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Enabling / Scale-Up: From Lab Process
to Pilot Process
From lab process to pilot process,Chemrio develops a safe,
scalable and robust pilot process. Depending on our clients'
need for support, we develop the release analytics, ensure
the scalability and robustness of the process and solve
any remaining technical or sourcing related issues.
Our goal: To provide a proven pilot process that can produce
safely and efficiently the first batches of APIs to support
clinical trials (up to Phase III).
At a minimum you can anticipate the following outcomes
as a result of your input combined with our activities:
Input
 Lab
process
Quantitative
analytical data (e.g. NMR, IR, UV, MS etc.)
IPCs
Activities
Evaluation
of scalability and robustness of the process
Technical
issues
Safety
assessments
Sourcing
Analytical
method development for release
Output
GMP:
Master Operation Record (MOR)
GMP:
validated method for release
Preclinical
GMP: detailed report
Samples
and/or references
g
to kg amounts
Rapid Supply of Intermediates: Intermediates for Research
Support through to Phase III Clinical Trials
In the production phase, Chemrio implements the developed
process in the pilot plant. We ensure that the level of
development is adequate to support the scale of the reaction
and the regulatory requirements are adequate for the end-use
of the material produced. Typical batch sizes range from
50 kg to 1000 kg.
Our goal: To safely supply, as rapidly and efficiently
as possible, the first batches of APIs to support early
clinical trials (up to phase III).
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