AGEN Biomedical offers a service for the
development and manufacture of mammalian cell culture derived Active
Pharmaceutical Ingredients (API) for Phase I/II Clinical Trials as well as
monoclonal antibodies for in vitro diagnostic purposes. Our experience in taking
antibodies from the bench to the clinic makes AGEN your ideal partner for
clinical trial API manufacture or bulk antibody supply. Our TGA licensed
manufacturing suite encompasses two Class C rooms with cold room and cell
storage facilities. Accompanied by in-house analytical and regulatory expertise
as well as established links with drug product manufacturers, AGEN is able to
offer a complete service to assist in taking your product to the clinic.
Mammalian Cell Culture
Serum free/medium adaptation
Media optimisation
Cell line stability assessment
Cell banking
Seed train development
Productivity optimisation
Roller bottles
Small-scale bioreactors
Downstream Processing
Cell harvest/filtration
Purification
Affinity
Hydrophobic interaction
Ion exchange (cation/anion)
Size exclusion
Tangential Flow Ultrafiltration
Viral inactivation/filtration
Viral clearance scale down validation
studies
Spiking study management
Antibody Chemistry
Fragmentation
Digestion
Reduction
Conjugation
Radiochemistry
Other
Formulation and Lyophilisation
Internal expertise and external contractors
Analytical
Electrophoresis (SDS-PAGE, IEF)
HPLC
ELISA (Potency, Immunogenicity)
Radioassays (ITLC, immunoreactivity)
Western blot
Bioburden/endotoxin
Other contractors (peptide map, MS etc)
GMP suite for Drug Substance manufacture (TGA
licensed)
Cell culture
Cell bank storage
Cell expansion (T-flasks)
Roller bottle production (100L batches)
Purification
1-15L columns
Amersham Bioprocess system (120L/hr)
Tangential flow ultrafiltration systems (large
& small scale)
Regulatory Capabilities
Supporting CMC documentation
CTX submission (Australia)
IND submissions (US)
CTA submissions (Canada)
Clinical Assay Capabilities
Pharmacokinetic & Immunogenicity ELISAs
Monoclonal antibody development
Assay design and feasibility
Assay qualification
GLP patient sample storage and analysis
Company Details
• This company produces medical and veterinary diagnostic products based on monoclonal antibody technology. Special fields include human haemostasis and infectious diseases.
Agenix Limited was listed on the Australian Stock Exchange in October... more
