Page is loading, just a sec...

STRENGTHs

This is what makes us deliver

STRENGTHs

This is what makes us deliver

Your benefits

Cycle time reduction

3% - 25%

Productivity increase

3% - 10%

Profit increase

2% - 5%

Time to market reduction

Up to 2 year


We concentrate only in the most difficult & complex projects, and in critical stages of:

  • Clinical Supply
  • Late Stage Development
  • Industrialization
  • Commercial Manufacturing

We assist companies with our unique capabilities and proprietary strategies in:

  • Lifecycle Management (CPV) using massive amounts of process and quality data, from development and/or manufacturing.
  • End-to-End Analysis (advanced CAPA) for Troubleshooting & Increased Process/Product Knowledge.
  • Extracting much more from already existing & paid data: Bioanalytics, Bioengineering and Pharmacological Performance Data.
  • Proactive Implementation of New Regulatory Initiatives: Quality Risk Management (QRM), Comparability of BioProducts Subject to Changes in Manufacturing and 'Established Conditions’ to revised Quality Commitments.

4Tune Engineering Cross-functional strengths ensure that together with its clients, we create better therapeutic outcomes for patients:

  • more predictable
  • higher quality consistency and
  • with lowered safety risks
Our network

FDA - Food and Drug Administration

The common goal of this partnership is to work on the awareness of new production and quality standards. How? Providing development training.

ISPE – International Society for Pharmaceutical Engineering

We are long-lasting members and contributors of the most recognized body in pharmaceutical engineering in the world.

IFPAC – International Foundation Process Analytical Chemistry

Since 2016 our CEO José Cardoso Menezes is co-chairman of the largest IFPAC event about production and quality for the pharmaceutical industry.

Our references

Predicting Mab production yield from Raw-Materials

Hakemeyer C, Strauss U, Werz S, Jose GE, Folque F, Menezes JC (2012) Predicting MAb product yields from cultivation media components using NIR spectroscopy. NIRNEWS 23(6),4-7. – Predicting Mab production yield from Raw-Materials.

request more details

Coating in-line monitoring for end-point determination

Moeltgen CV, Puchert T, Lochmann D, Menezes JC, Reich G (2012), A novel in-line NIR spectroscopy application for the monitoring of tablet film coating in an industrial scale process. Talanta 92, 26-37. – Coating in-line monitoring for end-point determination.

request more details

Online PAT monitoring for Mab cultivations

Hakemeyer C, Strauss U, Werz S, Jose GE, Folque F, Menezes JC (2012) At-line NIR Spectroscopy as Effective PAT Monitoring Technique in Mab Cultivations During Process Development and Manufacturing. Talanta 90, 12–21. – Online PAT monitoring for Mab cultivations.

request more details

Welcome to 4Tune Engineering

Read a short message of our CEO José C, Menezes, PhD

Read More
NEWSLETTER
Subscribe our newsletter and stay tuned.