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ROUNDTABLE

simultaneously. In addition, scale-up involves running the process
longer or with more identical setups in parallel, eliminating the need
for tech transfer and reducing commercialization times.
Matos: We believe that continuous manufacturing will have a
very important role in pharmaceutical manufacturing. There are
a number of trends to reduce development time and costs, as well
as a growing number of candidates with accelerated development
designations (Fast Track, Breakthrough Therapy, Orphan Drug) that
will shift the critical path to the CMC section, getting new therapies
to market earlier. Continuous Manufacturing of Oral Dosage Forms,
e.g. Continuous Tableting, offers the opportunity for much less effort
in scaling-up as the same equipment can be used for development,
clinical supply, and commercial manufacturing.
In addition to decreased development lead times, continuous
manufacturing can also deliver on the promise of processes that are
more efficient and with more consistent quality. The generation of high
amounts of data during the several stages of the process lifecycle via
process instrumentation and/or Process Analytical Technologies (PAT)
enhances the ability to monitor or control the continuous operations.
Furthermore, a data-rich environment better supports the adoption
of Real Time Release testing (RTRt) for increased assurance of quality.
Pharmaceutical Outsourcing |

It's fair to say that the future is happening now. More and more
companies have programs in place, or are about to start, in order
to gain increased capability and install the capacity for continuous
manufacturing. We have noticed a favorable combination of
regulatory support, mature technology, better software and more
advanced automation systems, all aligning to make continuous
manufacturing a possibility and a success.
Gregory: Key industry trends, including rising cost pressures,
increasing expectations for patient-centric medicines and the
need to reduce time to market will continue to drive demand for
cheaper, more effective manufacturing solutions that provide
safe and efficacious drugs while also providing value for investors.
However, consolidation within the CDMO industry may drive out
smaller players and limit the availability of CDMOs, thereby driving
higher costs for customers. Greater quality demands by clients and
the FDA will drive CDMO overhead higher as well, adding to the
barriers for entry into the outsourcing market for new players. Under
these various conditions, close collaboration between supply chain
partners will be an important part of the future of oral solid dose
manufacturing. Improving efficiencies and reducing costs cannot be
achieved without dialogue and understanding between all members
of the pharma industry supply chain.
25

| pharmoutsourcing.com



http://www.pharmoutsourcing.com

Seqens eBook

Table of Contents for the Digital Edition of Seqens eBook

Contents
Seqens eBook - 1
Seqens eBook - Contents
Seqens eBook - 3
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