Debayan Ghosh

Founder & CMD

The biopharmaceutical industry is focusing on developing safe, effective, and affordable biologics. Unlike chemical drugs, biologics are highly targeted, such as clot-specific thrombolytics and antibody therapies in oncology, which minimize unwanted effects. In vaccines, antigen proteins or genetic material mimic pathogens without using actual viruses, enhancing immune responses, especially when combined with nanoparticle scaffolds. To ensure affordability, biotech scientists are advancing new platforms for higher-yield production of therapeutic proteins and optimizing bioprocesses to lower manufacturing costs. These innovations aim to make life-saving treatments accessible to more patients worldwide without compromising on safety or efficacy. However, patients often face challenges such as high costs of biologics, limited access to advanced therapies, and lengthy development timelines. Additionally, navigating complex regulatory environments and ensuring product consistency and quality across large-scale production add further difficulties. Epygen Biotech is at the forefront of biologics innovation, specializing in the development of high-quality, affordable biologics, biosimilars, and vaccines. Leveraging advanced protein expression technologies and rapid development platforms, the company addresses critical health challenges with a commitment to excellence and accessibility in global healthcare solutions.

Leading Innovation in Biopharmaceuticals and Manufacturing

Since its inception, Epygen Biopharmaceuticals has been at the forefront of innovation in biologics, with a strong focus on recombinant protein expression and separation technologies. The company's journey began with the development of a safer, more affordable version of recombinant Streptokinase, a vital drug for treating myocardial infarction. By replacing the traditional Beta- Lactam marker with a non-Beta-Lactam alternative, the firm provided a cost-effective solution for patients who couldn't afford costly tissue plasminogen activator injections. This breakthrough set the foundation for Epygen's commitment to delivering accessible, high-quality therapeutics and addressing critical healthcare needs. Its state-of-the-art injectable vial lines, with an annual filling capacity of 24 million vials, reflect the company's focus on scaling production without compromising on quality. Regular audits and comprehensive documentation further reinforce the company's commitment to excellence. “Through these efforts, Epygen has not only positioned itself as a leader in biologics but also as a company driven by a mission to make high-quality therapeutics accessible to all”, says Debayan Ghosh, Founder & CMD.

Transforming Healthcare with Cutting-Edge Biologics and Vaccines

Epygen Biotech specializes in developing biosimilars for chronic metabolic conditions such as diabetes and bone diseases, making essential therapies more accessible to patients. In response to the COVID-19 pandemic, the firm innovated by collaborating with a U.S. firm to create a platform that produces protein-based vaccine antigens within 100 days of identifying a virus variant, demonstrating its commitment to rapid pandemic preparedness and effective infectious disease control. In the oncology field, the company employs advanced gene manipulation techniques to enhance protein yields and streamline post-translational modifications, ensuring that complex treatments are both affordable and effective. Additionally, Epygen offers a comprehensive end-to-end manufacturing service, managing every stage from clone development to vialing.

The company's expertise extends across various host platforms, including bacterial, fungal, and yeast systems, enabling it to tackle each of its unique challenges. The firm's team excels in developing clones, maximizing protein expression, and optimizing downstream processes for high purity and cost-effectiveness. The company's in-process quality control (IPQC) and quality control (QC) teams meticulously monitor every production stage to ensure compliance with the highest regulatory standards. By integrating cutting-edge technology with precise process management, Epygen delivers reliable, high-quality biologics, maintaining both efficacy and affordability for clients throughout the biopharmaceutical industry.

Epygen Biotech distinguishes itself in the industry through its exceptional focus on innovation, regulatory compliance, and quality assurance. The company navigates the complex regulatory landscape by adhering to stringent national and international standards, including oversight from the Review Committee of Genetic Manipulation (RCGM), the Central Drugs Standard Control Organization (CDSCO), the FDA, and WHO. This rigorous approach ensures that every biologic drug development and manufacturing aspect meets the highest quality benchmarks. Epygen excels in scaling up sensitive proteins through advanced bioprocess optimization, media design, and downstream processing (DSP) techniques. The team expertly addresses challenges like solubilization, refolding, and resin binding, ensuring consistent protein quality. The company utilizes advanced automation and systematic process controls to maintain batch consistency. Rigorous testing of hundreds of in-process Drug Substance (DS), and Drug Product (DP) samples, both online and offline, is integral to their quality assurance. Epygen’s stringent quality plans adhere to the highest regulatory standards, ensuring sterility and integrity at every production stage. This rigorous approach guarantees that Epygen delivers biologics with exceptional quality and safety.

Over the next five years, Epygen aims to strengthen its CDMO vertical by partnering with clients to develop biosimilars for critical ailments like diabetes and bone diseases. In vaccine development, the company plans to leverage its expertise in protein expression platforms to create advanced protein and nanoparticle-based vaccines within 100 days, enhancing pandemic preparedness. Additionally, the injectable division will expand vial and cartridge filling lines to support in-house innovations and meet the needs of key biologics clients with top-tier quality standards.