to serve the public health by having life-saving innovative products available to the patients at the earliest by advising companies/academia on strategies and documentation on development of product, manufacturing process, and validations, that are expected or required by the regulatory agencies, so that the regulatory reviews on BLAs are fast and smooth with minimal information requests and no CR issues.
Achieving Total Quality and Sustainable Compliancefor 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, 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 and knowledge about process and product, including Critical Quality Attributes, Critical Process Parameters and Critical Starting Materials and knowledge and understanding about regulations and Regulatory Guidance, including appropriate and Scientifically Sound Analytical Methods “Suitable for Intended Purpose”, Characterization and testing at various Stages of Manufacture, Quality by Design (QbD) concept, Validations, Specifications, etc. will bring the products faster to the market by smooth regulatory approvals. 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, particularly 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 understanding 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 achieving Total Sustainable Quality. People do a great job when they understand the job 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.
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 media components used during manufacture of these products, 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. Additionally, 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 and extraneous or adventitious microbial contaminants. Thus, extensive testing is essential throughout manufacture of biological products.