Search results for " patients"
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Simulation gets therapies to patients faster and smarter
Digital solutions are helping to decrease therapeutic time to market but remain challenging – learn how we work on overcoming that challenge!
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New Therapies Present Scaling Challenges
Autologous cell therapies use a patient’s own cells for the threapy, while allogenic cell therapies use cells from a donor to develop a therapy to treat multiple patients. Specifically, autologous cel…
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Biosimilars: Making the Switch Comes with Challenges
There continues to be widespread scepticism in the region about the quality and safety of biosimilars, and sometimes their efficacy, among physicians and patients. This issue is often because of a lac…
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Biopharma Seeks Balance
The high cost of making adenoviral vectors (AVV), however, will limit the use of such therapies to treat large populations of patients with common diseases. Developing sufficient quantities of a gene …
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Patenting Prospects for Cell-Based Therapies
It is also one that involves significant investment and, therefore, can be expected to have concomitantly significant costs to patients and their insurers. Accordingly, patent exclusivity will be impo…
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Advances in Engineering of Protein-Based APIs
…y therapeutics (such as trastuzumab, pembrolizumab, and romosozumab) to the clinic and ultimately to patients. Humanized antibodies may also have improved safety and immunogenicity profiles, which is…
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Understanding Validation and Technical Transfer, Part 3
When correctly done, linking process to product to patient, validation ensures safe and effective drug and biologic products and benefits the patients whose health and wellbeing depend on them.
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Quality by design for biotechnology products—part 1
Validation and implementation of drug-dependent antibody assays in clinical trials for safety monitoring of patients dosed with roxifiban, an orally bioavailable glycoprotein IIb/IIIa antagonist. J Ph…
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Science Focus Fuels Successful Process Development for Startups
…bone marrow taken via apheresis; clinical manufacturing deals with starting materials collected from patients with various diseases, sometimes with complex medical histories or medication profiles th…
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Manufacturing Standards Key to Advancing Cellular and Gene Therapies
…cience and strategies for facilitating development of therapies able to generate, repair, or replace patients’ tissues. A June 2017 workshop on “Navigating the Manufacturing Process and Assuring the …