Analytical characterization and quality control

Syngene provides services to characterize proteins by various high end techniques for impurity identification and characterization, higher order structural characterization and biological assays by cell-based, binding or other types of assays, including in-vivo assays. We can provide custom packages for protein characterization to support your IND and biosimilar applications.

All quality control testing, starting with raw material testing, in-process testing to finished product testing, environmental and water quality monitoring, microbiological testing, and product lot release and stability testing is carried out in-house in compliance with global GMP standards.
Analytical and Quality Control Services include

Analytical method transfer or development followed by qualification
Analytical method validation (ICH Q2R1)

Bioassays

Potency determination by in vitro cell based assays, non-cell based assays (ligand binding assay) and in vivo assays, including bioassay validation as per pharmacopeial guidelines

Advanced analytics capabilities for complex biological molecules

Syngene’s centre for advanced protein studies (CAPS) helps your complex biological molecules move closer to regulatory approval by providing advanced analytical services for the assessment of physicochemical characteristics, efficacy, immunogenicity, contamination, and strength.
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Biochemical Analysis

Protein quantitation
Immunological assays
HPLC and UPLC-based assays for related substances and charged variants
Process residuals such as Protein A or other additives
Aggregate analysis by SEC and DLS
Process related impurities such as host cell protein and host cell DNA
Electrophoresis including capillary electrophoresis and imaged capillary electrophoresis
Glycoform analysis including monosaccharide composition, glycan structure, glycosylation site determination by peptide maps, LC-MS/MS and NP-HPLC
Peptide mass fingerprinting and amino acid sequencing
Impurity characterization

Biosimilar Development and Characterization

Syngene is highly proficient in developing biosimilar processes as well as conducting biosimilarity assessment and biosimilar characterization. Members of our team have helped launch several biosimilar products in regulated and semi-regulated markets. We have conducted extensive biosimilarity characterization for products made by clients from the US as well as India, and have excellent systems developed to conduct product characterization and method validation.

Cell line development
Drug substance and drug product process development
Basic biosimilar characterization package
Advanced biosimilar characterization package

Infrastructure

Syngene’s biologics lab is a state-of-the-art facility with a plant for GMP production of biotherapeutics to be used in clinical studies along with process development and analytical labs.

GMP Plant

We have independent suites for microbial and mammalian cell derived products; completely segregated upstream and downstream operations, HVAC and personnel. The facility is designed for optimal personnel and product flow. We have pre- and post-viral removal steps in separate rooms for mammalian DSP. Our production facility includes microbial – 200L, 500L fermentor and mammalian – multiple of 100L, 500L and 2000L disposable bioreactors. The facility has automated control of process steps, cleaning and CIP through Delta-V system.

Process Development

We have independent upstream and downstream labs for microbial, hybridoma and mammalian based products, and a range of equipment to carry out small-scale screening studies as well as process confirmation or tech transfer runs prior to scale up.

Formulation Development

Spray drier
Pilot lyophilizer
Vial filling from 0.5mL to 20 ml/ vial

Analytical & Quality Control

HPLC with multiple wavelength (MWD), photo diode array (PDA), fluorescence (FD), charged aerosol (CAD), evaporative laser scanning (ELSD) and refractive index (RI) detectors
UPLC with PDA
MALDI-TOF/ TOF
LC-ESI-MS/MS
GC-MS
Biacore
Flow cytometer
PA 800plus (capillary gel electrophoresis)
Imaged capillary electrophoresis
Slab gel electrophoresis (SDS-PAGE, blotting, agarose)
Gel documentation system with calibrated densitometer
ELISA reader with absorbance, luminescence, fluorescence readers with micro plate well washer
Solo VPE
Flowcam
Maurice (cIEF)
HIAC
Subvisible particle counter (PAMAS)
Karl Fischer coulometric titrator
Total organic carbon analyzer

Stability Chambers

Stability chambers from -70°C to + 40°C with humidity control
Photostability chamber
Stability chambers under access control and full GMP operation