4 BioPharm International eBook April 2019 www.biopharminternational.com
Outsourcing Resources Chemistry, Manufacturing, and Controls
CMC Due Diligence for Accelerated
Biologic Drug Development
and Manufacturing
The growing trend of partnerships between small biotech companies
and CDMOs makes the need for conducting CMC due diligence
increasingly important.
T
he biopha r maceut ica l business model is
undergoing a rapid transformation with the
discover y and implementation of disr up -
tive new platform technologies for accel-
erated dr ug discover y, development, and
manufacturing for new drug modalities to address
unmet medical needs. As the need for accelerated
biopharmaceutical development around the world
continues to grow, clinical-stage therapeutic compa-
nies are facing complex challenges that need to be
overcome and must remain competitive for increas-
ing process productivity, reducing cost, mitigating
risks, and bringing safe and efficacious products
to market faster. To achieve this goal, more and
yoshitaka/Stock.Adobe.com
YANHUAI (RICHARD) DING*, PHD, is director, Downstream Process
Development and Manufacturing, rding@Anaptysbio.com; MARGARET (PEGGY)
MARINO, PHD, is vice-president, Program Management; ALEX PRASEUTH,
PHD, is associate director, Drug Product Development; JOE SHEFFER, M.SC,
is CMC program manager; KEVIN ZEN, PHD, is executive director, Analytical
Development; and HEMANT KUMAR, PHD, is senior vice-president, head of
Process Development and Manufacturing; all at AnaptysBio.
*To whom correspondence should be addressed.
YANHUAI (RICHARD) DING, PEGGY MARINO, ALEX PRASEUTH, JOE SHEFFER, KEVIN ZEN, AND HEMANT KUMAR
