Aragen Life Sciences stands at the forefront of innovation in biologics development and manufacturing, delivering cutting-edge solutions to the global vaccine industry. We spoke to Dr. Satinder Singh, Associate Director of DMPK, who has extensive expertise in immunology, vaccine R&D and advanced vaccine technologies. With more than two decades of R&D experience, Dr. Singh possesses a deep scientific knowledge base and a desire to make better and safer drugs and vaccines. Aragen is expanding the edges on the biologics industry and is contributing towards effective solutions to major global health problems and increasing patient outcomes around the globe.
Let’s delve into the interview details below!
Can you share your professional journey and how you became involved in the vaccine industry? What inspired you to pursue this field?
I began my career at Zydus Research Centre, Ahmedabad in 2004, working in NCE discovery within the molecular pharmacology division. Since graduation, I was drawn to immunology, believing it to be pivotal in addressing unmet medical needs in infectious diseases. Topics like autoimmune diseases and immune system functions piqued my interest and deepened my understanding of how prophylactic vaccines, therapeutic antibodies, and immune cell therapies combat diseases.
In 2008, I joined Cadila Pharma’s Vaccine R&D division, where we developed an allogenic pancreatic cancer vaccine using heat-killed Mycobacterium w (Mw) as an adjuvant. Mw, a potent TLR-2 agonist, induced strong Th1 responses. The vaccine, based on the MIA PaCa-2 cell line, showed robust cell-mediated immune responses against multiple pancreatic cancer cell lines.
This discovery reinforced my desire to positively impact global health by developing therapeutic vaccines for diseases with poor prognosis. There’s a constant need to enhance existing vaccines—making them safer, more effective, affordable, and suitable for distribution in remote regions without cold-chain dependency. Vaccine R&D remains an evolving field with exciting new technologies and approaches.
What were some key milestones in your career that shaped your understanding of vaccine development and innovation?
At Cadila Pharma, I had the privilege of working under the mentorship of Dr. Bakulesh Khamar and Dr. Nirav Desai, where a strong scientific rationale was encouraged. Between 2008 and 2011, I contributed significantly to the development of allogenic anticancer therapy.
Two key milestones stand out:
- While developing an allogenic cancer cell vaccine, we observed that cancer cells incubated with Mycobacterium w (1:100 ratio) altered their immunological profile, overexpressing p38. These cells developed shared immunogens across tissue-specific heterogeneous cancers without cross-reactivity to normal cells or tumors from other organs.
- We recognized that single-antigen vaccines offered limited immunogenicity. Whole-cell vaccines provided a broader spectrum due to multiple immunogenic markers. However, autologous/allogenic therapies pose challenges like batch-to-batch variation, especially across global clinical trial sites. We addressed this by developing and patenting (US9795659B2, EP2537030B1, CN102753975B, CA2789915C) a lyophilized formulation of dead mammalian cells with retained integrity and immunogenicity, reconstitutable at clinical sites and storable at room temperature. This approach was echoed in a 2017 Nature Scientific Reports publication.
Additionally, we isolated stem cells from melanoma and solid tumors and optimized dendritic cell isolation protocols from murine spleen and bone marrow.
The experience at Cadila was marked by a great team, a nurturing environment, and strong support for innovation.
In your opinion, what are the most significant health challenges that vaccines can help address in the coming years?
The effective deployment of economical prophylactic vaccines can significantly reduce the burden of infectious diseases and associated healthcare costs. Vaccines are also expected to play a vital role in combating antimicrobial resistance (AMR) by curbing the excessive use of antibiotics.
Therapeutic vaccines address unmet medical needs in non-infectious diseases such as cancer, hepatitis, and neurodegenerative disorders like Alzheimer’s. Several therapeutic vaccines are in preclinical and clinical development for chronic infections:
- HPV – ADXS11–001, Vvax001, HB-201, ISA101, VGX-3100, GX188E
- HBV – TG1050, Theravax, GS-4774, HeberNasvac, HepTcell vaccine, INO-1800
- HIV – AGS-004, iHIVARNA, MVA.HIVconsv
- HCV – GI-5005, AdCh3NSmut
How does your company ensure transparency and build trust with the public, healthcare professionals, and regulatory bodies?
