Search results for " compliance"
Article
Modular Manufacturing Platforms for Biologics
On-site construction and compliance teams may need to engage in testing and qualification activities throughout the duration of each project (2).
Pods are required to have a shell building around …
Article
Modern Manufacturing Systems Key to FDA Quality Initiative
OPQ’s lifecycle review initiative and its team approach for integrating quality review and compliance aim to support accelerated review of a growing cadre of breakthrough drugs.
Changes in OPQ’s O…
Article
Securing the Single-Use Supply Chain
…ts must be purchased from a supplier, according to John Briggs, director of quality, regulatory, and compliance at ASI-Life Sciences. As a result, adds Mario Philips, vice-president of single-use tec…
Article
Using Quality by Design to Develop Robust Chromatographic Methods
…measure and the reliability requirements to which the method will be judged so as to produce data in compliance with a minimum quality standard. In other industries, the understanding of data “qualit…
Article
Relationship Building at Top of Mind for Clients
…roduction (1) show, however, it’s no longer enough for CMOs to lay claim to technology, regulatory compliance, and IP protection expertise, as these increasingly become non-negotiable issues.
Spon…
Article
Q&As with Industry Leaders
…t Biologic Drug Development
Steven Lynn, Executive Vice-President, Pharmaceuticals, Regulatory Compliance Associates
Future Downstream Process Development Solutions for…
Article
Monoclonal Antibodies Key to Unlocking the Biosimilars Market
In addition, it is quite expensive to develop more complex biosimilar mAbs, as much as a $200 million investment for one candidate, including the necessary mammalian cell culture facility built in com…
Article
Supplier-Change Management for Drug-Product Manufacturers
…ange in part number
• Change in product documentation (certificate of analysis, certificate of compliance, product drawing, content on the primary container label)
• Change in raw material su…
Article
Flexibility in Biopharmaceutical Manufacturing
Making clinical and commercial batches in the same facility is an additional dimension of flexibility where greater deftness in application of quality policy and compliance is required. Many CMOs have…
Article
The Future of Biopharma
…
• 30% others: product platforms, cost reductions, materials sourcing, supply chain regulatory compliance, biosimilars, etc.
Key Micro-Trends
This relatively evenly distributed breako…