Biotech COP E-Letters

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E-Letters were topic-specific, electronic newsletters published four times per year by ISPE's global Communities of Practice (CoPs). The content for E-Letters was submitted by professionals working in the pharmaceutical industry and was a resource by which to share best practices, regulatory news, technical articles and innovative solutions to real world problems. E-Letters were discontinued in 2013.

*CoPs are  an ISPE Member-only benefit; therefore some E-Letter content can be accessed only if you are an ISPE Member. Join ISPE today to continue accessing all E-Letter content and other valuable resources that will assist you in being more effective at your job.

November 2013

Impact of Facility Layout on Developing and Validating Segregation Strategies in the Next Generation of Multi-Product, Multi-Phase Biopharmaceutical Manufacturing Facilities
by Mark F. Witcher, PhD
This article describes how the facility’s layout impacts the process and product segregation strategies required to provide validated separation of products and processes throughout the manufacturing lifecycle. Read more

Biosimilars Development and Supply: How Complex Can the Process Be?
An aging population and those suffering from chronic disease are meeting a new class of biologic medicines.  Biosimiliars are improving competition in Europe and offering additional therapeutic choices to patients and other key stakeholders.  As these new medicines are introduced worldwide, commitment to patient safety mandates regulatory approval standards and ongoing manufacturer accountability. Read more

July 2013

ISPE Biotech Conference Explores Next Generation Manufacturing
Discover how engineers will develop and validate projects using next-generation manufacturing systems, advances in bioprocessing, and streamlined compliance programs. The ISPE Biotechnology Conference (27 – 28 August 2013 in Durham, North Carolina, USA) will feature a plenary session with Nobel Laureate Dr. Oliver Smithies and opportunities to interact with biomanufacturing experts on process development, facility design and integration, compliance and process validation, and many other topics. More.

ISPE Developing Biotechnology Guides
The ISPE Guide: Biopharmaceutical Manufacturing and Process Development will address the development, design, and manufacture of biopharmaceutical products. Its companion, the ISPE Guide: Biopharmaceutical Manufacturing Facilities (Second Edition) will apply to facilities housing the development and manufacture of biopharmaceutical drug substances, also known as Bulk Active Pharmaceutical Ingredients. More. ( 44 KB)

Facility of the Future:  Next Generation Manufacturing Forum
A three-part series in Pharmaceutical Engineering focuses on defining the facility of the future required for manufacturing biopharmaceuticals in the 21st Century:

State-of-the-Art Biotech Projects Among Facility of the Year Award Category Winners
Biogen Idec, MedImmune, Merck & Co., Inc., and Novartis Vaccines and Diagnostics were among those recognized for innovative biotechnology projects in the 2013 Facility of the Year Awards program. More.

July 2010

Applied Process Modeling Today – A Tool for More than Just Capacity Analysis 
The current economic climate, with its reduced capital expenditure and emphasis on sustainability, has dramatically changed industry focus. These factors, in combination with mergers of large pharmaceutical companies, have created a drive to increase production capacity while reducing energy consumption and life cycle costs. Today’s companies need full visibility of facility capacity, limitations, and potential for optimization. This is where Process Modeling finds its new niche environment. Read more.

Design and Optimization of a Large Scale Biopharmaceutical Facility Using Process Simulation and Scheduling Tools 
An article in the March/April 2010 issue of Pharmaceutical Engineering magazine presents a case study focusing on the design and optimization of a large scale biopharmaceutical facility using process simulation and scheduling tools. Read more.

Life-Enhancing Biotherapeutics Company Nets Healthier Equipment 
An article in the March/April 2010 issue of Pharmaceutical Engineering magazine presents a case study showing the impact of an organized and focused continuous improvement effort using teamwork on equipment reliability. Read more.

Method for Implementing Disposables into a Bioprocess Facility
This new ISPE Knowledge Brief presents an implementation model to switch from stainless steel tanks to disposable Bioprocess Containers (BPCs). Read more.

ISPE Washington Conference to Feature Biotechnology-related Seminars and Training
The following biotechnology-related seminars and training will take place at the ISPE Washington Conference, 7-10 June 2010, Washington, D.C., USA:

Pharmaceutical Engineering Magazine Issue to Focus on Biotechnology
The theme of the May/June 2010 issue of Pharmaceutical Engineering magazine is biotechnology. An accompanying, Facility of the Year Awards, special supplement will feature case studies on several biotechnology companies named Category Award winners who are vying for the coveted Overall Facility of the Year Award to be announced at the ISPE Annual Meeting, 7-10 November 2010, Orlando, Florida, USA.

What the Biotechnology Community is Discussing Right Now
Flux rate, vendor qualification, and virus production and roller bottles continue to be hot topics of discussion on the Biotechnology COP site. Read more.

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