Search results for " safety" in Articles / App Notes
Article
Brazil Emerges as Global Biopharm Collaborator
Brazil is also controlling the efficacy and safety of pharmaceutical products through market regulation.
According to Guimarães, considering government expenditures with health products, biophar…
Article
Predicting Progress in Protein Aggregation
If aggregation occurs during formulation, which is of particular concern for protein-based products that require high concentration, the performance and safety of the product can be affected. “There i…
Article
Best Practices in Adopting Single-Use Systems
Vendors have taken on the burden of documenting their products’ suitability and safety, which had previously fallen to a large extent on end-users. Moreover, the 5- to 10-fold improvement in product t…
Article
Climate Change in Outsourcing
…of-of-concept (POC) model, which calls for minimizing development efforts until there is evidence of safety and efficacy in human subjects. POC is leading to specialization in the CMC (chemistry, man…
Article
Biotechnology Innovation and Growth in Israel
Key regulatory considerations
New drugs registered in Israel, including biologics, must meet European Union (EU) standard GMPs in terms of quality and efficacy to ensure public safety. In ad…
Article
Supplier-Change Management for Drug-Product Manufacturers
Additional Concerns for Critical Suppliers
For materials or services with a high potential to affect product quality and/or patient safety, a more formal and detailed contract may be required to d…
Article
Essentials in Establishing and Using Design Space
Tolerance design can be done either with statistical distributions (when low risk and no safety issues) and/or with transfer functions (how X influences Y). Establishing a design space allows for the …
Article
Prescribing Caution for Biosimilars
We welcome the opportunity to further discuss this issue with lawmakers as they seek to address vital drug safety measures that accompany this cutting-edge technology.
James C. Greenwood, Presiden…
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The Development and Application of a Monoclonal Antibody Purification Platform
In these cases, there were occasional issues surrounding virus clearance, raising safety concerns especially for antibodies required in large doses. To address these issues and increase the robustness…
Article
HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
Robotic liquid samplers can increase reproducibility, efficiency, and safety compared to manual handling of samples.
The final steps to most characterization workflows include data analysis and…