With the annual meeting of the Parenteral Drug Association coming
up this month, we have elected to feature advances in freeze drying in our the
upcoming first April issue of the Pharmaceutical
Sciences, Manufacturing & Marketplace Report.
Freeze drying, or lyophilization, has been used for many products,
beginning with blood plasma products, antibiotics, and vaccines. As the number
of biologic drugs, and thus parenterals formulations, has increased in recent
years, lyophilization technology has also become more widely used. While the
industry has a better understanding of critical issues today and equipment
capabilities have improved to address some of these issues, there is much that
remains unknown. In addition, as freeze drying is used for greater numbers of
high value products, further technical demands will arise.
Even simple questions – such as when lyophilization is appropriate
– need to be addressed as potential new applications present themselves. There
will be both formulation and process-related issues to consider: protein/nucleic acid stabilization in
the solid state, heat transfer, nucleation, vial fogging, handling of high
concentration formulations, reconstitution, scale-up, characterization and
analysis.
Will new dryer designs address these
issues? Or will changes in formulations be the key? Do excipients have a role?
What new characterization techniques might be of value?
Share your thoughts. Also, please suggest other topics related to
parenteral manufacturing that you feel are not well-covered but could be useful
to our readers – especially on new technologies that others can benefit from.
You are the experts. Help me make the Pharmaceutical Sciences, Manufacturing & Marketplace
Report as valuable a resource as possible.
And don’t forget to sign up for the
eNewsletter here if you haven’t done so
yet.
Cynthia A.
Challener, PhD
Editor
The
Pharmaceutical Sciences, Manufacturing & Marketplace Report
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