Services

Highly Potent Active Pharmaceutical Ingredient (HPAPI)

Highly Potent API (HPAPI) requires specialized equipment in addition to expertise in the handling of potent substances. Between two sites located in Campoverde, Italy and Sligo, Ireland. AbbVie CMO has the capability of producing your HPAPI with containment capabilities up to OEB5 (<0.1 µg/m3). These sites have more than 20 years of experience and can support a broad range of commercial GMP batch sizes including from gram scale up to 600kg. Additionally, both sites are setup with oral solid dosage (OSD) manufacturing capabilities as well and can be your end-to-end supplier.

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Potent substance to drug product all in one location:

Our sites with potent handling capabilities also have commercial drug product manufacturing that allows for a smooth flow of manufacturing from a single location. This can help simplify your supply chain, remove transportation and customs headaches, and shorten supply chain lead times.

High Potency Capabilities

OEB5 (OEL band category 3b, <0.1 µg/m3) facility with containment from isolator charging to encapsulation
OEB4 (OEL band category 3a, <1 µg/m3) facility with two suites containing S3 glove box for powder charging/discharging
OEB3 (OEL band category 2b, <10 µg/m3) higher volume facility with S2 glove bag for powder charging/discharging and filter dryer potent containment

HPAPI Manufacturing Scales

Reactors capable of OEB 3 from 4,000 L to 12,000 L
Reactors capable OEB 4 up from 5,000 L to 6,300 L
Reactors capable OEB 5 from 50 L to 3,200 L

HPAPI Downstream Process Capabilities

Filter Dryers
Centrifuges
Small scale chromatography

HPAPI Product Development and Manufacturing

Small scale processing up to 5 L
High pressure hydrogenation and carbonylation
Linker-payloads for antibody-drug conjugates
On-site analytical testing

HPAPI QC Testing Capabilities

Residual solvents
UPLC, HPLC
GC, GC-HS, GC-MC
Heavy Metals
On site microbiological laboratory

End-to-End High Potent Manufacturing

OSD up to OEB 5 in Sligo MHR, Ireland
OSD up to OEB 3 in Campoverde, Italy
Aseptic Vials up to OEB 5 in Sligo BT, Ireland

An AbbVie CMO representative is eager to talk to you.

AbbVie CMO is a seasoned partner for all your contract manufacturing needs. Let’s start a conversation today. The future is a click away.

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