Search results for " report" in Articles / App Notes
Article
Quality Systems Key to Lifecycle Drug Management
Industry seeks a “do-and-tell” approach that permits companies to make changes and then list them in annual reports or in changes-being-effected (CBE) supplements. FDA issued a guidance in March 2014 …
Article
Vaccine Development and Production Challenges Manufacturers
Even though measles was declared eliminated in the United States in 2000, CDC reported nearly 650 cases of measles in 27 states in 2014. The disease now has spread to multiple communities, as vaccine …
Article
Outsourcing Trends in Biopharmaceutical Manufacturing
According to BioPlan Associates’ 10th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production (1), outsourcing and off-shoring have migrated into much more high-value areas…
Article
Bioprocessing Advances in Vaccine Manufacture
Significant improvements are now commonly being reported as companies develop, adopt, and adapt bioprocessing technologies to vaccine manufacture.
Single-Use Adoption
BioPlan's 10t…
Article
Virus-like Particles as Therapeutic Moieties of the Future
An IVRP assay reports the qualitative and quantitative epitope composition of a VLP sample and is a good predictor of VLP potency. The results of the assay have been found to correlate well with human…
Article
Using Multiple Techniques in Biosimilar Analysis
While these two techniques are orthogonal, they are also complementary in that they are biased counter to one another: CD is biased toward reporting on α-helical content; and FTIR is biased toward rep…
Article
Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
Only aggregate levels are reported here because low-molecular weight species were unchanged in all conditions. Based on the qualified intermediate precision of the method, changes in percent aggregate…
Article
A Q&A on Bioprocessing Trends and Technologies at INTERPHEX 2016
Complexity and scale are two stumbling blocks to the implementation of single-use systems on the commercial manufacturing scale, reported participants in a panel discussion hosted by BioPharm Internat…
Article
Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
…ersion of the FMEA tool, similar to what is published in Parenteral Drug Association (PDA) Technical Report (TR) 44 and PDA TR 54 (for biopharmaceuticals) (3, 4). An FMEA is appropriate for managing …
Article
Finding Opportunities in Brazil
Growth in 2014 was expected to be around 13%, IMS Health reported. The final growth figure for 2014 had not been released before the publication of this article.
According to the Brazilian Pharmac…