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This white paper highlights six key points that pharmaceutical and biotechnology
companies should keep in mind when looking to select the ideal partner to synthesize an
API for them—and ensure their drug development process stays on the path to success.
1. PUT QUALITY FIRST
The CDMO must have an outstanding track record of identifying and developing
synthetic routes to consistently produce APIs to a high standard. Its process
development chemists will need to be able to (re)assess, tweak, and potentially
completely change the synthetic route the medicinal chemists used to initially
synthesize the target compound. Medicinal chemists and process development
chemists have different goals, explains Craig Dixon, Senior Business Manager at
Patheon, part of Thermo Fisher Scientific. “The primary goal of medicinal chemists is
to make compounds,” he says. “They’re not necessarily focused on how they get to
the compounds.” Process development chemists need to be able to consistently make
APIs that meet strict quality and regulatory requirements both efficiently and safely.
An important point is the need to ensure that the CDMO is capable of developing
and understanding a manufacturing process that consistently produces the same
impurities at the same very low levels. “If your chemistry’s out of control, you’re going
to see variations in the levels of known impurities, and unknown impurities might
begin to appear at times too,” Dixon says.
It’s also important that the CDMO is able to think ahead and ask: Will the route being
designed for the first small, preclinical study batch also perform well on a commercial
scale? Optimizing or changing a manufacturing route as batch size increases can
lead to questions about the preclinical toxicology study results. “The impurities can
change as the chemistry changes,” Dixon says. “There is a toxicology impact of
changing the chemistry late in the game.” This can mean redoing early safety studies,
which will cost time and money.
A late change will also affect any analytical chemistry techniques required to assess
the drug’s quality. “Analytical methods can be very specific to certain impurities,”
Dixon says. “New impurities resulting from a route change may not be detected
by existing analytical methods.” It may be necessary to go back and redevelop, or
revalidate, analytical methods. “Getting the route of synthesis right early on minimizes
those headaches down the road,” he adds.
Continue at: https://vertassets.blob.core.windows.net/download/cf4cc018/cf4cc018-072b-4044-bc21-43c857694377/whitepaper_api_synthesizingsuccess.pdf
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