12 BioPharm International eBook April 2019 www.biopharminternational.com
Outsourcing Resources Quality Control
Using the Multiple Attribute Method for
Process Development and Quality Control
More manufacturers are embracing MAM, which simplifies
biopharmaceutical product quality testing, and facilitates the
measurement and monitoring of critical quality attributes.
C
omplex biopha r maceut ica ls, such as
monoclonal antibodies, can be extremely
sensitive, and subject to alterations due to
post-translational modifications (PTM)
and degradation of the product during
storage. Conventionally, a large battery of tests is
required to detect impurities, but each method can
only detect a limited set of problems. Several years
ago, a team at Amgen began to work on a method that
would simplify quality control (QC) by reducing the
number of tests required, and that would allow devel-
opers to assess critical-to-quality product attributes
throughout development.
Since initial work with Thermo Fisher, Amgen is
now using this method, called multiple attribute
method (MAM), in QC and process development.
Biopharmaceutical manufacturers of all sizes, and a
growing number of contract development and manu-
facturing organizations (CDMOs) are also evaluating
or working with the method. Analytical equipment,
software, and reagent vendors are also offering prod-
ucts tailored for use with MAM.
Richard Rogers, who worked on the Amgen team
that pioneered MAM and is now principal scientist at
Just Biotherapeutics, discussed MAM and its history
with BioPharm International.
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AGNES SHANLEY
