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Let’s Make ADC

Services and Capabilities

As your premier service provider, Althea’s ADC service offerings will simplify your supply chain by consolidating high containment conjugation, formulation, fill finish and release and stability testing at the same facility.

Conjugation and PurificationProcess verification
Preparation of GLP tox material
cGMP conjugation for clinical and commercial applications
Isolator for potent compound handling
Reactor sizes 10L-100L (single use system)
Single Use TFF unit with membrane capacity up to 2m2
Single use chromatography system
Facility will be designed and tested to handle compounds with OEL down to 1 ng/m3
Fill & Finish and Lyophilization CapabilitiescGMP clinical and commercial fill finish
120 Vials/Min for 2 mL vials
Fill line batch sizes up to 70,000 vials
Lyophilizer batch capacity up to 20,000
Vial sizes - 2 mL – 20 mL
Isolator technology
External vial washer
Process DevelopmentConjugation process development milligram to gram scale
UF/DF development
Chromatography methods development
Formulation development
Material generation for pre-clinical studies including analytical characterization
Analytical CapabilitiesMALS/IR
LC/MS/HPLC, UHPLC
CE, icIEF
UV/VIS
SDS-PAGE
ELISA / LBA
Moisture, CCI
Environmental /bioburden testing
LAL

Althea staff will provide you with technical expertise, robust quality systems and experienced personnel to support interactions with regulatory bodies worldwide at all stages of your drug development process.

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