Can you please introduce Bioneeds?

Bioneeds India Private Limited is a leading Indian, Bangalore based, multi segment, multi vertical, preclinical Contract Research Organization (CRO).

We are OECD GLP certified, AAALAC & OLAW accredited, CCSEA registered, and also US-FDA audited, and we extend support to discovery and development programs & testing services for diverse industry segments including pharma, biopharma, medical devices, agrochemicals, industrial chemicals and cosmetics for the last 14+ years.

We have state-of-the-art facilities spread across 300,000 Sft laboratory space, with well-equipped and dedicated labs to support different verticals, 100 experimental animal rooms, “Top-in-line” technologies and a diverse scientific team of 350+ personnel led by highly experienced and acclaimed core team leads.

Our range of service offerings includes GLP studies- acute studies, genotoxicity, inhalation, repeat dose studies-short term & long term, DART studies, teratology and carcinogenicity studies, including formulation and bioanalytical (PK/TK) assessment.

Could you highlight any key milestones the company experienced in 2022?

Enhancing current capabilities, increasing lab space and animal rooms from 85 to 100, dedicated lab areas for inhalation, ecotoxicology, DART and bioassays and adopting new technologies have been few of the highlights to maintain business continuity. Successful US-FDA audits, ISO-17025 (2017) accreditation by NABL, AAALAC re-accreditation and recognition of the animal facility by NIH’s OLAW have been some of the key milestones during 2022, apart from expanding the biopharma services and long-term toxicology projects. Since the pandemic we have worked on several Covid vaccines successfully and currently a few repeat dose intranasal vaccines studies are underway.

What services does Bioneeds offer the biopharmaceutical sector, and how have you seen this space evolve over the past few years?

Infrastructure, technologies, expertise, and tools are in place, and some of the key highlights include preclinical toxicity assessment for biologics, biosimilars, repeat dose toxicity with ADA/NAb assessment, bioanalytical method development, method validation and sample analysis under GLP and GCLP compliant practices and as per US FDA, EMA guidance, PK & PD biomarker assessments. Apart from these we also offer analysis from clinical plasma samples and other sample matrices, flow cytometry, ELISpot based analysis, innate immunogenicity assessment using in-vitro cell models and isolated Human PBMC’s, cell based assays (neutralizing antibody assessment, functional assessment, ADCC/CDC and customization for specific needs), receptor binding assays (using OCTET BLI system), physicochemical characterization using high end systems like LCMS, HPLC etc., biosimilarity assessment including structural, physical, chemical, functional similarity and bioidentity assays, critical reagent generation and qualification and custom PAb/MAb production.

There is an increased investment in the R&D of new drugs and their clinical trials along with increased investments by the government to develop the biopharmaceutical industry, which is offering numerous growth opportunities for the market. The monoclonal antibodies are one of the most-important class of biologics, which account for more than 20% of all the therapeutic candidates authorized by the FDA. Specifically, due to their extensive use in cancer treatment, they are becoming more prevalent in developed countries. In the same way, the demand for anti-inflammatory mAbs is growing at a good pace. The COVID-19 pandemic had a significant impact on the biopharma industry. Most biopharmaceutical companies strive extensively for the development of vaccines and increasing acceptance and huge market demand for biopharmaceuticals and the ability of biopharmaceuticals to treat previously untreatable diseases are driving the current biopharma market.

The above service offering and the strategies adapted by biopharma companies, like outsourcing, has propelled contractual business significantly and had a positive business impact of around 12% of revenue generation. Over the years, with changes in business dynamism from small molecules to large molecules, Bioneeds contract services has gleaned its focus to cater to this opportunity and we foresee a YoY growth of around 15-30% in the coming years.

What do you foresee will be top growth drivers for Bioneeds?

For Bioneeds, the growth drivers continue to be testing services for pharmaceuticals, biopharmaceuticals and medical devices. Capabilities and creating a niche for end-end services for drug discovery and development from bench scale to NDA, and focus on support to generics for ANDA and 505(b)(2) application would impel Bioneeds to have an edge over other competitors.

Furthermore, pricing strategies, quality of service, versatility, customer focus, reproducible and high-quality data generation that is accepted by global regulatory agencies, timely completion of projects, company accreditations and certifications, and reliability of services will drive Bioneeds growth in the coming years.