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Our Knowledge:
Let us show you how our expertise represents a competitive advantage for our partners.
With over 12 years of biologics development and manufacturing experience, the industry is turning to experts at ITS for process development, manufacturing, quality systems, regulatory affairs, and clinical trial design.
- Experience in Process Development
ITS controls many pending and issued patents for proprietary production processes, purification and formulation of gene-based biopharmaceuticals.
- Experience in Scaling-up
ITS has developed large scale methodologies for upstream and downstream production processes, formulations that are safe and stable, and product release assays that support product quality at a large scale.
- Experience in Manufacturing
ITS has produced over X lots of clinical grade biologics.
- Experience in Setting the Standard
ITS owns and operates state of the art cGMP manufacturing facilities selected by the Adenovirus Reference Material Working Group (ARMWG) to produce adenovirus used by researchers worldwide. Major pharmaceutical and biotechnology companies are using this reference material to aid in developing their own products.
- Experience in the Clinic
ITS has participated in over 30 clinical trials worldwide with five clinical stage gene based product candidates, including two Phase 3 product programs.
Our Team:
It doesn’t happen overnight. The team at ITS consists of an extraordinary group of professionals with many years of industry experience covering a full range of disciplines. Whatever stage you’re at in the development process, take advantage of that experience by letting us create a customized project for you. |
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