Evolving Technologies, Regulations and Processes in Biotechnology
Publishes: 20 January 2014
The January/February issue of Pharmaceutical Engineering will feature a cover story on the application and implementation of quality by design on vaccines developed from a discussion at an ISPE Biotech Conference. This issue will also feature a lead article on the 2013 Facility of the Year Winner, Novartis, with a look at their US Flu Cell Culture Facility in Holly Springs, North Carolina. Other articles in this issue will explore environmental controls within the biopharmaceutical and medical device industry; cloud computing in a GxP environment; temperature management of non-refrigerated clinical supplies; the application of single-use equipment for storage and distribution; a comparison of regulations governing dietary supplements; harmonization approaches for compliant laboratory computerized systems; e-beam sterilization approaches; and the blinding of materials in clinical trials for ensuring data integrity.
Call for Articles
Pharmaceutical Engineering is looking for subject matter experts in the global pharmaceutical industry with knowledge of the latest scientific and technical developments, regulatory initiatives, and innovative solutions to real life problems and challenges who can contribute application articles and case studies.
Special features and guest editorials will be considered that focus on new technology, contemporary quality management practices, and production innovation.
New Departments include: facilities and equipment, information systems, product development, production systems, quality systems, research and development, supply chain management, and regulatory compliance.
23 August 2013 is the deadline to submit an article for the January/February 2014 issue. For more information, please visit the "Submit Article" page.
What topics would you like to read or write about in Pharmaceutical Engineering?
Email Gloria Hall: firstname.lastname@example.org
Cover Story/Lead Article: Sustainability and Green Manufacturing
|Manuscripts Due: 6 May 2013||Publishes: 18 Sep 2013|
|Specific topics could include: LEEDs, packaging considerations, paperless documentation, waste management, carbon footprint offsets and reductions, energy audits, airborne emissions, best practices, and case studies by site/by company.|
Cover Story/Lead Article: Cleaning, Sanitization, and Sterilization
|Manuscripts Due: 5 July 2013||Publishes: 13 Nov 2013|
|Specific topics could include: alternatives to SIP, CIP, autoclaves, single-use technologies, ozone, case study on Sterile revision, regulatory summary onUS FDA vs. EU approach to sterile processing (example: room classification, autoclaves),and different regulatory approaches based on US vs. EU manufacturing.|
Cover Story/Lead Article: Evolving Technologies, Regulations, and Processes in Biotechnology
|Manuscripts Due: 23 August 2013||Publishes: 20 January 2014|
Cover Story/Lead Article: Trends in Pharmaceutical Quality Management
|31 October 2013||Publishes: 24 March 2014|
Cover Story/ Lead Article: Complexity and Risk in the Global Supply Chain
|Manuscripts Due: 8 January 2014||Publishes: 26 May 2014|
Cover Story/Lead Article: Next Generation Manufacturing
|Manuscripts Due: 6 March 2014||Publishes: 21 July 2014|
Cover Story/Lead Article: Quality Metrics in Pharmaceutical Manufacturing
|Manuscripts Due: 8 May 2014||Publishes: 22 Sep 2014|
Cover Story/Lead Article: Risk Management Strategies when Outsourcing
|Manuscripts Due: 9 July 2014||Publishes: 24 Nov 2014|