The transition from late phase process development to commercial production is a crucial step towards a successful product launch and therefore has to be performed in a straight-forward and effective manner.
With extensive experience in Process Characterization (Risk assessment, Study Design, Design of Experiments, Monte-Carlo Simulation), Technology Transfers (Lab/Site to Site; Transfer to/from CMOs) and Process Validation the MSAT group of VTU Engineering will enable you to get your pipeline products to the market promptly. By implementing the ICH-Q8, ICH-Q11 guidelines, Quality by Design, an effective Risk Management System and effective control strategies (Process Control Strategy, Microbial Control Strategy, Elemental Impurities), all requirements for a quick approval of your product on all major markets worldwide are met.
In order to achieve a smooth start of production, the MSAT group also provides extensive experience in the areas of Process Development, commercial manufacturing and Process Validation, as well as analytical topics like cQA, definition of specifications, comparability- and stability studies.
In a coordinated team-effort with developers and production personnel the VTU MSAT group may provide you with a solid platform strategy, generic study designs, risk analyses as well as analyses of any existing data, resulting in a convincing Process Validation strategy. Embedded within the experience and expertise of a plant engineering company we are especially capable of supporting any interdisciplinary tasks regarding Risk Management, Control Strategies and Technology Transfers. Applying sophisticated statistic approaches, supported by various statistical software tools, VTU also supports your commercial production by implementing Continuous Process Verification (CPV/OPV) and Continuous Improvement tools. In addition the organization and preparations prior to pre-approval inspections (PAI) or other audits can be managed by VTU.
The Know-How of VTU covers all the following aspects:
Process Characterization
- Hypothesis testing
- Design of Experiments
- Predictive modelling (Monte-Carlo simulations)
- Strategies/Study design for Scale Down Modelling
- PC Study designs and documentation
- PC Reporting
- Process Validation general
Generic Study Designs
- Process Performance Qualification (PPQ) - Consistency runs
- Intermediate hold studies
- Leachable & extractables studies
- Mixing studies
- Reprocessing
- Microbial control strategy
- Process control strategy (ICH Q11)
USP Process Validation
- LIVCA studies
- Media stability studies
DSP Process Validation
- Elemental impurity clearance studies & assessments
- Resin Reuse studies
- Buffer stability studies, Stability studies for intermediates (Hold times)
- Virus validation
- Filling homogeneity studies
- Drug Substance (DS) freeze-thaw studies
Continued (ongoing) process verification / improvement
- Implementing CPV/OPV strategies
- Definition of alert/action levels and baseline variability
- Process capability analyses & periodic data review
- Definition of “Adverse Trends” and identification of “Special Cause Variability”
- Continuous process optimization
Technology Transfer
- Lab-to-sie; Site-to-Site
- Transfer to CMOs
- Gap Analyses / Site Readiness / Risk Assessments
- Management & coordination of interdisciplinary teams
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