Search results for " drug"
Article
A Look Ahead at BioPharma Manufacturing and Regulation
Regulatory science underpins innovation and practices in drug manufacturing. The most common definition of regulatory science is a discipline that creates new tools, standards, and approaches for use …
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Regulatory Challenges in the QbD Paradigm
The number of blockbuster drugs launched each year has remained relatively constant at 6.5 per year (1). The nearly threefold increase in R&D spending over the past decade has resulted in an increase …
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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…
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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…
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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; …
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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…
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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…
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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…
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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…
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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…