virtual pharma company, a phase ii project | an albemarle fine chemicals case study
TRANSCRIPT
The challenge:Can you improve the yield and impurity levels while
streamlining the production process?
How we said yes:Baseline Experimentation revealed impurity and
yield problems and an R&D program was launched
to address the issues.
STEP 1: Reduce cycle time:
• Reduced extractions from five to three, with no
yield impact
• Increased the concentration of all extraction operations
to minimize product partitioning, decrease cycle time,
and increase throughput
• Identified a material of construction incompatibility that
caused a 50% reduction in yield, and a corresponding
increase in impurities
STEP 2: Improve yields: Supplied process was not
reproducible; the reaction would not always reach
completion.
• Instituted a reverse order of addition that consistently
delivered reaction completion
• Added a pH adjustment to the end of the workup that
significantly increased yield
STEP 3: Reduce impurities:
• The kinetics of the reaction was studied, which allowed
for the reaction time to be reduced by 50%
• The parameter study also showed that diluting the
reaction concentration increased the yield by 5-10%,
and reduced impurity levels.
• Crystallization conditions were identified and
implemented to almost completely remove two
troublesome impurities
The yes formula benefits:Throughout the development and production
of the project, weekly, and occasionally daily
communications with the customer took place.
This allowed the customer the opportunity to
shape the direction of the research, if desired.
Product was produced at scale. All quality
expectations were met or exceeded.
Project completed at our South Haven facility.SEE BACK FOR DETAILS
Fine Chemistry Services
Case Study A: Virtual Pharma Company, A Phase II Project
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customer product development
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and chemistry capabilities
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development in a FDA-regulated facility
The information presented herein is believed to be accurate and reliable, but is presented without guarantee or responsibility on the part of Albemarle Corporation. It is the responsibility of the user to comply with all applicable laws and regulations and to provide for a safe workplace. The user should consider any information contained herein, including information about any health or safety hazards, only as a guide, and should take those precautions that are necessary or prudent to instruct employees and to develop work practice procedures in order to promote a safe work environment. Further, nothing contained herein shall be taken as an inducement or recommendation to manufacture or use any of the herein described materials or processes in violation of existing or future patents.
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