Expert Consultancy for Biotech Solutions

At VaxBioSolutions, we specialize in guiding biotech companies through the complex CMC landscape. From concept to market, our expertise ensures that your research and development projects thrive.

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CMC Consulting

Expert guidance through the entire CMC process, ensuring compliance and efficiency.

Research Development Support

Assistance in navigating the challenges of research and development in the biotech sector.

Market Readiness Assessment

Evaluating and preparing your products for a successful market entry.

Who We Are

Highly qualified and motivated professionals

Expert in Vaccine research & Biologicals, Bioprocessing, Gene therapy and CMC Leadership:
Dr Gaurav Gupta is a seasoned biotech professional with over 20 years of experience in vaccine research, development, and commercialization. Specializing in Chemistry, Manufacturing, and Controls (CMC) leadership, He has expertise across a broad spectrum of vaccine modalities, including live attenuated, inactivated, subunit protein/VLPs, viral-vectored, and mRNA vaccines. He has delivered several biotherapeutics projects from early stage to late stage CMC.

Key Achievements:

Successfully led the production of 50+ vaccine candidates for clinical trials, with 11 receiving market authorization.
Directed CMC and manufacturing teams for cutting-edge projects, including COVID-19 vaccines, malaria vaccines, and HPV therapeutics.
Expertly managed cross-functional teams of scientists, technicians, and external collaborators in India, the UK, Europe, and the US.
Delivered several global client projects on vaccines and biologicals

Professional Journey:

Granza Bio (Oxford, UK): Current Head of Research, focusing on novel cancer therapeutics, lab installations, team and project management.
Loma Therapeutics (Copenhagen, Denmark): Current CMC manager for therapeutics HPV cancer vaccine.
Speransa Therapeutics (Germany): Head of CMC and Manufacturing, delivering ORF viral-vectored COVID-19 vaccine candidates and managing CDMO collaborations.
Vaccine Manufacturing and Innovation Centre (VMIC, UK): CMC Lead for process and analytical development of diverse vaccine platforms.
Jenner Institute, University of Oxford (UK): Senior Research Scientist, driving GMP process development and supporting ChAdOx1 nCoV-19 development.
Vaxbio Ltd.: Co-founder and Director, launching early-stage COVID-19 vaccine platforms.
Zydus Cadila Healthcare (India): Deputy Chief Scientific Officer, leading virology and biotech initiatives for multiple vaccine projects.
Panacea Biotec (India): Senior Scientific Officer, spearheading viral vaccine development and technology transfer.
Biomed Pvt. Ltd. (India): Microbiologist, optimizing processes for poultry viral vaccines and developing new vaccine formulations.

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Team members

QC, QA expert

Seasoned QA/QC professional with over 22 years in the biopharma industry, specializing in biosimilars, cell & gene therapy, and vaccines.
Experienced with global regulatory inspections (US-FDA, MHRA, EMA, etc.) and a trained internal/external auditor.
Strong in failure investigations, CAPA implementation, and proficient in eQMS tools like Trackwise, Simploud, and LIMS.
Expert in developing compliant Quality Management Systems aligned with ISO, USFDA, ICH, and EU standards.

Finance and administration lead:

Mrs. Shivani Gupta

Experienced in accounting, finance and administration roles with more than 15 years

Team members

CMC Expert- Bioprocess Scale up and Technology transfer

Over two decades of leadership in the biotechnology sector, specializing in mAbs, Vaccines (Human, recombinant, glycoconjugate, animal, poultry), Infectious Diseases, next generation platforms- AAV, Lentiviral and biotherapeutics
Extensive experience across the entire product lifecycle from discovery to market launch, with a focus on accelerating product readiness during pandemics.
Led multiple technology transfers, clinical and commercial operations, CMC submissions and CDMO site operations
Oversaw full-spectrum CMC activities—from development through manufacturing (USP/DSP/Formulation) in alignment with US FDA,EU and WHO regulatory requirements
End-to-end site operations, establishing infrastructure and capabilities (Greenfield and Brownfield projects for high-containment (BSL-2+) R&D, process development, cGMP manufacturing
Pioneered the adoption of new technologies to improve operational excellence across biologics, CGT, mAbs, and vaccines.

Team Members

Preclinical Research Expert

Preclinical Research Expert

Passionate researcher and science manager with over 25 years of R&D experience focused on infectious and non-communicable diseases.
Experienced in translating innovative research from bench to bedside, demonstrating strong problem-solving and leadership skills.
Led cross-functional teams to execute strategic research initiatives and groundbreaking projects.
Secured over 10 collaborative projects funded by the European Commission, national governments, and private investors.
Acted as the primary liaison between research consortia, stakeholders, customers, and funding agencies to fostering collaboration and managing complex research partnerships.
Inventor of 3 international patents and author of multiple scientific publications.

Team members

Project Manager

Over 20 years of experience in Regulatory Affairs and Labeling, including 11 years in global drug labeling.
As a lead consultant worked with Sanofi and Johnson & Johnson, managing regulatory labeling and artwork reviews.
Skilled in handling complex Health Authority queries and ensuring compliance with international regulatory standards.
Expertise includes medical device documentation, CE marking, 510(k) submissions, and pharmacovigilance support.
Proficient in regulatory systems like Veeva Vault, CONNECT, and COCOON, delivering efficient, compliant solutions globally.