By Pratibha Raju and Abhijeet Singh

New Delhi: Synthetic Peptides and Oligonucleotides is a rapidly growing segment in biomolecule industry, Experts participating in ET Pharma’s Biomolecule Workshop and Connect Mumbai Chapter 2024 said that scientific advancements and active market participation have led to some significant changes in a short period of time and a complete transformation at an unprecedented pace.

Organized by ETPharma to bring together several industry experts and other stakeholders to exchange their views, share their valuable experiences, discuss key challenges, new trends and future outlook of the biomolecule drugs market, especially synthetic peptides and oligonucleotides. Gathered in the second chapter.

Workshop partner partners were Cytiva, exhibition partner DAICEL; Ami Polymer; Shree Sanghvi & Company and Thermo Fisher Scientific.

The workshop served as a platform to discuss and learn about recent developments, changing trends, regulatory issues and strategies to overcome them. Its objective was to bring together industry leaders and leading scientists working in the field to share their experiences and help other participants learn about this specific topic. Experts discussed the major challenges and future prospects of the biomolecule industry.

The main focus areas of the event were biopharmaceuticals; Biotechnology; Healthcare and pharmaceutical services and life sciences research.

The conference began with opening remarks followed by a guest address by the Chief Guest, Dr. Harish Chander Deputy Director (QC), National Institute of Biologicals on ‘Discovering Critical Quality Attributes (CQAs) in Complex Biopharmaceuticals’.

In his address, Dr. Chander explained the difference between minor drugs and biologics, and emphasized the need and importance of Critical Quality Attributes (CQAs) for patient safety. While providing the information he also talked about the Quality Target Product Profile (QTTP) considered by various regulatory agencies

Following the guest address, there will be a keynote session on Cracking the Code of Complex Pharmaceuticals: Discovery of Critical Quality Attributes in Peptides and Oligonucleotides (CQA and PQA), which will be delivered by Dr. Manoj Pananchukunath, Chief Scientific Officer, Biocon Limited.

In the keynote session, Dr. Pananchukunath raised concerns over the absence of specifications and methodology in the industry, which prevents companies from testing their product under varying conditions and variations, leading to rejection of their approval applications, while He also noted the company’s reluctance to rigorously test its drugs.

The keynote session was followed by a session on Oligonucleotides Therapeutics: A Complete Oligo Workflow for Process Development and Beyond, by Asees Singh, Nucleic Acid Therapy, Workflow Expert, India, Cytiva.

Speaking at the event, Asees Singh dissected the oligonucleotide development process which includes synthesis; cracking and preservation; purification; desalination and concentration; He also shared some valuable insights of operational technologies and gave some tips to the industry players for full scale manufacturing.

The next topic of discussion immediately after the Oligonucleotides Therapeutics session was on the current challenges and regulatory insights in immunogenicity assessment of peptide products by Dr. Ravi Shankar, Senior General Manager R&D, Sun Pharma.

The session was based on one of the key discussion points of the workshop, in the 40 minute long session, Dr. Ravi emphasized on the importance of product characterization, profiling and bioassay for early detection of problems and overcoming last minute challenges . In his presentation, Dr. Ravi elaborated on impurity profiling by outlining the steps in which impurities can evolve during the synthesis process. Throwing light on the regulatory process, Dr. Ravi simplified the nuances of the rules and highlighted the mistakes made by companies while applying for approval.

After the session on current challenges and regulatory insights in the assessment of immunogenicity of peptide products, the workshop had a session on Ensuring purity and safety: Innovations in biomolecule impurity characterization, by Prof. Dr. Hosahudya N Gopi, Professor of Chemistry, IISER, Pune. By.

Using the platform, Dr. Gopi described synthesis, open storage, pH conditions and temperature as some of the major factors that contribute to the production of impurities in peptide drugs. He further provided detailed descriptions on how racemization occurs during various synthesis processes, along with suggested methods. Keep control over them.

Session on Ensuring Purity and Safety: Innovation in Biomolecule Impurity Characterization Dr. Ravi Shah, Assistant Professor, National Institute of Pharmaceutical Education and Research (NIPER) conducted a session on Quality Assessment of Oligonucleotides: Challenges and Opportunities.

