R&D capabilities

R&D capabilities

90+ scientists and researchers in India and Germany

R&D capabilities

50+ year stronghold

in developing and commercializing complex products

R&D capabilities

Strong IP

15+ product patents across the globe

Patents filed

In India
  • Cited: 5
  • Filed: 3
  • Granted: 2
  • In force: 17
Patents filed in
  • Brazil Brazil
  • China China
  • Saudi Arabia Saudi Arabia
  • South Korea South Korea
  • India India
Patents granted in
  • Australia Australia
  • Eurasia Eurasia
  • Canada Canada
  • Europe Europe
  • South Africa South Africa
  • India India

Biotechnology R & D

Research remains the strongest pillar in our journey towards providing high-quality and affordable medication. BSV is one of the earliest manufacturers of gonadotropin biosimilars (fertility hormones such as FSH, LH, HCG) in India.

The process for biosimilar medicine development involves a stringent development procedure, starting with the structure and functional aspects of the reference medical product, through advanced analytical technologies. Once the desired quality attribute profile is established, our scientists are involved in quality clone selection from thousands of cells. The optimal clone that produces the therapeutic protein of interest, matches the biological function of the reference product as closely as possible, thereby demonstrating that there are no clinically meaningful differences between the reference product and the biosimilar based on the findings from all of these studies.

We were the first Indian company to introduce the biosimilar version of the recombinant FSH in 2008. Keeping up with the advances in the medical field, we’ve introduced various strengths and sophisticated presentations, like multidose pen injections. BSV has also launched the recombinant biosimilar of chorionic gonadotropin in India & ROW markets.

We have expanded the gonadotropin biosimilar portfolio along with monoclonal antibodies. With our team of experts, BSV introduced a novel Biologic monoclonal antibody in 2021. This product is used to prevent Rh isoimmunization in pregnant women.

R&D Biotech Capabilities:

Cell culture: Cell culture process development activities at BSV cover the full product development cycle, starting from supporting early-stage clone evaluation efforts through small-scale protein production to comprehensive process development programs. BSV has extensive experience in developing monoclonal antibodies, heavily glycosylated gonadotropin hormones and other recombinant therapeutic proteins.

Downstream purification capabilities: BSV employs a highly evolved downstream mAb platform designed to provide robust impurity clearance including adventitious agents and also has proficiency in expedited process development for non-mAbs like complex therapeutic gonadotropin hormones and other recombinant proteins.

Analytical development: BSV employs a phase-specific lifecycle approach to analytics. Our analytical capabilities include Protein Primary Structure analysis, Biophysical Characterization, Glycan Analysis, HPLC/UPLC (SEC, RP, Affinity, IEX, HIC etc), Capillary electrophoresis (CZE, CIEF etc.) and Process residuals (ELISA, qPCR etc), potency assays & Mass spectrometry (intact mass, disulfide mapping, Peptide mapping with LC/MS or LC/MS/MS, Post-translational modifications (e.g., oxidation, deamidation), Glycan Identification & site identification etc.

Drug product Development: The drug product development team is engaged in cutting-edge technologies to develop both liquid and lyophilised presentations for various routes of administration for patients. BSV extensively collaborates with various partners to develop new medical devices to aid pain management for patients.

