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Biopharmaceutical product development

Gnanika TechBio develops any biopharmaceutical products from a vial to a finished product within a short span of just 4 months.

Biologics and Biosimilar development (R&D)

Gnanika TechBio provides product development and manufacturing services (R&D scale-up) for companies that require a one-stop solution for mammalian cell-culture based protein therapeutics – monoclonal antibody, bi-specific antibodies, fusion proteins, peptides, hormones, enzymes, etc. The team is experienced to undertake end-to-end activities right from cell line development to clinical manufacturing. We can develop safe and cost-effective biopharmaceuticals with various biological formulations.

Process Development

Gnanika TechBio provides extensive mammalian cell culture-based products development services. The labs have the capability of performing complete process development, process optimization, scale-up, technology transfers, and process characterisation. Moreover, our scientists have demonstrated the capability to design and execute development work to meet defined product quality attributes.

Formulation Development

Gnanika TechBio offers formulation development services for biopharmaceutical products based on target formulation profiles. We carried out collaboratively with analytical development groups to ensure that robust and stability-indicating analytical methods are used appropriately during formulation development. We deliver the best formulation for your product by carrying real-time stability and varieties of stress stability studies.

Biologics development (R&D)

  • Molecular Cloning of target gene
  • Protein Expression
  • MCB/WCB vial preparation
  • Upstream: the cell biomass production (flask to bioreactor)
  • Downstream: Protein purification (mg to gram)
  • Technology transfer (R&D) to the clients
  • Preclinical study: RCGM-CDSCO approval (discussion with clients)
  • Clinical study: RCGM-CDSCO approval (discussion with clients)

Biosimilar product development (R&D)

  • Molecular Cloning of target gene
  • Protein Expression
  • MCB/WCB vial preparation
  • Upstream: the cell biomass production (flask to bioreactor)
  • Downstream: Protein purification (mg to gram)
  • Technology transfer (R&D) to the clients
  • Preclinical study: RCGM-CDSCO approval (discussion with clients)
  • Clinical study: RCGM-CDSCO approval (discussion with clients)

Technology transfer to the Clients

  • Product development (Cloning, recombinant protein expression, and purification)
  • Pre-clinical approved products (up to animal study)
  • Clinically approved products (up to Phase I to Phase 4 study in Humans)

Microbiology Services – Finished products and Raw material analysis

• Total Bacterial Count (TBC)
• Total Aerobic Microbial Count (TAMC)
• Anaerobic Plate Count (APC)
• Sterility test (Membrane Filtration method)
• Coliform test (Membrane Filtration method)
• Enumeration of coliforms (MPN)
• Enumeration of Yeast and mould
• Bacterial endotoxin test (LAL method)
• Growth promotion test (GPT)
• Bioburden testing
• Disinfectant efficacy test
• Swab analysis (Cleaning validation)
• Pathogens isolation and identification
• Microbiology Documentation (SOP, STP, and IOP preparation)

Molecular Biology Services – Molecular Cloning and Protein expression

• Cloning and Sub-cloning genes
• Protein expression
• Master Cell Bank (MCB) preparation
• Working Cell Bank (WCB) preparation
• Gene expression studies by PCR, RT-PCR, and qPCR methods
• Blotting techniques: Southern, Northern, and Western blot hybridization
• Mutants construction by Site-directed mutagenesis / Marker-exchange mutagenesis
• Gene knockout
• Molecular Biology Documentation (SOP, STP, and IOP preparation)

Upstream Processing Services

• Mammalian Cell line Biomass production
• Microbial Cell Biomass production
• Yeast Cell Biomass production
• Scale up the Biomass from flask to Bioreactor
• Kinetic study: Cell growth, pH, temperature, DO, nutrient, and agitation
• Cell Biomass production as per regulatory (RCGM)

Downstream processing Services

  • Purification of recombinant proteins (Biologics & Biosimilar) from the Cell Biomass
    • Affinity chromatography (NI-NTA resin)
    • Anion Exchange chromatography (DEAE Sepharose, Crypto Q resin)
    • Cation Exchange chromatography (Crypto S resin)
    • Size Exclusion chromatography (Sephadex resin)
  • Fast protein liquid chromatography (FPLC)
  • High-performance Liquid Chromatography (HPLC)
  • Tangential flow filtration (TFF)
  • Biologics and Biosimilar Purification as per regulatory

Documentation Services

  • Helping for application submission to Regulatory
  • Supporting QC document preparation
  • Supporting QA document preparation
  • Supporting IOP document preparation
  • Supporting BMR document preparation

With access to

GNANIKA TECHBIO

PVT LTD

Assistance

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