Search results for " drug" in Articles / App Notes
Article
A Diverse Landscape of Patent Issues Seen in the US, UK, and the EU
The complexity and value of these drugs has led to a renewed focus on multiple patenting, in particular the use in Europe of serial divisional applications.
These applications can have a potent…
Article
Innovative Therapies Require Modern Manufacturing Systems
By Jill Wechsler
FDA set a 19-year record in 2015 in approving more new drugs and biologics, and agency officials expect this pace to continue. Manufacturers are testing a full pipeline of importa…
Article
Biopharma Seeks Balance
Peters
A biopharma company answers to multiple masters: the patient who depends on effective drug products for health or survival; regulatory authorities that monitor quality; …
Article
What’s In a Name? For Biosimilars, A Lot
BioPharm International spoke to USP to find out a bit more about how the naming process for a drug occurs and who truly will have the final say when it comes to biosimilar nomenclature.
Naming for…
Article
Framing Biopharma Success in 2016
If the introduction of generic alternatives is a sign of maturity in the biologic-based drug segment, the biopharma companies may want to examine lessons learned by small-molecule based pharma compani…
Article
Managing Biomanufacturing Capacity Expectations
These developments can arise because an opportunity presents itself to improve a drug or add more indications—or, scientific issues may have to be addressed that were not planned. Wyss notes that ther…
Article
mAbs to Watch in 2016
Most of the emerging large-molecule drugs in the asthma pipeline are interleukin inhibitors targeting inflammatory pathways and are indicated for patients who have a reduced sensitivity to corticoster…
Article
Host-Cell Protein Measurement and Control
The amount of residual HCPs in drug product is generally considered a critical quality attribute (CQA), due to their potential to affect product safety and efficacy. Therefore, it is a regulatory requ…
Article
Quality by Design and Extractable and Leachable Testing
Feb 01, 2015
By Anthony Grilli
BioPharm International
Biopharmaceutical packaging performs several vital functions in assuring the drug product safety. First and foremost, packaging must b…
Article
Continuous Manufacturing: A Changing Processing Paradigm
…ceutical companies and contract organizations building or expanding biotechnology facilities to make drugs in innovative ways. BioMarin and Vertex also plan to incorporate elements of continuous proc…