By Prabhat Prakash & Prarthana Sharma
Mumbai: Ensuring the safety and efficacy of medicinal commodities is largely dependent on quality control (QC) testing of pharmaceutical and biological products. Regulatory agencies and specialised institutions are essential in maintaining strict standards and fostering collaborations to develop quality control testing methods in India.
Dr Harish Chander, Deputy Director (Quality Control), National Institute of Biologicals (NIB), explained a thorough analysis of the complex environment that surrounds the quality control of pharmaceutical and biological products, highlighting the challenges and efforts of important stakeholders at ETPharma’s Biomolecule Workshop & Connect—Mumbai Chapter.
The absence of international reference standards for Indian producers is a problem that Dr Harish addressed by highlighting NIB’s recent actions, such as the creation of a reference standard unit. With the help of international partners, the unit seeks to create national reference standards that will improve the uniformity and quality of biological products.
NIB’s dedication to maintaining current worldwide standards and best practices in quality control testing is demonstrated by its collaboration with international organisations such as the World Health Organsaiton (WHO) and National Institute for Biological Standards and Control (NIBSC), UK. The institute also extends its services for haemovigilance programme and vaccination testing programmes to Bangladesh, Bhutan, Nepal, other bordering nations and African countries.
The institute’s aim is to train and build capacity, with programmes aimed at regulators, industry experts, and students alike. The objective of NIB is to guarantee the accessibility of superior biological products and improve public health outcomes by encouraging the development of biosimilars and filling gaps in biopharmaceutical innovation.
Dr Chander emphasised that NIB is essential to guaranteeing the efficacy and security of pharmaceutical products. With a broad mandate that includes quality control testing of drug substances and products, the institute places a high emphasis on forming partnerships with domestic and foreign laboratories in order to keep up with developments in quality control testing techniques. NIB is dedicated to offering training facilities for researchers, students, and pharmaceutical industry professionals in addition to its testing obligations. This will help to cultivate a qualified workforce for quality control testing.
Dr Chander highlighted, “The intricate environment surrounding pharmaceutical and biological product quality control (QC) testing, especially in relation to regulatory agencies in India and organisations like WHO, highlights how crucial strict testing procedures guarantee the security and effectiveness of these goods, particularly in light of the complexity and sensitivities that come with biological medications. Healthcare workers’ training programmes, regulatory standards maintenance, and improved QC testing procedures are all part of a concentrated effort to protect patient safety in India, including partnerships with the WHO and other international organisations as well as domestic initiatives.”
The curriculum’s thorough examination of the difficulties surrounding biological medications and how they differ from traditional small-molecule drugs is one of its main highlights. The complex nature of biological molecules is explained to the participants, along with how easily they can be influenced by external factors and how difficult it can be to purify and characterise them. This sophisticated understanding emphasises how important strict quality control procedures are to preserving the integrity of biological products.
Dr Chander emphasised how important these rigorous processes are to maintaining the safety and integrity of biological products. He highlighted the rigorous process used in the licensing of biologicals and biosimilars. This procedure consists of several steps, each of which focuses on important elements to ensure patient safety and effectiveness.
A crucial part of determining the safety and effectiveness of biosimilars is conducting clinical trials. These trials include confirmatory safety and efficacious studies in addition to pharmacokinetic and pharmacodynamic research. When assessing the possibility of immune responses to the biosimilar, safety evaluations must take into account immunogenicity and adverse reaction monitoring. Thorough data gathering and examination throughout clinical trials provide crucial proof in favour of approving these drugs for sale.
The National Control Laboratory (NCL) is essential since it guarantees adherence to recognised procedures like the Indian Pharmacopoeia. This involves a thorough examination of biological products to confirm their efficacy, safety, and quality. Crucially, the NIB functions independently of all parties involved, including producers and oversight organisations such as the Central Drugs Standard Control Organisation (CDSCO). This autonomy promotes confidence in the regulatory structure and guarantees objectivity in testing procedures.
Capillary electrophoresis, enzyme-linked immunosorbent assay (ELISA) tests, ultra-performance liquid chromatography (UPLC), and high-performance liquid chromatography (HPLC) are a few of these methods. By carefully describing pharmaceutical products, these techniques help to guarantee that they fulfil the necessary requirements for potency and purity.
The idea of a quality target product profile (QTPP) is fundamental to the quality control framework. This profile lists the fundamental qualities that a pharmaceutical product needs to have in order to comply with legal requirements and guarantee patient safety. Carefully established parameters, like dosage, administration route, and stability, operate as standards during the production process.
Dr Chander clarified the complex issues surrounding the production, analysis, and regulation of biological products, especially in the Indian setting. The complexity of biological characterisation, where glycosylation variation detection and the description of sub-visible particles emerge as crucial tasks, is central to these problems.
He further explained the variety of analytical methods needed, including the study of sialic acid and monosaccharides, amino acid composition, ligand binding kinetics, and DNA tertiary structure. These methods are essential for guaranteeing the efficacy, safety, and uniformity of biological products.
The lack of international reference standards specifically designed for Indian laboratories and businesses is a conspicuous lack in the landscape. Dr Chander stressed that the industry’s efforts to harmonise and benchmark are hampered by this absence, which is a major obstacle. Considering how urgent this problem is, international cooperation is being used to create national reference standards.
Overcoming these obstacles necessitates a diverse strategy. Dr Chander supports more funding for facilities related to research and development so that Indian labs may perform in-house, thorough biological characterisation. To further ensure regulatory compliance and drive innovation, academic institutions, businesses, and regulatory agencies must work together.
He further added, “In order to ensure that high-quality biologicals are accessible, affordable, and readily available, a nation must establish a strong biotherapeutic ecosystem. Collaboration between academic institutions, regulatory agencies, and the biopharmaceutical sector is important. The creation of facilities with state-of-the-art equipment for pharmacopoeial monograph preparation, reference standards, and analytical training is essential to this endeavour.”
In conclusion, Dr Chander emphasised how crucial it is to preserve uniformity and consistency throughout the whole product development process, especially when testing on specially created cell lines. The testing team usually requests the same cell line that was used in the testing phase when a manufacturer’s product is put through testing. By comparing the manufacturer’s processes to quality standards, this stage guarantees accuracy and transparency in the evaluation process. Should disparities be found, the product might be returned.
