Search results for " pharmaceutical"
Article
Labeling of Biosimilars
Regulatory issues
Nonetheless, there are a number of regulatory issues with biosimilars that parts of the pharmaceutical industry believe still need to be sorted out by EMA. The biggest of these is…
Article
Monoclonal Antibodies Key to Unlocking the Biosimilars Market
mAbs are also extremely costly, and biologic versions are needed to maintain functioning healthcare systems, according to Theodor Dingermann, a professor and director of the Department of Pharmaceutic…
Article
Early Communication with Regulators is Essential for SMEs
Among the EU’s regulatory agencies in pharmaceuticals, the most active in championing innovation has been the European Medicines Agency (EMA), which is responsible for centralized approvals of medicin…
Article
State of Quality and Compliance in the Biopharmaceutical Industry
Among these initiatives are the Pharmaceutical cGMPs for the 21st Century, process analytical technology (PAT), quality by design (QbD), and harmonization of international standards and guidelines.
…
Article
Regulatory Requirements for Safe and Efficient Biologic Drug Development
Looking at various International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use Q10, Q9, Q8, going back into the pharmaceutical development, it depends on where …
Article
Addressing the Complex Nature of Downstream Processing with QbD
These steps combine to build quality into pharmaceutical processes and products over the lifecycle of a pharmaceutical product.
The industry has been slowly adopting the QbD approach, but with the…
Article
Nurturing Knowledge from Disparate Data Streams
Leveraging vast quantities of analytical data requires digitalization and platform integration.
By Cynthia A. Challener
jijomathai/stock.Adobe.comAnalytical instrument…
Article
Biopharma Seeks Balance
Big Pharma spinoffs, startups, virtual companies, industry-academia partnerships, and a growing contract services market contribute to the changing landscape of the pharmaceutical industry.
Glo…
Article
Roadmap Leads to Innovative Biomanufacturing Strategies
…ndependent consultant who previously served as director of cell culture process development at Shire Pharmaceuticals.
Different perspectives
BioPharm: Why is it important to have the different…
Article
Evaluating Surface Cleanliness Using a Risk-Based Approach
The preferred materials of construction in the pharmaceutical industry are 304 and 316L stainless steel. Other materials of construction are used throughout the industry. The selection of materials sh…