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If you manufacture or develop pharmaceuticals, CWB Tech can help you to improve
your processes. No matter what your position is in the pharmaceutical industry,
whether you are a brand name or generic drug maker,
make only the API, or
pharmaceutical intermediates, having a robust
and economic process will bring you many benefits and fewer operational headaches.
Big or Small Pharma
Clearing regulatory hurdles, especially when new clinical testing is involved,
is highly expensive and time consuming. Due to stiff regulations, the incentive to
modify a pharmaceutical process after it has been submitted for regulatory approval is
low. This situation does not mean that time is wasted on
process development. Rather, it highlights the necessity and importance of
good process development early in the drug lifecycle. The process must be
designed correctly at the beginning.
Otherwise we will face the consequences of two great adversaries:
- Delay in the market introduction of a product because of technical difficulty.
- Inability to compete with lower cost manufacturers once the patent protection
has expired.
Benefits of Good Process Design
The benefits of a good process development and design will positively impact your business
in many ways.
- Better knowledge and understanding of your process yields better patent protection.
- Lower manufacturing cost improves your profit margin.
- Fewer operational problems produce less off-spec material and lower raw material cost.
- Reduced waste means less treatment, disposal, and fewer possibilities of exposure to humans.
CWB Tech can work with you in the following areas:
- Conceptual Design
- Objective: Determine what is feasible and what is infeasible starting with the raw
material and ending with the finished product. Determine which of the feasible processes
is most likely the economic winner.
- Value Added: A well thought-out and optimized manufacturing process.
- Workflow
- Objective: Allocate and optimize your process development resources.
- Value Added: Better, faster, and cheaper process development results.
- Crystallization & Solids Process Optimization
- Objective: Design, optimize, or troubleshoot the crystallization for product
purity, recovery, or solids processing operation.
- Value Added: Produce the right polymorph, Require fewer recrystallizations, Lose
less raw material, Improve uniformity in tableting.
- Separation Process Synthesis
- Objective: Generate the best separation alternative.
- Value Added: Lower cost solvent recovery, Higher product purity and yield.
- Reaction Engineering/Scale up
- Objective: Design the best (multiphase) reactor combining experimental work,
synthesis, analysis, and scaleup. Validate that the results are consistent with
the proposed reaction scheme.
- Value Added: Better reactor and reactive separations performance.
- Software: SLEEK, Solid-Liquid Equilibrium Engineering Kit
- Objective: Software toolkit from CWB Tech for crystallization.
- Value Added: Better understanding and better design of crystallization processes.
When Should I Call CWB Tech?
The ideal starting time of any project in the process R&D phase is when
you have gained some level of understanding about your reaction chemistry or
biochemistry, such as some basic information about reaction performance
and effluent stream composition.
API and Intermediates Manufacturing
We understand that you are facing some serious and increasing competition.
Let our technologies help you to stay in the lead.
CWB Tech can work with you in the following areas:
- Conceptual Design
- Objective: Determine what is feasible and what is infeasible starting with the raw
material and ending with the finished product. Determine which of the feasible processes
is most likely the economic winner.
- Value Added: A well thought-out and optimized manufacturing process.
- Workflow
- Objective: Allocate and optimize your process development resources.
- Value Added: Better, faster, and cheaper process development results.
- Crystallization & Solids Process Optimization
- Objective: Design, optimize, or troubleshoot the crystallization for product
purity, recovery, or solids processing operation.
- Value Added: Produce the right polymorph, Require fewer recrystallizations, Lose
less raw material, Improve uniformity in tableting.
- Separation Process Synthesis
- Objective: Generate the best separation alternative.
- Value Added: Lower cost solvent recovery, Higher product purity and yield.
- Reaction Engineering/Scale up
- Objective: Design the best (multiphase) reactor combining experimental work,
synthesis, analysis, and scaleup.
- Value Added: Better reactor and reactive separations performance.
- Troubleshooting
- Objective: Apply a clear engineering or scientific foundation to eliminate
a manufacturing problem.
- Value Added: The particular problem is mitigated. Understanding is provided
for the prevention similar problems in the future.
- Software: SLEEK, Solid-Liquid Equilibrium Engineering Kit
- Objective: Software toolkit from CWB Tech for crystallization.
- Value Added: Better understanding and better design of crystallization processes.
Learn more about our services.
Please contact us to find out
how to proceed with a particular project or process development problem.
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