Althea Expands Biological Drug Product Manufacturing Operations

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PTSM: Pharmaceutical Technology Sourcing and Management

PTSM: Pharmaceutical Technology Sourcing and Management-01-06-2016, Volume 12, Issue 1

Ajinomoto Althea expands biological drug product manufacturing operations to include ADCs.

Ajinomoto Althea (Althea), a provider of biopharmaceutical contract development and manufacturing services, is expanding its existing biological drug product manufacturing operations to include highly active materials such as antibody drug conjugates (ADCs), according to a Dec. 10, 2015 announcement.

The new facility is located in close proximity to existing Althea operations in San Diego, CA. Process and analytical development laboratories will be available for client programs in January 2016. These laboratories provide clients with services that support their early-stage ADC product development efforts. 

The process development labs are equipped to perform services such as bioconjugation, process development and optimization, ultrafiltration and diafiltration process development, and ADC material generation using low occupation exposure limit (OEL) payloads for pre-clinical studies. The analytical development labs will support process development services such as cleaning verification, raw material identification testing, ADC characterization assays, and safety and potency assays.


In addition to the development labs, Althea's new manufacturing facility will include areas dedicated to bioconjugation, formulation, purification, quality control, and aseptic fill-finish including lyophilization. The facility has been designed for safe handling and manipulation of very low OEL compounds while maintaining aseptic conditions and GMP compliance. 

Source: Ajinomoto Althea