UVivatec® virus inactivation, Sartobind® membrane chromatography, and Virosart® filtration represent today's spearheading technologies for quantitative virus and contaminant clearance.
Inactivation of viruses using the UVivatec® technology is based on nucleic acid damage caused by UV-C irradiation.
Virus removal with Sartobind® Membrane Adsorber is based on adsorptive ion exchange chromatography principles.
Virosart® filters provide highest virus safety to the biopharmaceutical product.
Together they form a unique orthogonal platform for state-of-the-art polishing of biopharmaceuticals. Learn more.
21st Century Validation Strategies For Drug Products By Anil Doshi, RPh.,Ph.D., President, Infinity Pharmaceutical Consulting
Any pharmaceutical company that initiates and implements QbD (ICH Q8, Q9, and Q10) effectively and efficiently will fully leverage a competitive advantage in the 21st century. The prudent implementation of this strategy, based on good science and an accurate grasp of the available regulatory knowledge, will create transformational value by providing high product quality assurance for patients, more efficient regulatory oversight, and cost savings for the company.
7 Ways QA Managers Can Guide Executive Management Toward A Quality System By Christine Park, Quality Architech
Executive Management participation and support is key to the successful development, implementation, and management of pharmaceutical quality systems. The FDA guidance document (Quality Systems Approach to Pharmaceutical CGMP Regulations) defines the expectations for management with executive responsibility (MWER). These expectations for MWER are aligned with the Q10 Guideline, published by International Conference for Harmonization (ICH).
Spotlight On Regulatory/Risk Mitigation
Home Thoughts From Abroad: Measurement Of Cognitive Change March and April are traditionally two months that for me involve an unusual amount of business travel. What is different about this year is that the indications under discussion have included depression, schizophrenia, ADHD, Parkinson's disease, Alzheimer's disease, and a variety of other diseases, including hypertension, diabetes, and fibromyalgia.
What Manufacturers Can Do When Hitting The Continuous Improvement Wall Ask manufacturing engineers or production supervisors how long they have been under pressure to reduce costs and improve productivity and they’ll most likely say since they started working. Typically, solving the biggest item first is the order of how issues should be addressed, but what is almost never asked is: "How much variability will be left in our system on the remaining issues?"
Supply Chain Innovations As drugs and therapies become increasingly sophisticated, such scientific innovation creates complex distribution challenges for life sciences manufacturers. Because these advanced treatments are frequently temperature sensitive, they often must be delivered rapidly using technology capable of preserving their efficacy.