Search results for " patients"
Article
Ensuring the Biological Integrity of Raw Materials
…icant source of contamination, which can lead to false research results and a serious health risk to patients receiving the product.
Contamination of biologic drugs and vaccines by adventitious a…
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Managing Risk in Raw Material Sourcing
Risk management is the key to avoiding batch failures, as well as adverse effects in patients, she explained. IPEC has developed standardized templates and materials to help simplify supplier evaluati…
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Real Time Continuous Microbiological Monitoring
… but could potentially grow as an opportunistic infection under special conditions found in clinical patients.
The development of such instrumentation capable of providing an evaluation of microb…
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Managing Biomanufacturing Capacity Expectations
Capacity for complex therapeutics is becoming increasingly difficult to predict.
By Randi Hernandez
Demand for any given new product is typically only known after significant investments h…
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Vaccine Development Faces Urgency and Challenges
The design of new antigens based on molecular structure and advances in synthetic biology will help deliver new vaccines to patients, noted GlaxoSmithKline (GSK) Chief Scientist Rino Rappuoli at the P…
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Innovative Therapies Require Modern Manufacturing Systems
FDA and industry see progress and challenges in bringing cutting-edge medicines to patients.
By Jill Wechsler
FDA set a 19-year record in 2015 in approving more new drugs and biologics, and …
Article
Antibody Production in Microbial Hosts
…half-life of 25 days (comparable to the wild-type glycosylated form) and significant improvements in patients with rheumatoid arthritis (45). Recent success in aglycosylated IgG production and clinic…
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Tools for Continuous Bioprocessing Development
Consider the case of Myozyme (alglucosidase alfa), a lysosomal glycogen-specific enzyme indicated for use in patients with Pompe disease. In 2008, FDA rejected Genzyme’s application to produce Myozyme…
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Biopharma in 2015: A Year for Approvals and Innovations
mAbs show promise in treating Alzheimer’s, lymphoblastic leukemia, and are playing a role in helping to improve survival of patients with multiple mueloma.
Last year was also a year when novel biop…
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GMP Challenges for Advanced Therapy Medicinal Products
Finalizing GMP requirements and quality standards for the development, manufacture, and clinical testing of ATMPs in the EU is proving to be a complex task.
By Sean Milmo
A consultation period…