ByoEdu 2019 is a conference organised with a goal to strengthen 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’s need

    • Today, In India there is a gap between the industry expectations and the skill produced by the current education system. To bridge this gap this unique interactive conference will address following requirements.
    • The 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 career
    • 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
  • The regulatory requirements for product approval

Activities

1. ByoEdu2019 will contribute towards improved academic-industrial collaborations by bringing together academic researchers and industrial leaders on the right platform.

2. Subsequent to one-day conference, twelve monthly webinars and webcasts allowing participants to sharpen the edge on technical topics presented by industry and academia practitioners to maintain the momentum throughout the year.

3. ByoEdu2019 will be held on November 30, 2019 in Mumbai and will have keynote speeches and panel discussions with networking opportunities.

Topics

Recombinant DNA technology was just an imagination till 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 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. A ground breaking research is also happening in other fields such as agriculture with the help of recombinant technology. Methods of recombinant DNA technology, gene therapy, and genetic modifications are also widely used for the purpose of bioremediation and treating serious diseases.

Specifically, in 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 a 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 anemia. Continuous efforts are being put to utilize this method for manufacturing new drugs targeted to new challenging diseases.

The drugs of biological origins have attracted the attention of many pharmaceutical companies where it is essential to protect the heterogeneous nature and the optimal three-dimensional structures of the different macromolecules. These molecules are used in both the investigation and therapy purposes, so their maximum activities should be maintained. This requires the designing of certain delivery formulations that suits the macromolecule nature, its target organ, the required dose and delivery route, and that’s why the biotech companies invest millions of dollars towards achieving that. The second focal point concentrates on the current considerations for optimizing their delivery for a maximum performance in the body.

The Formulation technologies and delivery routes of the different biopharmaceuticals for different diseases can’t be studied separately. The chemical and physical properties of the drug, its biological activity, excipient types, and the administration routes should be essentially investigated as background information towards the designing of an efficient drug formulation. This is important for maintaining the maximum activity of the drug for performing its function in its target tissue.

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.

Physicochemical Properties:

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 three broad categories, there are many quality attributes that are covered under these which requires 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, there are some other techniques which are also required for understanding the physicochemical properties.

Functional/Biological characterization:

Bioassays address the need to demonstrate mechanism of action of protein therapeutic. This is very 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. Development of functional or potency assays is one of the most challenging aspects of the biotherapeutic development. Some well-known assays include antigen-binding assays, cell-binding assays, Proliferation assay, CDC & ADCC.

Mass spectrometry:

Mass spectrometry has emerged as the most important analytical technique for characterization of biotherapeutic molecules for various reasons. It helps in determining the primary and higher order structure. Mass spectrometry helps determine and confirm the primary structure of biosimilars as part of analytical comparability activities. Certain mass spectrometry techniques can be used to define and characterize post-translational modifications (PTMs). Characterization includes identity and structural analysis of the modification as well as location and occupancy of PTM(s) within the primary structure of the respective biosimilar molecules.

Total fifty-seven biosimilars have been launched in India till date. This impressive achievement by industry has demonstrated scientific talent and operational capabilities of Indian scientific workforce. To further strengthen this position and succeed in the next stage of entering in other world markets, industry needs:

  1. Trained and skilled employees
  2. CRO’s & CMO’s with expertise in innovative technologies
  3. Enabling academic institutes to gain innovation and technical capabilities through association with industry.
  4. Co-op program for students to get industry-experience during bachelors and master’s program
  5. Development of eco system of collaboration between industry R&D and university research institutes

Speakers

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