Search results for " event"
Article
Application of Quality by Design to Viral Safety
Using this approach, products are developed with a thorough understanding of how the raw materials and manufacturing processes impact the eventual clinical performance of the final drug product. QbD f…
Article
A Q&A With Phil Lester, co-organizer of the HTPD Conference
In fact, the conversations at each event have a significant impact shaping the agenda for the following conference. It’s really building a community around an emerging technology. We’re all willing to…
Article
Novel Vaccine Technologies Meet the Need for Pandemic and Therapeutic Solutions
Cell-culture technology
Cell-culture technology enables the use of raw materials that are readily available and not threatened by pandemic events, as well as closed-system bioreactors that reduc…
Article
Q&A with Industry Leader Konstantin Konstantinov, Genzyme Vice-President
Can you talk to us about the state of continuous processing in biotechnology?
A: Yes, the event is the International Symposium on Continuous Manufacturing of Pharmaceuticals (May 20-21, 2014…
Article
Best Practices in Adopting Single-Use Systems
Customers should inquire about a vendor’s contingency plan in the event of a supply interruption.
Frequent change notices from single-use system suppliers altering materials of construction …
Article
Climate Change in Outsourcing
As 2013 draws to a close, the bio/pharmaceutical industry continues to be reshaped by changes in the business climate. Financial, political, and scientific developments that began 10 years ago conti…
Article
State of Quality and Compliance in the Biopharmaceutical Industry
It might take time to happen, but a process that is not designed appropriately to mitigate quality risks will almost certainly experience a major quality event in the future. When a quality failure ha…
Article
Operational Excellence: More Than Just Process Improvement
The reports were then designed to connect the event and its root cause to the corrective and preventive action (CAPA), helping make recurring deviations rare.
In a parallel effort, batch records we…
Article
Welcome to the new Process Development Forum
…Process Development
Each category features a comprehensive collection of articles, news, and events, as well as top picks of content in that area.
Other new features include:
• A …
Article
QbD and PAT in Upstream and Downstream Processing
CQAs usually include properties that affect product quality and eventually overall performance of the bioprocess. CQAs are typically also release tests, although they don't have to be as there are no …