Seqens eBook - 34

How Do You Ensure a Smooth
Technology Transfer in
API Manufacturing?
It's All About Collaboration
Ed Price, CEO, Seqens CDMO North America
Effective technology transfer protocols share the knowledge
and capability of a given API manufacturing process and lay the
foundation for the next stage of development. They also enable
Contract Development and Manufacturing Organizations (CDMOs) to
plan, allocate resources and successfully complete the work.

The process of technology transfer
can be a time-consuming and
complex one that takes teamwork,
communication, and most
importantly, the ability to anticipate
and resolve potential obstacles that
could arise during technology transfer.

Manufacturers of Active Pharmaceutical Ingredients (APIs) often
must transfer technology to another site or firm, or have technology
transferred to them. But how can they rest assured that in the process,
critical information is not lost and that valuable time is not wasted
in the switch? This is where technology transfer comes into play.
Having a proven technology transfer protocol in place can make a
world of difference - not only in ensuring a smooth process, but also
in helping to win the confidence and trust of the sponsoring firm, as
well as other contractors involved with the project.
Yet, the process of technology transfer can be a time-consuming
and complex one that takes teamwork, communication, and most
importantly, the ability to anticipate and resolve potential obstacles
that could arise during technology transfer. Often, a chemical process
is being transferred not only to a different company with different
processes, internal protocols and staff, but it can often be the transfer
of a project from a Contract Manufacturing Organization (CMO)
located overseas which may have its own set of processes, regulations
and ways of doing business.
Regardless of the transfer location, key considerations can ensure a
smooth and effective technology transfer.

Saving Time and Money with Strong
Sponsor/CMO Partnership
Perhaps one of the most critical requirements of an effective
technology transfer is effective communication and sharing of
information from the sponsoring organization. Sponsors should
openly share batch records, as well as information on obstacles and
Pharmaceutical Outsourcing |

challenges along the way. They should not hold anything back.
Often, the CDMO is being hired when an overseas or another
manufacturer failed, so the project can be seriously delayed, with lots
of time and money already having been spent. As much as possible,
organizations should strive to not reinvent the wheel, but work to
leverage already accrued knowledge to move the project along as
quickly and accurately as possible.

Detailed Process Summary
Assuming that the raw materials and Active Pharmaceutical
Ingredient (API) remain the same and are procured from the same
supplier, a technology transfer usually begins with an assessment of
the original manufacturer's information -- from raw materials through
critical process parameters.
Good CDMOs work hard to develop transfer protocols in such a way
that critical steps and even equipment differences are adequately
34

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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
Seqens eBook - 8
Seqens eBook - 9
Seqens eBook - 10
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Seqens eBook - 12
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