ignore the data for the sake
of rushing towards the
end. Believe the data, act
upon the results, improve
or change the process if
If the blend uniformity
data are borderline passing,
it will only get worse when
the product is launched.
You’ve got to fix the issues
before submission and
validation. A poorly devel-
oped process will result in
challenges and potential
rejections post launch,
which will be costly in the
Launching then not being
able to supply the market
due to process issues is
way costlier and image
damaging than producing
a couple more experimen-
tal qualification batches,
which may take an addi-
tional three months on
the development timeline.
Update your resume if this
Q: Can you give an exam-
ple of a tech transfer gone bad? What went wrong?
What delays and additional costs were faced?
Technology transfer and product introduction of
a triangular shaped tablet. Soon after the launch, com-
plaints poured in regarding chipped and broken tablets.
Investigation into the issue revealed that already during the
development and validation phase, the friability data for the
triangular shaped tablet was on the high side.
It was noted as such in the validation reports, but for the
sake of expediting the launch, it wasn’t addressed at that
point. Complaints about broken tablets also reached the
agency, which in turn wanted to have an explanation from
the company as to the root cause and corrective action.
In short, the tool design for the triangular shape was not
optimal. Together with the tool manufacturer the dimen-
sions of the thickness and the curvature of the corners were
redesigned, which gave the tablet a more robust shape.
This, however, required additional stability studies, as well
as an update to the original filing documents.
In general, tech transfers should not go bad in the 21st
century considering that most of the developing companies
are following Quality by Design
Q: What’s the key to making
a successful tech transfer?
It comes down to
good communication. To this
day we’ll transfer a very unique
product into a facility, every-
body understands what the
formulations are, then some-
one will say, ‘my goodness,
it is hard to clean.’ You knew
what the agreement was. Don’t
come back with a show-stopper
six months into the process
and say that’s a deal breaker?
That’s as good as saying the
product doesn’t work.
There’s give and take. It’s
business collaboration and
should be openly discussed
with the client. It should be
a quality working agreement
between the firm that is trans-
ferring it, such as a Big Pharma
company, and the one accept-
ing it, such as the CMO,
so there are no surprises in
Otherwise, it becomes a ‘war story’ because there was
no conversation about a particular issue and it falls off the
track as though the product itself didn’t work.
Q: Do companies follow a standard set of industry
guidelines for tech transfer or do they set their own
metrics? Does the FDA get involved?
Not guidelines, per se, but the FDA will send
inspectors, who look for and follow a list of components,
specifications, process tests, manufacturing procedures,
and solution data. As they go down the list, if the company
hasn’t combined its collective knowledge during the tech
transfer process to address the various steps during the Pre-
Approval Inspection, the tech transfer is going to be a flop.
People think it’s all about the validation. Yes, it’s a man-
dated requirement, but remember that the FDA is always
going to look at Good Manufacturing Practices (GMP) and
the various steps for pre-approvals. That’s your guidance.
I think people get wrapped up in QbD, which is extremely
helpful but it’s an enabler. Tech transfer is a component in
the whole QbD concept. It is all about the knowledge that
you have to make the product, to educate the participants,
in this issue
Click to subscribe to this magazine
article text for page
< previous story
next story >
Share this page with a friend
Save to “My Stuff”
Subscribe to this magazine