  • Gonadotropin hormones play a pivotal role in the regulation of follicular development and ovulation process. Inadequate levels of gonadotropin, follicle-stimulating hormone (FSH), can result in the absence of ovulation. Ovulatory dysfunction, which is common among women of reproductive age, often results in infertility. Thus, FSH stimulation plays a critical role in follicular recruitment and dominant follicle selection. FSH triggers the growth of eggs within the ovaries and prepares the eggs for ovulation.
  • BSV, as the brand leader in the r-hFSH market, has introduced a recombinant Folitropin Alpha Pen that supports ergonomic comfort to the patient and doctor, while handling and injection, making sure that the set dose is accurately delivered for effective outcomes.
  • The pen is shipped in a box with the TransTracker H which ensures that the cold chain is being maintained during shipment, till the usage point. The label adds an additional layer of security, clearly indicating whether the drug is fit for usage.
  • The major advantage of our FSH Pen is that it is supplied with very fine disposable needles of 31G 8 mm dimensions which ensures very minimalistic pain at the site of injection. Our brand is available in multiple strengths of 300, 450, 900 & 1200 IU.
  • Manages and treats Rh-negative pregnancies. It is used in the prevention of Rh isoimmunization of Rh-negative women with Rh-positive pregnancies. It is indicated to prevent Rh-negative women from forming antibodies to the fetal rhesus-positive red blood cells that may pass into the maternal blood during childbirth, abortion, or certain other sensitizing events.
  • As a leading supplier of Trinbelimab (recombinant Anti Rh(o) D Immunogloblin) for postpartum prophylaxis, BSV has significantly prevented hemolytic disease in newborns (HDN) by providing a reliable supply of Trinbelimab (recombinant Anti Rh(o) D Immunogloblin) products in India for over 35 years.
  • BSV developed a Trinbelimab (recombinant Anti Rh(o) D Immunoglobulin) from hybridoma-based technology and has been approved for use in India since 2010. We further developed the recombinant version of Anti-D Immunoglobulin (Trinbelimab) expressed in the Chinese Hamster Ovary (CHO) cell line.

The recombinant version of human chorionic gonadotropin hormone is used in ART, in conjunction with FSH to trigger final follicular maturation and luteinisation after stimulation of follicular growth. It is available at a strength of 6500 IU in a prefilled syringe.

Equine Biologicals

For over 2 decades, Equine Biologicals has been a critical part of the BSV research vertical, pioneering various products, in this field, in India; the first of several of the Equine products in Anti Snake Venom Serum, Anti Rabies Antiserum. Adding to this impressive portfolio, we are also the sole manufacturer of Anti Thymocyte Globulin in the country.

The team, which is a crucial link between research and commercial production, is made up of scientists from various biological disciplines, with extensive knowledge in the purification of biological products, delivering positive patient outcomes.

Equine Capabilities:

Our strengths reside largely around the purification of antigens and the design of immunization procedures for efficient antibody development. The team’s capabilities are in:

  • Purification & characterization of antigens for immunization
  • Cryopreservation
  • Designing Mixtures and Immunisation Regimens for maximum antibody titre development
  • Purification of immunoglobulins from crude plasma with high specific activity
  • Standardisation and validation of analytical methods and alternates to the use of animals
  • Development of Cell-based assays
  • Development of stable, high-yielding, virus-inactivated, highly purified manufacturing processes.
  • Development of stable formulations for delivery as liquid and lyophilized preparations.
  • Preclinical development studies
  • Clinical Studies

Equine Products:

Active Projects

  • Anti-Snake Venom Serum
  • Anti Rabies Serum
  • Anti-Thymocyte Globulin

Past Projects

  • Anti Tetanus serums
  • Anti Diphtheria serum
  • Anti Covid-19 Antiserum
  • African Snake Venom Anti Serum

New Drug Delivery Systems

From conceptualization to commercialization, the New Drug Delivery Systems (NDDS) team is dedicated to pioneering advancements across a spectrum of drug delivery platforms. Our expertise spans a wide array of systems, including liposomes, colloidal suspensions, lipid complexes, emulsions, microspheres, implants, and solid oral formulations.

At NDDS we push the boundaries of drug delivery technology, developing novel solutions that optimize the efficacy, safety, and patient-friendliness of pharmaceutical products. Our breakthrough technologies have revolutionized the delivery of numerous molecules, setting new standards for therapeutic efficacy.

