Search results for " patients" in Articles / App Notes
Article
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…
Article
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…
Article
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…
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Selecting the Right Viral Clearance Technology
By Cynthia Challener, PhD
The introduction of adventitious viral agents is a recognized, inherent risk of biologic drug production that is well addressed by international regulatory requirements…
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Best Practices in Qualification of Single-Use Systems
The author discusses the current best practices in technical qualification of single-use systems.
By Weibing Ding, PhD
Single-use technology has been around for approximately two decades if …
Article
Selecting a Comprehensive Bioburden Reduction Plan
Process maps and risk assessments are among the valuable tools operators can apply to reduce the risk of microbial contamination.
By Randi Hernandez
There are multiple variables to consider …
Article
Cleaning of Dedicated Equipment: Why Validation is Needed
…y removed below a level that has been demonstrated to be acceptable and that does not pose a risk to patients. Cleaning validation is time and resources consuming; however, some companies might prefe…