Biologics & Biosimilars

In the recent past, the healthcare landscape has witnessed a massive shift towards biopharmaceutical, with biologics and biosimilars representing a major class of modern therapeutics. Many innovator products and biosimilars have been introduced to offer a promising cure to a wide variety of disease conditions; however, there is still a huge gap to address the unmet needs in multiple therapeutic areas. Though biosimilars offer a significant cost advantage over biologics, the manufacturers face many challenges in their development.

We at VIMTA provide various analytical services for your biopharma products. With an experience of close to a decade in supporting biologics and biosimilars programs including recombinant proteins and peptides, monoclonal antibodies, and nucleic acid-based drugs; we are an ideal partner for all bioanalytical and characterization services. Our bioanalytical and characterization packages are tailored to meet your distinct biosimilar development needs, and we use latest technologies and procedures to ensure accuracy of data and adherence to regulations and guidelines. We possess the requisite technical and scientific expertise to develop novel assays for addressing your discovery requirements and regulatory queries.

Our cGMP compliant laboratory is equipped with state-of-the-art technologies as LCMS (Liquid Chromatography Mass Spectrometry), HPLC, ABI sequencing platform, q-PCR, MALDI-TOF, Bioplex 200, multimode plate reader, etc.; and offers robust testing solutions to support both novel biologics and biosimilars during their development cycle – from discovery to preclinical, clinical and marketed product release. We offer cGMP compliant phase appropriate method validation and transfer, relevant early-stage characterization, and later stage comparative data generation in accordance with the regulatory requirements.

Our service offerings include:

  • Potency testing
  • Immunogenicity studies and cytokine profiling
  • Antibody titer and serology study for vaccines
  • Bioidentity and monograph studies
  • Biowaiver studies for complex generics
  • Mass spec analysis of peptides and proteins
  • Impurity profiling and excipient analysis
  • Post translational modifications and bioanalytical studies
  • Comparative assessment for biosimilars and ANDA

Apart from these, we also offer testing services for toxicology, stability, and extractables and leachables, and are equipped to handle complete clinical trial needs.

Our team consists of highly qualified people with technical expertise and strong research acumen. Being fully conversant with regulations, we have the capabilities to work for any regulatory market, and offer certainty to deliver even the critical projects within the timelines. Our experience enables our customers to navigate the challenges of biosimilar development, confirmation of biosimilarity, comparative safety and efficacy studies and also market release. We have successfully been offering end to end services to a range of biologics and biosimilars, while helping others in different stages of development, and our data has been accepted by USFDA & European regulators.