Our focus on knowledge-based and non-infringing patentable technologies drives our efforts in developing complex generic and speciality pharmaceutical products. Our R&D development pipeline includes critical molecules with solubility and stability challenges as well as difficult to formulate and characterize polypeptides. Our extensive portfolio includes formulations like lyophilized products, colloidal suspensions, microemulsions, pegylated & non-pegylated liposomes, micelles, lipid complexes, topical gels, solid and liquid oral formulations, ophthalmic microemulsion, biodegradable polymer-based depot injections and implants.

NDDS Products:

  • Leuprolide Acetate
  • Dinoprostone Gel
  • Goserelin Acetate Implant
  • Carboprost Tromethamine
  • Cetrorelix Acetate
  • Micronised Progesterone
  • Dydrogesterone
  • Amphotericin B
  • Polymyxin B
  • Colistimethate Sodium
  • Doxorubicin Hydrochloride Non-Pegylated Liposomal
  • Doxorubicin Hydrochloride Pegylated Liposomal
  • Enoxaparin Sodium
  • Ferric carboxymaltose

At the heart of our formulation development lies a robust analytical infrastructure, meticulously designed to support innovation and precision. Equipped with state-of-the-art instrumentation, including our facilities ensure thorough characterization and optimization of formulations. A cohort of seasoned scientists spearheads injectable product development with unparalleled proficiency.

A network of complementary functional areas stands ready to offer support at every stage- from Project Management to Quality Assurance, Regulatory Operations & Affairs, Pre-clinical and Clinical expertise, to Commercial Supply Operations, our comprehensive infrastructure ensures seamless execution. Fusing diverse expertise and disciplines, our multidisciplinary teams navigate the intricate landscape of regulatory compliance and manufacturability, ensuring that our formulations meet rigorous standards across lab, pilot, and commercial scales.

Future Product Pipelines

With growing consumerization globally, the patient is playing a bigger role in the healthcare ecosystem. Every stakeholder needs to evaluate each step of drug development, delivery, and relationship management, keeping the patient at the centre of it.

We are currently developing a wide range of products in the fertility, critical care, bite management and infectious diseases portfolios.

We aim to enhance BSV’s niche portfolio in the IVF segment, including complex analogues of naturally occurring hormones with improved efficacy and a combination of products aiding in the ART (assisted reproductive technologies) procedures.

We are constantly improving existing products, and exploring new-age delivery systems.

Animal Testing

We house a world-class Animal Testing Facility (the Facility) and Quality Control Laboratory at our  Ambernath manufacturing plant (Maharashtra). In line with requirements from World Health Organisation (WHO), Pharmacopeia (Indian, United States, British & European), OECD GLP, Central Drug Standards Control Organization (CDSCO) and State Food & Drug Authority (FDA), the Facility is under the care of a team of highly qualified doctorates, veterinarians, biotechnologists, and biologists. This Facility has an Institutional Animal Ethics Committee (IAEC) appointed by the CPCSEA, Govt. of India which oversees and approves all animal experiment protocols. Post approvals, animals are bred, and experiments are conducted as per scientific and ethical norms, and requirements of national laws. BSV has agreements with government-approved vendors for the safe disposal of biomedical and other waste generated in the Facility, as per existing standard environmental laws.

“BSV’s Animal Testing Facility demonstrates our commitment towards augmenting scientific research, as we strive to establish the safety and efficacy of new medicines before they reach patients.   Going ahead, we would like to transform this Facility into a Centre of Excellence and are working towards being OECD GLP certified, with complete adherence to good laboratory practices that ensure accurate, safe, high-quality, and consistent results that will deliver improved patient outcomes,” said Sanjiv Navangul, MD & CEO, BSV.

“We remain focused on delivering quality products and safer treatments to our patients.  We ensure that the research undertaken in the Facility is predicated on consideration for animal welfare and sound scientific reasoning while adhering to all relevant and governing laws.  The specially trained scientific and technical staff undergo routine health checks and are fully trained on fire safety, emergency evacuation, first aid and other similar international requirements,” said Dr Sanjeeb Kumar Mishra, President – Quality, BSV.