Outsourcing single-use technologies to accelerate speed to market To fast-track time to market and gain a competitive edge, pharmaceutical development companies are increasingly implementing single-use technologies (SUT).
filling. SUTs offer many benefits compared to
development, one area of emphasis to speed time
traditional stainless steel systems, such as the
to market is outsourcing the design, development,
elimination of clean-in-place or steam-in-place
production and validation of the SUT assemblies
(CIP/SIP) requirements, faster changeovers
and systems.
between batches resulting in reduced production
S
time, more flexible infrastructure and a decreased
Invest upfront and focus on the science
risk of cross-contamination.
By outsourcing, companies can keep the scientists
Although standard, off-the-shelf SUT
and engineers focused solely on new product
assemblies are currently available, most are
development. As product development progresses,
narrowly focused on upstream processes using
scientists should not be spending their time
ingle-use technologies are built
kit components like bottles, tubing, connectors
designing and putting together bottles, caps and
using an array of components, including sampling
and filters likely supporting research applications.
tubing systems, but instead maintain focus on the
bottles, tubing, filters, clamps, check valves,
There are, however, a few companies leading the
product. Unfortunately, off-the-shelf components
sterile connectors, Luer locks and fittings, seals
innovation of single-use systems for fill/finish. In
may not meet this requirement; single-use systems
and gaskets, and dispensing tips/nozzles. The
addition, novel biologics and synthetic compounds
comprising various components can quickly
technology can be as simple as a single assembly
often have unique manufacturing processes that
become a complex system that requires expertise
or an entire system made up of multiple complex
require custom assemblies that are more advanced
in choice of materials, biocompatibility, connection
assemblies that are utilised across the entire
than standard off-the-shelf options.
strength and integrity.
manufacturing process, including formulation,
Given the increasing adoption of single-use
“Research into the development of single-use
upstream/downstream processing and final product
technology for both small- and large-molecule drug
systems can be a major distraction to the product
30 | LAB+LIFE SCIENTIST - Dec 2021/Jan 2022
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