Search results for " regulations"
Article
Defining Risk Assessment of Aseptic Processes
The concepts set forth in the FDA guideline are also set forth in the European regulations (2).
High-risk areas to assess
One of the most critical areas for establishing your risk assessment i…
Article
Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
Code of Federal Regulations, Title 9, Animals and Animal Products (US Government Printing Office, Washington, DC) Part 113.53, pp. 700-701 (2012) “Requirements for ingredients of animal origin used fo…
Article
A Q&A with Eric Langer: CMOs Embrace New Technology
Process Development Forum speaks with Eric Langer, President and Managing Partner at BioPlan Associates, and the author of a number of biopharma studies, about the 2016 13th Annual Report and Survey…
Article
Reporting Quality Metrics to FDA
What do you recommend?
A: As with all regulations or guidance documents, there can be various approaches to achieving compliance. Quality metrics need to be specific to each business and circumsta…
Article
Vaccine Development Faces Urgency and Challenges
Despite the proven effectiveness and value of vaccines, health agencies and insurers want lower prices, while conflicting regulations add to manufacturing costs.
For example, the transfer of produ…
Article
Innovative Therapies Require Modern Manufacturing Systems
FDA and industry see progress and challenges in bringing cutting-edge medicines to patients.
By Jill Wechsler
FDA set a 19-year record in 2015 in approving more new drugs and biologics, and …
Article
CMOs Concerned With Cost of Single-Use Equipment
Suppliers indicate prices for single-use equipment are likely to increase.
By Eric Langer
Contract manufacturing organizations (CMOs) have been enthusiastic adopters of single-use technologi…
Article
Advanced Technologies Facilitate Scale-up and Technology Transfer
Single-use and modular technologies plus continuous manufacturing are increasingly important to biopharma scale-up and tech transfer.
Jun 01, 2015
By Cynthia A. Challener
BioPharm Inte…
Article
Biomanufacturing Outsourcing Globalization Continues
May 02, 2015
By Eric S. Langer
BioPharm International
Volume 28, Issue 5
Biopharmaceutical manufacturing clusters continue to emerge outside of the traditional hubs of North America …
Article
Use of Multivariate Data Analysis in Bioprocessing
Apr 06, 2015
By Anurag S. Rathore, Sumit K. Singh
BioPharm International
The ever increasing demand of biotherapeutics, together with the pressure to contain healthcare costs have motiva…