Seqens eBook - 35

API

challenged. It may be necessary to develop new operating procedures
for the product, in which case one or more batches may be required
at this stage. The more thoroughly a process is challenged in this early
phase, the more robust that process will be moving forward to ensure
reproducible quality. This information is included in a validation
report, which is essential to FDA approvals.
If possible, a good practice is to have manufacturing engineers work
directly with the technical manager during optimization and scaleup, to ensure that there is effective communication and collaboration
through all the critical steps, before being transferred to a Good
Manufacturing Practice (GMP) suite. Working together the process
chemists and GMP specialists would all be on the same page when
it comes to the raw materials being used, writing the master batch
record for the process to be introduced and ensuring the appropriate
analytics are in place.
Once the detailed process summary is in place, the R&D chemists
should come to the GMP suite to help get the scale-up process started,
working with the engineers to make sure the right equipment, vessels
and other instruments are used to run the process.
At each stage this type of on-site collaboration should occur whenever
possible so that everyone has the same information and can operate
as a team.
Pharmaceutical Outsourcing |

Other considerations for effective technology transfer, include:
Safety. With any large scale manufacturing business, one of the most
important aspects of process development is attention to safety.
During technology transfer, a meeting between the R&D team,
engineering team, and the health & safety team must occur in order
to determine possible dangerous scenarios during manufacturing.
Some chemicals can be hazardous to the operators who are managing
the reactor vessels, so extra care must be taken to protect them.
Cleaning. Since it is difficult to have equipment dedicated to certain
processes, during technology transfer there must be a method for
cleaning the residues generated by each process. This ensures that
after a successful campaign, the equipment can be changed over
to be used in the manufacturing of a different product. Developing
a cleaning process includes identification of an effective cleaning
solvent, noting areas inside the equipment that are difficult to clean,
and developing a way to successfully identify the residues inside of a
cleaning sample.
Effective technology transfer is both integral and critical to drug
discovery and development for new chemical products. As companies
increasingly turn to CDMOs for drug development and manufacture,
ensuring a continuum of excellence in each stage of the process,
with properly recorded and documented activities is key to seamless
operations, as well as long-term success.
35

| pharmoutsourcing.com



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Seqens eBook

Table of Contents for the Digital Edition of Seqens eBook

Contents
Seqens eBook - 1
Seqens eBook - Contents
Seqens eBook - 3
Seqens eBook - 4
Seqens eBook - 5
Seqens eBook - 6
Seqens eBook - 7
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