Aragen is deeply committed to the quality, safety, and effectiveness of its solutions for global clientele. Its core values, “E.T.H.I.C.S.,” shape its culture—with “H” representing “Honesty and Integrity.” By adhering to all applicable laws and demonstrating ethical conduct and responsible business practices, Aragen fosters trust with clients and regulatory bodies.
The company ensures complete transparency by sharing both positive and negative results, delivering reliable and consistent data to accelerate global discovery programs.
Aragen has robust quality systems across all facilities and has been audited and approved by major regulatory agencies, including USFDA, EDQM, ANVISA, PMDA, and WHO. The most recent USFDA audit concluded with no observations.
How important are collaborations and partnerships in accelerating vaccine innovation? Could you share some examples of partnerships that have been significant for your company?
Collaborations fuel cumulative innovation and accelerate vaccine development and manufacturing to cater the global vaccine demand especially during pandemic situation.
Aragen believes in fair and effective collaborations to advance vaccine development through various approaches, including cell line development, lipid nanoparticle technology, and supporting the development of novel vaccine candidates.
Some of the notable partnerships in vaccine development segment includes
- Serum Institute collaborated with Aragen to develop stable cell lines for their HIV vaccine program using their RapTrTM platform, proprietary vectors and CHO DG44 host cells.
- NeoVac partnered with Aragen to manufacture lipid products for lipid nanoparticles (LNPs) used in RNA vaccines.
- Aragen supported Oragenics in the development of their SARS-CoV-2 vaccine candidate, TerraCov2.
These are some of the examples which underscores Aragen’s participation as a key player in the global effort to develop and manufacture vaccines for various diseases.
Vaccine development comes with its challenges, whether scientific, logistical, or regulatory. What hurdles have you personally faced and how did you overcome them?
Navigating the regulatory landscape for autologous and allogenic cell-based vaccines is challenging, requiring specific protocols for cell handling, manufacturing, batch to batch immunogenic response consistency, conformation to specifications and quality control. Ensuring batch to batch consistency w.r.t consistent cell behaviour and immune response across global patient population is difficult. cell characterization manufacturing consistency and demonstrating long-term safety and efficacy are some of the regulatory hurdles that we faced during lyophilized pancreatic cancer vaccine development. The regulatory frameworks cell-based immunotherapies is very complex, requiring careful planning, patient availability and selection and execution of clinical trials.
Looking towards the future, what advice would you offer to others who are aspiring to make an impact in the vaccine industry?
One should begin with a single business vertical—either vaccine R&D or GMP manufacturing—not both at once, as each comes with distinct challenges.
In R&D, the focus should be on discovering novel development and delivery techniques to enhance vaccine effectiveness and patient compliance. From the live, attenuated smallpox vaccine, the field has advanced through live recombinant vaccines, recombinant DNA platforms, nucleic acid-based vaccines, VLP-based vaccines, non-replicating viral vectors, recombinant nanoparticles, peptide vaccines, and now mRNA vaccines. Identifying potent adjuvants that help achieve and sustain adequate titres with a single priming shot can reduce the need for multiple boosters. Developing room temperature stable vaccines will benefit long-term access in developing nations.
In GMP manufacturing, processes must be efficient and streamlined to ensure quick vaccine delivery. Integrated supply chain management helps reduce wastage, minimize delivery time gaps, and improve access for hard-to-reach communities.
Aragen, backed by advanced technologies and state-of-the-art facilities—including single-use bioreactors and cell line development platforms—brings scientific depth and expertise to every stage of biologics development. Aragen offers cell line development, media and feed strategy optimization, resin screening, developability assessment, product characterization, stability studies, formulation screening, non-GMP manufacturing (1 L, 5 L, and 15 L stirred tank bioreactors), and custom approaches to maximize speed and reduce costs.
About Dr. Satinder Singh
Dr. Satinder Singh has over 20 years of experience in Indian pharma and biotech R&D. He began his career in 2004 at Zydus as a Molecular Pharmacologist. From 2008 to 2011, he worked on cellular cancer vaccine immunotherapy at Cadila Pharma, developing a lyophilized whole-cell pancreatic cancer vaccine. Between 2011 and 2014, at Panacea Biotec, he focused on antidiabetic, antidepressant, and anti-infective drug discovery. From 2014 to 2021, at Ipca Labs, he developed generic formulations and explored drug repurposing, including an enhanced bioavailability Atoguanil formulation sourced by MMV for clinical studies. Since 2022, he serves as Associate Director at Aragen Life Sciences, leading DMPK studies.
