Search results for " report" in Articles / App Notes
Article
Technologies and Practices Must Evolve to Meet Demand
The respondents reported that they were involved in many phases of drug development and manufacturing including process development, drug-substance and finished product manufacturing, quality control,…
Article
Impact of Media Components on CQAs of Monoclonal Antibodies
Asparagine concentration has been reported to affect galactosylation level.
Cysteine, along with temperature shift, is believed to reduce protein aggregates and increase their stability in culture …
Article
Establishing Acceptance Criteria for Analytical Methods
Closing the Gap
The % relative standard deviation (RSD)/% CV and % recovery should be report-only and should be included in any evaluation of an analytical method per ICH Q2 (3). Measurements that…
Article
2014 Manufacturing Trends and Outlook
Less than 3% reported a drop in production. Only 8.1% said their companies decreased spending for biopharmaceutical equipment and services in 2013 compared to 2012; 37.8% reported increased spending; …
Article
Trends in Downstream Bioprocessing
And in BioPlan’s recently released 10th Annual Report and Survey of Biopharmaceutical Manufacturing (2), it is found that DSP is one of the top areas in which both industry suppliers and end-users are…
Article
Downstream Processing Continues to Worry CMOs
…bottlenecks don’t appear to show any signs of abating, according to BioPlan Associates 13th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production
(1). In fact, nearl…
Article
Regulatory Challenges in the QbD Paradigm
With respect to product and process changes, the regulation states that each change in product, production process, quality controls, equipment, or facilities must be reported to the agency (16). This…
Article
Biomanufacturing: Demand for Continuous Bioprocessing Increasing
This is up from 68% based on data from our 2016 Annual Report (1).
According to BioPlan’s 17th Annual Report and Survey on Biopharmaceutical Manufacturing Capacity and Production (2), there has…
Article
Efforts Accelerate to Streamline Postapproval Change Process
An International Council for Harmonization (ICH) expert working group (EWG) seeks to define those established conditions (ECs) that affect product quality and thus should be reported to regulatory aut…
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Framing Biopharma Success in 2016
John Jenkins, director of CDER’s Office on New Drugs, reported at the FDA/CMS Summit in December 2015 that manufacturing and inspections—not clinical development—are often the “rate-limited steps” for…