Search results for " standardization"
Article
FDA Approves First Biosimilar
Mar 06, 2015
By Randi Hernandez
BioPharm International
FDA approved Sandoz’s Zarxio (filgrastim-sndz) on March 6, 2015. The approval is a groundbreaking decision, as Sandoz is the firs…
Article
Quality by Design and Extractable and Leachable Testing
The author discusses the various ways in which a quality-by-design program can enhance the extractable and leachable assessment of a drug product.
Feb 01, 2015
By Anthony Grilli
BioPharm…
Article
Mechanistic Modeling: Does it Have a Future in Process Development?
The application of mechanistic models for process development and optimization has been a topic of discussion in the pharmaceutical industry for many years. Mechanistic models are considered as an a…
Article
Viral Clearance Challenges in Bioprocessing
Challenges remain for virus removal and validation.
Nov 1, 2014
By: Cynthia Challener, PhD
BioPharm International
Volume 11, Issue 27, pp. 42-44
Removal and inactivation of adventitio…
Article
Biopharma Manufacturers Respond to Ebola Crisis
Demand for new therapies and vaccines spotlights production challenges.
Oct 1, 2014
By: Jill Wechsler
BioPharm International
Volume 27, Issue 10, pp. 8-9
The development of new tr…
Article
Continued Process Verification for Biopharma Manufacturing
The authors discuss complications of implementing continued process verification and provide recommended approaches.
Oct 1, 2014
By: Jeff Fleming, Robin Payne
BioPharm International
…
Article
Evaluating Design Margin, Edge of Failure and Process
Design space generation is encouraged in new product development.
Sep 1, 2014
By: Thomas A. Little, PhD
BioPharm International
Volume 27, Issue 9, pp. 46-49
A product’s or proc…
Article
Relationship Building at Top of Mind for Clients
Annual study shows technical expertise is not enough.
Aug 1, 2014
By: Eric Langer
BioPharm International
Volume 27, Issue 8, pp. 12-14
Contract manufacturing organizations (CMOs) shou…
Article
Biopharma Takes a Nervous Glance Over Its Shoulder
Changes are needed to maintain US biopharma innovation leadership.
The US biopharmaceutical industry’s status as the global leader in innovative biopharmaceutical R&D is not guaranteed. Both…
Article
EMA Collaborates with HTA Assessment Networks
High technology assessments are having an impact on biosimilars development in Europe.
Gaining access to Europe’s pharmaceutical markets has become a multi-stage operation. The licensing of a…