Search results for " safety"
Article
Design and Qualification of Single-Use Systems
…e materials of construction and finished component under anticipated use conditions, with reasonable safety factors. These properties can include pressure requirements (e.g., operating, burst, creep,…
Article
Platform Approach Speeds Process Development
Depending on the development goals, different development modules can be selected to best fit the anticipated product quality profiles, safety, process robustness, and scalability. A custom set of mod…
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Selecting the Right Viral Clearance Technology
Remington believes that this increased understanding will facilitate the design of processes that optimize viral safety. Taking a holistic approach is the most effective means of achieving viral contr…
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Aseptic Processing: Keeping it Safe
Concerns related to operator safety exist when dealing with highly potent or cytotoxic drugs, such as is the case with the manufacture of antibody drug conjugates (ADCs) with cytotoxic payloads. To pr…
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Breakthrough Drugs Raise Development and Production Challenges
When the breakthrough program was established as part of the FDA Safety and Innovation Act of 2012, stakeholders envisioned about two to three designations a year. By the end of May 2015, FDA had rece…
Article
Biopharma Advances Demand Specialized Expertise
This helps to reduce the risk to clinical programs and product safety.
Technical/scientific trends
BioPharm: Can you describe productivity improvements your company has experienced from new tec…
Article
Ligand-Binding Assays and the Determination of Biosimilarity
Furthermore, the assays cannot predict the extent of clinical benefit or potential differences in safety, such as those identified risks for the reference product or unidentified risks for the biosimi…
Article
Improving PAT for Biologics
…f these deviations by displaying easy-to-understand graphics, resulting in not only improved health, safety, and environmental (HSE) performance, but also enhanced control and assurance of the overal…
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Viral Clearance Challenges in Bioprocessing
Importance of communication
Meeting regulatory requirements for virus safety depends on well-designed studies that demonstrate virus clearance across multiple orthogonal steps with accurate scale-d…
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Challenges and Trends in Biopharma Facility Design
…l Life Sciences): Regulatory requirements are not changing--assurance of product quality and patient safety remain central, which can create challenges for modular manufacturing designs. Companies ta…