Addressing the curious audience, Dr. Ravi shared several important quality attributes used for quality assessment of oligonucleotides. The professor stressed the importance of QbDs (Quality by Design) and a discriminative risk assessment methodology to support and correlate the chosen analytical methodology. He provided guidance in employing the impurity strategy and suggested several analytical solutions for ANDA-comparative evaluation with the RLD (reference listed drug).

The workshop had a session on case studies: mRNA vaccine From concept to clinic by Dr. Ajay Singh, Head-mRNA, Gennova, Biopharmaceuticals.

Dr. Ajay presented a case study on India’s first indigenously developed mRNA vaccine: GEMCOVAC-19 and GEMCOVAC-OM (Omicron Specific Booster Vaccine) both approved by DCGI (Drugs Controller General of India). In his presentation the doctor provided a comprehensive overview of every aspect of the process from discussions to final approval. “The developed vaccine has the potential to neutralize most of the emerging Covid variants,” he said.

The case study session was followed by a session on zooming inside the HOS of in-formulation state biopharmaceuticals. NMR spectroscopy By Professor, Ashutosh Kumar, Department of Structural Biology, Bioscience and Bioengineering, Indian Institute of Technology (IIT), Bombay.

In the half-hour long session, the academician explained in detail the working of NMR (Nuclear Magnetic Resonance) technology with special focus on NMR spectroscopy. He explained how the technology helps analyze the complex structure of biomolecules, adding that it can pinpoint changes by isolating signals in specific regions. NMR is also effective in dealing with pH variations and characterizes insulin in its prepared phase thereby providing effective results.

The technical session was followed by a panel discussion on Harmonizing Progress: Catalyzing Biomolecule Advancement through Tri-Sector Collaboration (Academia, Regulatory Bodies and Industry).

Panelists for the session were Dr. Tathagata Dutta, President and Chief Technology Officer, Jodas Expoim Pvt. Ltd.; Rohit Jadhav, General Manager, Analytical Research & Development, Kashiv Biosciences LLC; Dr. Muralidharan Chandrakesan, Vice President, Aurobindo Pharma; and Dr. Rajesh Bahker, Senior General Manager, Medicinal Chemistry, New Drug Discovery, Zydus Cadilaand Dr. Manoj Meta, Principal Scientist – Global Biologics, US Pharmacopoeia. The panel was moderated by Professor Ashutosh Kumar, Department of Structural Biology, Bioscience and Bioengineering, Indian Institute of Technology (IIT) Bombay.

Initiating the discussion, Moderator Professor Ashutosh Kumar endorsed the idea of a harmonious alliance between academia, industry and regulator to make valuable contribution in realizing the ambitious goal of self-reliant India by 2047.

Professor Kumar said that in the coming days, bio-based economy is going to be worth 500 billion dollars, in which biopharma industry has a major role. Highlighting the phenomenal growth of the biomolecule industry, Dr Chandrakesan, one of the panelists, said, “The molecule industry is booming and in terms of production we are moving from kilograms to tonnes.” He further mentioned the dependence on China for sourcing amino acids. This is one of the key areas that the industry and agencies should focus on in the coming days.

Contributing to the discussion, another panelist, Dr. Tathagata Dutta, expressed concern over the outdated parameters and urged the authorities to explore and incorporate several modern methods, which are impacting both manufacturers and patients. He described the gap adding, “There are approximately 23 nucleotide and oligonucleotide drugs approved by the USFDA and available across the world, but Indian patients are deprived of this benefit due to them not being approved by the domestic regulatory body.

Exploring the role and responsibilities of academia, Dr. Rajesh urged the educational institutions to promote innovative thinking among their students and provide infrastructure and grants so that they can focus on the concept which can later be developed through industry collaboration. Can be increased through.

Dr. Rajesh clearly urged the Government of India to develop its own specific guidelines instead of following the guidelines issued by the USFDA, he also advocated the inclusion of more industry individuals in the regulatory panel.

Participating in the discussion, Dr. Metta cited several initiatives taken by pharmacopoeias across the world to harmonize product quality through uniform standards.

Answering a question from the moderator related to the shelf life of synthetic peptides, Rohit Jadhav called for a strong academic-industry partnership for thorough product characterization and impurity profiling, further he explored each corner of the peptide as a drug product. Advised to define and focus. On the aggregation part at the time of product development.