We’re happy to announce that we will be joining an international project for the development of a vaccine against SARS-Covid-19.

We’re grateful for the opportunity to join this international project. A vaccine that protects against SARS-Covid-19 will help all our communities feeling safe again and it will support the global health system” says Marcos Domingues, our CEO. “We’re very happy to see that 4TE was selected to take part in this international project thanks to our scientific background, our technical expertise and our know-how of the pharmaceutical industry.

But what will we be doing in this project? Let’s go over it:

Mapping of the process development

In this phase, 4TE performs an assessment of the current state development through a GAP Analysis. From there, a risk assessment analysis will be performed as well as some preventive actions determined.

Scaling-up of the process from laboratorial phase to Pilot-scale

4TE will develop a map of the process focused on Lifecycle Management and Quality Risk Management.

From there, 4TE will characterize the Quality Target Product Profile through the determination of Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs) and Critical Material Attributes (CMAs) among others. This will be done based both in existing and generated data following a Quality by Design Approach.

Defining the Formulation

4TE will then define a set of tests of Process and Formulation to produce batches for Pre-Clinical tests and Phase I Clinical Trials.

In parallel, it will set the relevant parameters of quality that are required for regulatory submission.

Scaling-up of the process from Pilot-scale to GMP Industrial-scale

In this important step, 4TE will define the analytical methods as well as prepare all the documentation and logic of characterization of Process and Product.

Regulatory Submission Support

Finally, 4TE will develop the most adequate submission strategy towards clinical trial authorization. This will include supporting the drafting of the documentation.

About us

4TE was born in 2004 to help improving the manufacturing of the pharmaceutical industry. Since then, 4TE has diversified the range of services and became involved in the efforts to bring Digital Transformation to the industry. 4TE’s proprietary softwares – iRISK™ and iSEE Platform™ – provide substantial improvement to the processes of our industrial clients. 4TE’s team is dedicated to bringing the best solutions to our pharmaceutical, biopharmaceutical and life science clients and helping them improve the world healthcare system.

For More about iRISK™, visit: www.iRISK.com
For more about iSEE Platform™, visit: www.iSEEplatform.com
Connect with 4TE on LinkedIn: www.linkedin.com/company/4tuneengineering
Follow @4TE on Twitter: www.twitter.com/4tengineering

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