Biologics R&D facility for small scale drug substances
Jigani, Karnataka, India
Designated research and development facility
When it comes to developing breakthrough biologics, our Jigani facility can take your drug substance and drug product candidates from concept to reality, with laser-focused process optimization, scale-up and analytical methods. With global regulatory approvals and rigorous quality standards, we accelerate biologics development without compromise.
Process development capabilities for biologics development
- Cell-culture/fermentation process optimization
- Detailed analytical and bioassay development and validation
- Risk assessment using the Failure, Method and Effect Analysis (FEMA) tool to Critical Process Parameters (CPPs) / Key Process Parameters (KPPs)
- Process characterisation to develop operating and design space for the CPPs and KPPs for manufacturing support
Scale-up lab facility
- Capability to convert drug substances to stable formulations and fill-finish formats
- For mammalian upstream and downstream process scale-up studies: 50L
- For microbial upstream and downstream process scale-up studies: 5L and 20L
- Flexibility in operations – single-use or multi-use depending on process requirements
Analytical method development and qualification
- RP, NP, HILIC, IEX and SEC methods
- Impurities, purity, content estimation
- Impurity clearance methods
- Characterization methods
- Transfer, verification and qualification
In-process analytics
- From early to late phase of bioprocess monitoring, SDS page, HPLC/UPLC – UV/PDA/Fluorescence/CAD/ELSD
- Process monitoring and developing controls
- Process-related impurities analysis
- Product-related impurities analysis
- Oxidation / deamidation / truncation products
- Aggregation analysis
Structural characterization and confirmation
- Amino acid sequence
- Amino acid composition
- Terminal amino acid sequence (MS/MS sequencing)
- Peptide map
- Disulphide bridges
- Carbohydrate structure
Product characterization
- Glycan profiling
- Structural characterization
- Thermal analysis intact mass analysis
- Peptide mass fingerprinting
- Sequence confirmation
- Disulfide bond and sulfhydryl group confirmation
- Identification of post-translational modifications (PTMs)
Quality control
Our Jigani facility excels at every aspect of quality control. We execute rigorous stability studies on drug substances and products, following strict ICH guidelines. Our comprehensive animal efficacy and toxicology studies and advanced identity and potency characterization studies deliver exactly what you need for dossier submissions, leaving no stone unturned. And our in-process validation ensures every step of the production process meets our uncompromising quality standards.
Facility approvals:
USFDA
EUGMP
MHRA
WHO
Address
#293, Jigani Link Road Bommasandra,
Anekul Taluk, Bangalore,
Karnataka, India 560105.