4 Pharmaceutical Technology
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Bio/Pharma Outsourcing Innovation eBook February 2024 PharmTech.com
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I
n the dynamic landscape of pharmaceutical de-
velopment, the management of modern sterile
product developments has become an increasingly
complex task, attributed to the evolving diversity of
APIs. The landscape now encompasses a wide range
of pharmaceutical entities, ranging from traditional
small molecules to the forefront of biotechnological
advancements including biologics (e.g., proteins, fu-
sion proteins, bispecific antibodies, antibody-drug
conjugates peptides, and nucleic acid-based therapeu-
tics including oligonucleotides, RNA and DNA thera-
peutics, viral vectors, cell therapy, and more). Most of
these later APIs are formulated as parenteral prepara-
tions, amplifying the unique multifaceted challenges
associated in terms of formulation, manufacturing,
administration, and regulatory considerations.
Adding to the complexity, there is a noticeable shift in
administration routes from the traditional intravenous
(IV) to alternatives like subcutaneous (SC) because of
patient convenience considerations, or other special-
ized routes, such as intravitreal (IVT) administration.
This transformative shift in administration routes not
only demands innovative approaches to formulation
and product presentation, but also necessitates a com-
prehensive understanding of the distinct challenges
posed by each route and each product configuration.
As these trends reshape the pharmaceutical land-
scape, managing the intricacies of sterile product
development becomes imperative for successful and
compliant outcomes requiring the combination and
application of scientific and industry expertise, tech-
nological advancements, and regulatory acumen.
Managing the Complexity
of Modern Sterile
Product Developments
Andrea Allmendinger
is chief science officer, and
Hanns-Christian Mahler is
chief executive officer, both
at ten23 health, Mattenstr.
22, 4058 Basel, Switzerland.
Managing the intricacies of sterile product development
is imperative for successful and compliant outcomes.
