ByoEdu 2019 is a conference organised with a goal to strengthen the current biopharmaceutical ecosystem in India. This conference focuses on the skill empowerment of the current generation of young industry employees and academicians wishing to join this industry
Today, In India there is a gap between the industry expectations and the skill produced by the current education system. This unique interactive conference will address the following requirements and help fill up this gap:
- Most important considerations of the industry: Quality, Technology and Regulatory.
- Setting up of co-op programs for bachelors, masters and PhD students early in their educational careers is needed.
- Need of cross-functional team approach towards research:
1. Pathologist and analytical scientist for biomarker discovery.
2. Process development engineers and regulatory affairs for IPR generation and innovative product development.
- Regulatory requirements for product approval.
- ByoEdu2019 will contribute towards improved academic-industrial collaborations by bringing together academic researchers and industrial leaders on the right platform.
- Subsequent to the one-day conference, twelve-monthly webinars and webcasts will allow the participants to sharpen the edge on technical topics presented by industry and will help academia practitioners to maintain the momentum throughout the year.
- ByoEdu2019 will be held on November 30, 2019, in Mumbai and will have keynote speeches and panel discussions with networking opportunities.
Recombinant DNA technology was just an imagination until the twentieth century. It was thought that desirable characteristics can be incorporated into the living organisms by making genetic changes and controlling the expression of target genes. However, this imagination actually came into existence only in the twenty-first century and has demonstrated a unique impact in bringing advancement in human life. By virtue of this technology, crucial proteins required for health problems and dietary purposes can be produced safely, affordably, and sufficiently. Continuous efforts are being put to utilize this method for manufacturing new drugs targeted to new challenging diseases. Methods of recombinant DNA technology, gene therapy, and genetic modifications are also widely used for the purpose of bioremediation and in the agriculture sector.
Specifically, in the Biopharmaceutical sector, recombinant technology has been used very effectively for the production of some hotshot molecules. For example, Lispro (Humalog), in comparison with regular human insulin, is an effective and fast-acting recombinant insulin. Similarly, Epoetin alfa is a novel and well-recognized recombinant protein that can be effectively used in curing of anaemia.
Bioprocessing is the process that uses living cells and/or their components for industrial production of a desired product. Development of a product using bioprocess technology involves multiple processes starting from clone development to yield optimization and product purification processes. Bioprocessing is a part of several industries and technologies involving production of biofuels, bio-therapeutics, nutraceutical product, enzymes and metabolites.
Its wide range of applications allows need for customized process strategy designing, method development and abidance to guidelines lead by regulatory bodies. This can be achieved by contribution of people from interdisciplinary domains having experience in both life science and engineering.
However, designing a suitable protocol for bioprocessing requires thorough skill and knowledge about multiple attributes at every stage. The customization of specific process can be a challenging task. Developing a product of consistent and good quality is challenging as it requires highly controlled operational parameters. Thus, to achieve this operational challenges needs to be focused.
The development of a biosimilar is a highly multifaceted and manifested process using cell lines similar to that of the innovator as well as identical (clones) to each other. However, improper and unskilled handling of cell lines may result in making an inconsistent and insufficient product. Besides, small variations made in choice of an organism, vector or biomarker, feed strategy, cell line stability or cell line generation can affect the antibody-dependent cell cytotoxicity (ADCC), half-life, stability and immunogenicity of the biosimilar product. Thus, the development of appropriate manufacturing cell line having sufficient yield and quality in minimum time is critical.
Various approaches are developed to ensure that the cell line development process produces a biosimilar that meets the required criteria. For example: Increase in cell density, viability and productivity using animal‐component‐free hydrolysates can be done. A high‐throughput cell culture scale‐down systems combined with statistical design of experiment (DOE) can be used in cell line development to shorten development time. Product quality attributes (PQA) assessment which assess product`s integrity, activity, aggregation, glycan profile and quality control testing is also considered.
Today seven out of ten top pharmaceutical blockbusters are biologics due to their specific mechanism of action. This character of biologic is attributed to its physicochemical and functional properties. Therefore, development of biosimilar, which are follow-on version of biologics, involves comprehensive physicochemical and biological characterization followed by nonclinical and clinical studies.
Today, most Important sector of Biopharma industry in India is biosimilars development which requires comprehensive demonstration of biosimilarity based on the similarity between the physicochemical properties of the innovator and the biosimilar product. The physicochemical characterization can be broadly categorized into:
- Primary and higher-order structure characterization,
- General charge heterogeneity and amino acid modifications,
- Glycosylation and size heterogeneity.
Although there are three broad categories, there are many quality attributes that are covered under these which requires a variety of analytical methods and techniques for the comprehensive characterization of a biotherapeutic. Some of the well-known analytical techniques are HPLC (RP, SEC, CEX), DLS, AUC, CD, FTIR, DSC and LC-MS. Additionally, some other techniques are also required for understanding the physicochemical properties.
Development of functional or potency assays is one of the most challenging aspects of biotherapeutic development. Bioassays address the need to demonstrate the mechanism of action of protein therapeutic and is an extremely essential part of protein characterization and demonstration of biosimilarity. Over the last decade, bioassays have become more important in effectively demonstrating the quality, efficacy and safety of biopharmaceuticals. Some well-known assays include antigen-binding assays, cell-binding assays, Proliferation assay, CDC & ADCC.
Mass spectrometry has emerged as the most important analytical technique for characterization of biotherapeutic molecules. It helps in determining the primary and higher-order structure and to confirm the primary structure of biosimilars as part of analytical comparability activities. Mass spectrometry techniques can be used to define and characterize post-translational modifications (PTMs) for identification and structural analysis of the modification as well as location and occupancy of PTM(s) within the primary structure of the respective biosimilar molecules.
Biosimilars are products of biological origin that are highly similar to already existing original biological product (originator biologic/ innovator) pertaining to quality, biological activities, safety and efficacy as that of innovator. They are passed through numerous critical quality attributes including clinical and non- clinical studies in comparison with innovator to ensure their equivalence with respect to safety and efficacy before their approval in the market.
The preclinical studies usually involve meticulous analytical characterization; assessments of structure, function and immunogenicity of the biosimilar and studies of their mechanism of action (MOA), in vivo pharmacokinetics (PK) and pharmacodynamics (PD) in animals. Along with this, clinical development is done which focuses mainly on confirming and resolving the uncertainties with respect to purity, potency, safety and efficacy of biosimilar product in comparison to innovator.
Once the product has passed through such thorough pre-clinical and clinical assessment, they are ready for commercialization. For the successful commercialization, multiple factors such as availability of sufficient funding for product development and manufacturing; efficiency of scaling and processing methods; ability of the product to meet the regulatory requirements; current market status etc. should be considered.