Search results for " regulators"

Article Biopharma Says It Has an Evolution in New Technologies and Processes
This week, the Process Development Forum interviews Rita Peters, editorial director of BioPharm International, about Interphex 2018.  At the 2018 Interphex trade show in New York City in April…

Article Manufacturing Standards Key to Advancing Cellular and Gene Therapies
By Jill Wechsler Amid mounting excitement over remarkable efficacy rates for new genetically modified cellular therapies, regulators and manufacturers alike face continuing challeng…

Article Critical Quality Attributes Challenge Biologics Development
The complex nature of biologics adds additional CQAs that must be determined to ensure the safe development of biologics. By Susan Haigney Critical quality attributes (CQAs) are used in biop…

Article Ensuring the Biological Integrity of Raw Materials
By Catherine Shaffer Contamination with microbes, mycoplasma, viruses, and other adventitious agents can be a significant problem in biopharmaceutical manufacturing. Although contamination can o…

Article Biosimilars to Drive Modern Manufacturing Approaches
Reliable, high-quality products require innovative analytics and production. By Jill Wechsler As more biosimilars gain market approval in the United States, and manufacturers launch addition…

Article Microbiological Testing: Time is of the Essence
Pressures to accelerate current and next-gen therapies are challenging traditional microbiological testing methods. By Cynthia A. Challener Effective microbiological testing during biopharmace…

Article 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…

Article A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
Data acquired from osmolality, glucose, and folic acid tests provides useful information for the specific identification of cell-culture media. By Satish Mallya, Benjamin Lay, Lihong McAleer, Alexa…

Article Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
Asking the right questions is crucial to establishing a facility design. By Peter Genest, John Joseph The benefits of adopting single-use technologies in the production of biopharmaceuticals…

Article Cleaning of Dedicated Equipment: Why Validation is Needed
It aims at harmonizing inspection procedures globally by developing common GMP standards, training inspectors, and facilitating exchange of information and mutual confidence between regulators.

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