IPOPBA-
STOCK.ADOBE.COM
4 Pharmaceutical Technology
®
|
BioPharm International
®
Bio/Pharma Outsourcing Innovation February 2025 PharmTech.com
N
ext-generation biotherapeutics pose challenges
to the development of manufacturing processes
and analytical characterization because of their
complexity and, in some cases, novelty. From
cell and gene therapies (CGTs) and new vaccines to an-
tibody-drug conjugates (ADCs), successful development
and commercialization of these next-generation therapies
may hinge on partnerships with service providers that
offer specific focus, expertise, and technological experi-
ence. At certain points in the discovery and development
process, developers—especially smaller firms—come
to realize the unmet needs that prompt them to seek an
outsourcing provider and/or partnership. The first order
of business would be to bring in a partner with the correct
expertise and technology to tackle the challenges of bring-
ing a complex biotherapeutic to market.
Challenges
Bringing next-generation therapies to market brings
up multiple challenges, according to Monika Paule,
CEO, Caszyme. These challenges range from scientific
and technical hurdles to regulatory and societal barri-
ers. "One of the major obstacles is the social perception
and acceptance of novel technologies such as CRISPR
[clustered regularly interspaced short palindromic
repeats]. Addressing public concerns, providing ac-
curate information, and engaging in meaningful di-
alogue about the benefits, risks, and ethical consider-
ations of these technologies are crucial," Paule says.
Ali Pashazadeh, CEO, Treehill Partners, a transac-
tion and drug development advisor y firm focused
on the biotech industr y, points to the fact that the
biopharmaceutical industry is currently experienc-
Outsourcing Next-Gen
Therapies Relies on
Expertise and Technology
Feliza Mirasol
The value of outsourcing partnerships for next-gen biotherapeutics rests
in the expertise and technologies that service providers bring to the table.
