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VTU Engineering GmbH sell "Manufacturing Science & Technology"

Basic Information

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Trade Type

Sell

Product Name

Manufacturing Science & Technology

Manufacturer(s)

Specifications

  • Application: Supports the transition from late-phase process development to commercial biotech manufacturing, helping products reach regulatory approval.
  • Country of Origin: Austria, Germany, Switzerland
  • Certification Standard: Used to support Chemistry, Manufacturing, and Controls (CMC) documentation and regulatory submission activities for biologics.

Other Information

Additional Description:

VTU Engineering's Manufacturing Science & Technology group supports development and production teams through the later stages of biotech product development and commercialization, serving as an experienced partner to help products reach approval. The transition from late-phase process development to commercial manufacturing is a pivotal and often complex step toward a successful launch, and the group brings deep experience in process characterization, including risk assessment, study design, design of experiments, and Monte Carlo simulation, alongside technology transfer between labs, sites, or CMOs, and process validation, applying ICH Q8 and Q11 guidelines, Quality by Design principles, and effective risk management and control strategies to bring pipeline products to market promptly.
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