COA
generation & issuance
ICH/cGMP
stability programs
FDA & EMA
approved sample management, analytical laboratories & quality systems
COA
generation & issuance
ICH/cGMP
stability programs
FDA & EMA
approved sample management, analytical laboratories & quality systems
Evaluating the identity, strength, purity, potency, and safety properties of the drug substance and drug product upon release and over the course of its shelf life is critical for regulatory and marketing purposes.
KBI provides a complete range of ICH stability conditions and cGMP test methods to assure the accurate profile of your biopharmaceutical product.KBI excels in the performance of accelerated and long-term stability studies, from developing the protocol to delivering a technical document ready to be placed into your regulatory submission.
KBI’s release and stability program experience includes products in all stages of development, from preclinical to commercial, and covers the full spectrum of biopharmaceutical products, such as antibodies, enzymes, fusion proteins, PEGlyated proteins, conjugates, protein vaccines, peptides, and olionucleotides.KBI excels in the performance of accelerated and long-term stability studies, from developing the protocol to delivering.
Our services include:
Peptide mapping
Western blot
ELISA
HPLC (SEC, RP, IEX, HIC, etc.)
UV (A280)
BCA, Bradford, etc.
ELISA
HPLC (RP)
HPLC (SEC, RP, IEX, HIC, etc.)
SDS-PAGE, IEF
CE (CE-SDS, cIEF, CZE)
Enzymatic activity
Cell based assay (proliferation, cytokine release, etc.)
Ligand-binding (ELISA, Biacore, Forte Bio)
Residual host cell protein via ELISA
Other process residuals (e.g., antibiotics, inducers, detergents, etc.)
Bioburden
Residual DNA via qPCR
Endotoxin
Appearance (USP/EP)
Osmolality
Residual moisture
Subvisible particles via HIAC and MFI, including evaluation of particles <10µm
Glycan profile via NP-HPLC, CZE, etc.
pH
Are you looking to accelerate your program or just want to learn more about our services?
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