Search results for " therapeutic" in Articles / App Notes
Article
Biopharma Manufacturers Respond to Ebola Crisis
And Sarepta Therapeutics (Cambridge, MA) is looking to produce clinical supplies of its oligonucleotide (AVI 7537) for initial studies.
A promising treatment is favipiravir (T-705), an oral tablet…
Article
Challenges and Trends in Biopharma Facility Design
…uld become cloneable facility platforms or enter into new production needs, for example for the cell therapeutic and personalized medicine market.
Kranjac (Cytiva): Beyond monoclonal antibodies, …
Article
A Q&A With Dr. Anurag Rathore About the Future of QbD, Part I
Fourth is the extension of the QbD concepts from the traditional process development to analytical development and other key activities associated with the commercialization of biotech therapeutics.
…
Article
Healthcare Reform in China
Chinese healthcare reforms may be a double-edged sword for foreign companies.
Sep 1, 2014
By: Jane Wan
BioPharm International
Volume 27, Issue 9, pp. 8-12
On March 25, 2014, the…
Article
Challenges of Protein Aggregation During Purification
…nces in the affinities, charges, sizes, hydrophobicities, and other physiochemical properties of the therapeutic molecule and impurities, including aggregates. Different combinations of unit operatio…
Article
Applying GMPs to the BioPharma Supply Chain
Patient-centered organization culture
Suppliers need to appreciate the intended use of the medicinal and therapeutic products that their raw materials have been used to produce. They need to under…
Article
Biopharma Moves to Integrated, Single-Use, Downstream Processing
On the smaller scale, Masser also notes that scrutiny by FDA and internal quality control becomes more intense the closer a process step is to the final therapeutic, and as a result there have histori…
Article
Quality by Design—Bridging the Gap between Concept and Implementation
The drive to embed quality-by-design (QbD) principles into the pharmaceutical regulatory framework of the European Union has reached a key point 10 years after the European Medicines Agency (EMA) firs…
Article
The Affordable Care Act's Impact on Innovation in Biopharma
• Invest in targeted therapeutics/personalized medicine based on biomarkers with the goal of drug-diagnostic companions with the ability to demonstrate high value in small subsets of the population.
…
Article
EMA Collaborates with HTA Assessment Networks
…ders (KOLs), mainly comprise appraisals of clinical trial data to ensure that a medicine gives added therapeutic value. But they are also starting to cover types of formulation and manufacturing proc…