Seqens eBook - 24

ROUNDTABLE

How has the globalization of the pharmaceutical
industry affected oral solid dosage manufacturing?
How do you ensure that products manufactured
meet individual country regulations?
Childers: The globalization of the pharmaceutical industry has
not affected oral solid dosage manufacturing. With the continuing
harmonization of the regulatory standards, the ability to supply
multiple regulatory bodies is more simplified. The challenge
centers around ensuring the products manufactured comply with
the individual country regulatory filing. This can become difficult
when different testing criteria are the limiting factor. Products
should be produced and tested for the intended market. A method
would be to align all specifications and manufacturing processes
to the most stringent specification. This method removes the initial
issue, but maintaining alignment of multiple individual filling can
be problematic. Another method is to have individual process
records and specifications for each country. This method requires
maintenance of multiple documents and there is little flexibility for
the supply chain with double the number of product presentations.
The right approach would be a mixture of the two methods discussed.
The mixture will depend on the number of individual countries and
the complexity of the specifications.
Gwenaël Servant, Managing Director, Servier: When a drug
innovator wishes to find the ultimate development partner, a CDMO
that is embedded within a global pharmaceutical company brings
certain advantages - as is the case with CDMOs that have 'embedded
expertise' in process development, scale-up, analytical method
development, and regulatory compliance. This is also true of CDMOs
that possess a global network of manufacturing plants across the
globe that provide optimized time-to-market with significant cost
savings, while responding to the demand of authorities to produce
locally. If API production can be done anywhere, OSD forms can
be less global, with clients expressing a preference for local (or
regional) manufacturing.
At Servier, the concept of embedded expertise also includes
project management, quality and reliability. Without effective
project management, quality systems and a culture of continuous
improvement, it is not possible to be a fully optimized time-tomarket organization. Servier has developed a global quality systems
management (QSM) infrastructure that proactively assures the
implementation of quality assurance/quality control best practices in
each of its sites. With R&D, manufacturing, analytical and regulatory
capabilities located within the same facility, we can take client
projects from concept to approval and on to clinical trials. We also
rapidly take developed processes to production, and handle transfers
from one site to another with dedicated teams.

What do you see as the future of oral solid
dosage manufacturing?
Childers: There will be a rise of biosimilars and biologics
manufactured as solid oral dosage forms. Today, oral solid dosage
Pharmaceutical Outsourcing |

forms are the highest priced medicines and the oral route has proven
to be the most problematic route of delivery, but as new formulation
technologies are developed that protect biomolecules from the
upper GI tract and increase bioavailability there will be a rapid rise
in approvals and usage in the market. These new technologies may
also spur an increase in the number of reformulated BCS Class II and
IV products for which the oral route was formerly abandoned due to
poor bioavailability.
Dave DiProspero, Director of Pharmaceutical Process Technology,
CRB: There are few sectors in pharma that do not have some stake
in OSD innovation and development. From branded, generic and
OTC producers - and throughout the supply chain's contract service
and equipment providers - few are expecting anything less than
continued growth and investment in this key dosage form delivery
category. The industry understands that reformulations, combination
drugs, bioavailability technologies and complex layered formulations
will continue to fuel OSD sector growth and manufacturing innovation
for the next several years.
For companies seeking a future in OSD manufacturing, it's clear
they're going to have to be more flexible and efficient than they are
today. How to get there? By innovating - introducing new processing
concepts such as continuous processing, integrated processing
trains, process analytical technology - and pulling it together with
a facility design that pays careful attention to modern and efficient
flows, safety, ergonomics and output capacity flexibility.
As drug innovators and manufacturers navigate the pharma 3.0
landscape, they are increasingly tasking manufacturers to lower their
costs via improved efficiencies. The OSD "Facility of the Future" must
move beyond its age-old traditional inefficient batch operations
roots. Pharma's uptake of state-of-the-at processing, modern facility
designs and technology is accelerating, and recent progress is
already making an impact on pharma's ability to fulfill its current
commitment and future potential to varying and individualized
patient drug needs worldwide.
Ed Godek, Manager, Process Technology, Glatt Air Techniques,
Inc.: Pharmaceutical production in general is moving toward
continuous manufacturing, and OSD manufacturing is no exception.
Both sponsor firms and CDMOs are interested in continuous
manufacturing because it is possible to reduce process times, waste
and cost. For instance, the continuous process requires about 8% of the
space of a batch process with powder feeding from a mezzanine into
a high-shear granulator and then into the fluid bed and tablet press.
Glatt has been working with universities and other entities to develop
more science around continuous manufacturing. The company is also
focusing on the application of process analytical technology (PAT)
for continuous manufacturing. Realtime data about a process is
needed to adjust the process conditions using feed-forward and feed
backward controls in order to ensure continuous production of highquality product. Examples include online determination of moisture
content and particle size during granulation. Development times
are compressed because the process is developed at the lab scale
using design of experiments (DOE), with PAT methods developed
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