How to start a Biosimilar development – a risk-based approach

Daniel AmstutzKnowledge, NewsLeave a Comment

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.

TEMIS is here!

Daniel AmstutzNews, Promo

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.

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Advisor for TU Hamburg in BMBF project

Daniel Amstutzcompany update, News

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.
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Partnership with Exputec GmbH

Daniel Amstutzcompany update, News

cooperate

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.
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