Manufacturing Science & Technology Services

The transition from process development to commercial production is critical to success and must therefore be implemented in a targeted and effective manner. 

With experience in process characterization, technology transfers (lab / site to site; transfer from / to CMOs) and process validation, VTU is the ideal partner to bring new products from the pipeline to the market in a timely manner. By implementing the specifications from ICH-Q8 and ICH-Q11 in process development and characterization (risk assessments, test plans, design of experiments; Monte Carlo simulation) through to the design and implementation of control strategies (process control strategy, microbial control strategy, elemental impurities, etc.) Ä.), the requirements for a successful process validation and consequently successful inspection and approval of your product in all major markets worldwide are met.

In order to ensure a problem-free start of production, the MS&T team at VTU scores particularly with its extensive experience in the field of process development and commercial production, as well as process validation, as well as analytical topics such as cQA and specification definition, comparability and stability studies. Together with you, we develop platform strategies, generic study designs and risk analyzes as well as analyzes of existing data for effective and convincing process validation. Embedded in the experience and expertise of a plant planning company, we support you in particular with interdisciplinary interface topics such as risk management, control strategy and technology transfer.

Supported by relevant statistical software, the MS&T team at VTU is not only available for development and characterization, but also after a successful start of production in the areas of Continuous Process Verification (CPV / OPV), as well as continuous process optimization (Continuous improvement) with advice and Act aside. In addition, the organization and preparation for pre-approval inspections (PAI) or other official audits can be completely taken over by VTU.

The know-how of the VTU covers the following areas:Process characterization

• Hypothesis tests
• Design of experiments
• Predictive modeling (Monte Carlo simulations)
• Strategies and studies for scale down modeling
• PC study design and documentation
• PC evaluation and documentation

General process validation

• Generic study designs
• Process Performance Qualification (PPQ) - Consistency runs
• Leachable & extractables studies
• Mixed studies
• Microbial control strategy / Bioburden Control Risk assessment
• Process control strategy (ICH Q11)

USP process validation

• LIVCA
• Media stability

DSP process validation

• Impurity clearance studies + assessments,
• Cycle studies for chromatography resins,
• Buffer stability, stability studies for intermediates
• Filling homogeneity, drug substance (DS), freezing studies
• Reprocessing studies

Continued / Ongoing process verification and continuous process optimization

• Implementation of CPV / OPV strategies
• Definition of alert & action levels and baseline variability
• Process capability analyzes and periodic data reviews
• Definition of "adverse trends" and identification of "special cause variability"
• Continuous process optimization

Technology transfer

• Lab-to-Site / Site-to-Site
• Transfer to CMO
• Gap Analyzes / Site Readiness / Risk Assessments
• Management & coordination of interdisciplinary teams