Search results for " report"
Article
Continued Process Verification for Biopharma Manufacturing
…ently manufactured products or weekly/monthly for frequently manufactured products, with a quarterly report that contributes to the annual product report (APR).
A CPV plan should be regarded as…
Article
HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
Typically, protein samples are submitted, prepared, and analyzed, and then results are reviewed and reported. When developing high throughput or multi-product analytical methods, it is important to ke…
Article
Assessing Manufacturing Process Robustness
…lytical results
annual product quality review outcomes
investigation reports
product recalls
field alert report
product…
Article
Successfully Moving Regulated Data to the Cloud
…data captured in a paper record, electronic systems can be configured to provide automatic alerts or reports to highlight deviations from a defined workflow. This is in addition to the time saving th…
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Biopharma Takes a Nervous Glance Over Its Shoulder
This prediction is the focus of a new report, The U.S. Biopharmaceutical Industry: Perspectives on Future Growth and The Factors That Will Drive It, published by Battelle and the Pharmaceutical Resear…
Article
Drugs, At What Cost?
In a new report, The Global Use of Medicines: Outlook through 2017, IMS Institute for Healthcare Informatics projects that in 2014 total global spending on medicines will, for the first time, exceed $…
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The Importance of Partnering for Bioanalytical Studies
For immunogenicity assays, a statistical report or summary is required to justify your cut point(s). A well-described validation plan detailing the experiments and a priori acceptance criteria should …
Article
Automation Trend in Fill/Finish Reduces Contamination Risk
…ised at the critical, late-stage fill/finish process, according to BioPlan Associates’ 14th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production (2).
The advancemen…
Article
Managing Biomanufacturing Capacity Expectations
According to a report compiled by Patheon, ORC International, and PharmSource, demand and capacity forecast inaccuracies have prompted biopharmaceutical companies to embrace the use of outsourcing wit…
Article
CMOs Continue to Improve Overall Biomanufacturing Performance
Results from BioPlan Associates’ 12th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production (1) offer some clues as to what CMOs are doing to remain competitive.
CMOs…