Virtual Pharma Company, A Phase II Project | An Albemarle Fine Chemicals Case Study
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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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Transcript of Virtual Pharma Company, A Phase II Project | An Albemarle Fine Chemicals Case Study
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
Find out how we say yes to hundreds of fine chemistry projects annually.
Albemarle is experienced and equipped to provide high-quality APIs to pharmaceutical customers worldwide.
To experience the difference of a committed fine chemistry partner, contact your Albemarle Representative.
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• More than 32 years service in pharmaceutical
and chemical industry
• Substantial R&D and new product
development resources
• cGMP kilo lab and pilot plant to support
customer product development
• Extensive custom manufacturing equipment
and chemistry capabilities
• On-site analytical support and methods
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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