A few months ago, we’ve released an overall look at TEMIS and were only able to scrap the surface of all its features (go to the TEMIS main page). In … Read More
Following the Biosimilar conference in Boston a few weeks ago, we would like to share our presentation on how to properly start a Biosimilar development project.
We don’t think our approach is unique, in fact far from it, as we refer to Juran’s Quality by Design concept and subsequently to the ICH guidelines Q8, 9 and 10. And we certainly don’t believe that it is the only approach to go forward.
Yet, we believe that our way of looking ahead and be prepared for obstacles is more practical, efficient and economical (in the long run) than the eyes-wide-shut-and-hope-for-the-best approach, which seems to be surprisingly more common than we have thought.
The renowned World Biosimilar Congress is coming up in less than a week. After a highly successful congress last year , the organization committee Terrapinn expects an even bigger impact … Read More
In less than a couple weeks, the 13th International Conference on Biologics and Biosimilars takes place in Boston (USA), on Oct 24/25. Most of the keynotes and panels are touching … Read More
With TEMIS ready to be rolled out, we are now taking the next step in our product development endeavours: Project ATLAS shall give small, young organizations a head-start in their attempts to go fully GMP-compliant. An initial funding was granted by Innosuisse, the official Swiss Innovation Agency.
Our software solution TEMIS is now available for implementation!
TEMIS fills a gap in the pharmaceutical industry for an affordable, yet powerful GMP-compliant document management system.
Enterprises in the industry are required to comply with exceptionally high regulatory requirements, for their products have a significant impact on human life, whether directly or indirectly.
QBDC GmbH has been recruited as an advisor on GMP topics for a BMBF project by the Hamburg University of Technology (TUHH). A consortium around Prof Ralf Pörtner and Johannes Möller of IBB at TUHH develops a novel DoE Software for improved process development in the biotech industry.
Read more …
EXPUTEC GmbH and QBDC GmbH have agreed to form a mutually beneficial business partnership to cooperate in the field of bioprocess organization and GMP compliant document and data management.
By September 2018, inCyght bioprocess software by Exputec will have a certified interface to TEMIS cGMP compliant document management software by QBDC.
Read more …
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