Navigation Links
PDA Offers Help in Applying Single-Use Systems to Bio/Pharma Operations
Date:10/16/2014

BETHESDA, Md., Oct. 16, 2014 /PRNewswire-USNewswire/ -- The Parenteral Drug Association (PDA) announces the completion of guidance on the application of single-use, or disposable, systems in the manufacturing operations for pharmaceutical and biopharmaceutical products with the publication of Technical Report No. 66: Application of Single-Use Systems in Pharmaceutical Manufacturing.

Single-use technology, often described as single-use systems (SUS) or single-use equipment, has the potential to transform pharmaceutical manufacturing by offering tremendous opportunities to reduce cost, improve flexibility or cycle time, and shorten the time needed to build a manufacturing process for new, life-saving drugs. This success, however, is very much dependent on how effectively the industry ap­proaches the development and implementation of single-use technology.

PDA Technical Report No. 66: Application of Single-Use Systems in Pharmaceutical Manufacturing is intended to provide the reader with critical concepts or points to consider when implementing an SUS strategy in a pharmaceutical manufacturing process. These concepts are in­tended to be valid both for chemically synthesized small molecules and for bioprocesses that produce large-molecule biopharmaceutical products.

"PDA thanks the task force team of volunteers that produced Technical Report No. 66 for their hard work in ensuring that the document represents the most up-to-date best practices in the application of single-use systems," said PDA President Richard Johnson. "The task force team of authors and contributors was diverse, representing large and small drug manufacturers, vendors to the industry and even the U.S. FDA."

The team of authors was:Robert Repetto, Team Co-Chair, Pfizer

Duncan Low, Ph.D., AmgenMorten Munk, Team Co-Chair, CMC Biologics

Ingrid Markovic, Ph.D., U.S. FDAStephen Brown, Ph.D., BE Vaccines

Jerold Martin, Pall Life SciencesJeffrey Carter, Ph.D., GE Healthcare

Paul Priebe, Sartorius Stedim BiotechNiels Guldager, NNE Pharmaplan

Christopher J. Smalley, Ph.D., Merck & CoChristian Julien, Meissner Filtration Products, Inc.

Russell Wong, Ph.D., Bayer HealthCareContributors to the document were:

Robin Alonso, Genentech

James Robinson, Lachman ConsultantsEberhard Bill, Ph.D., Boehringer Ingelheim

Hillary Russak, GenentechOki Dzivenu, GE Healthcare

Robert Shaw, Finvector—FVT LtdBill Hartzel, Catalent Pharma Solutions

Ken Baker, NewAge Industries Inc.Eric Isberg, ATMI

Sally Kline, Ph.D., AmgenMaik Jornitz, G-Con

Mani Krishnan, EMD MilliporeMichael Kraich, Ph.D., Boehringer Ingelheim

Jessica Frantz, Sartorius Stedim BiotechAbout PDA – Connecting People, Science and Regulation®The Parenteral Drug Association (PDA) is the leading global provider of science, technology and regulatory information and education for the pharmaceutical and biopharmaceutical community. Founded in 1946 as a nonprofit organization, PDA is committed to developing scientifically sound, practical technical information and resources to advance science and regulation through the expertise of its more than 9,500 members worldwide. Go to http://www.pda.org/footer/about-pda to learn more.

Media Inquiries: Walt Morris, 301-656-5900, x. 148; morris@pda.org

Logo - http://photos.prnewswire.com/prnh/20130226/DC66667LOGO


'/>"/>
SOURCE Parenteral Drug Association
Copyright©2014 PR Newswire.
All rights reserved

Related medicine technology :

1. Groundbreaking Legal CBD Delivery System Offers Hope to Thousands Suffering Seizure and Spasm Disorders
2. Burbank Eye Doctor, Ramin Rabbani OD, Now Offers Eyewear Repair Services
3. MedCure Now Offers Perfused Fresh Tissue Models
4. Easy Breathe Now Offers Worlds First "Smart" CPAP Device to Treat Sleep Apnea
5. VHA Inc. Webinar Series Offers Strategies for Transitioning to Value-Based Payment Model
6. Despite Its Limited Size, Chiles Pharmaceutical Market Offers Growing Opportunity for Drug Industry
7. Canada offers essential protective equipment to help stop the spread of Ebola in West Africa
8. Scripps Offers Insights into Nations First All Pencil-Beam Proton Center
9. CVS Health Corporation Announces Final Results of Tender Offers
10. CVS Caremark Corporation Announces Early Results of Tender Offers, Pricing, Election of Early Settlement and Increase in the Maximum Tender Offer Amount
11. El Camino Hospital Offers New FDA-Approved Transcatheter Heart Valve Therapy For Patients Who Are At High Risk To Undergo Open-Heart Surgery
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/10/2020)... ... February 10, 2020 , ... Soter ... and bullying detection and alert system in the world for schools, has announced ... MO-based developer of emergency communications technology for schools, cities, and law enforcement. The ...
(Date:2/10/2020)... ... February 10, 2020 , ... A device that teaches toddlers to go ... a patented sleep training system for children, launching today on Kickstarter. Hush Buddy creates ... Hush Buddy Sleep System, getting a child to sleep soundly is as easy as ...
(Date:2/10/2020)... (PRWEB) , ... February 10, 2020 , ... The Relapsing Polychondritis Foundation is ... British GT driver, will be a Race for RP driver in 2020. ... against relapsing polychondritis (RP) and other autoimmune diseases. , Flewitt has spent the past ...
Breaking Medicine Technology:
(Date:2/13/2020)... ... ... A January 24 article from Refinery29 looks at trends in ... reports on a well-documented dramatic and ongoing increase over the last 20 years in ... knowledgeable and are asking about a number of both traditional plastic surgeries and very ...
(Date:2/11/2020)... LAWRENCEVILLE, N.J. (PRWEB) , ... February 11, 2020 ... ... and medical affairs services and solutions, today announced its move to a new, ... its growing global customer base alongside significant expansion in the development of digital ...
(Date:2/11/2020)... (PRWEB) , ... February 11, 2020 , ... ... dental laboratories across North America, is pleased to announce a $5,000 grant to ... Dental Services Group® (DSG) has generously donated to the Smiles for Everyone ...
(Date:2/10/2020)... ... ... A January 26 article on Live Science reports on why ... – not unlike the skin’s response to dangerous conditions like extreme heat or cold, ... potential damage being done and warn the individual to escape the situation. Pasadena-based dental ...
(Date:2/10/2020)... , ... February 10, 2020 , ... ... vice president in the company’s healthcare division. In this role, Nikki will support ... guide the company’s continued healthcare product development. , “The healthcare industry is ...
Breaking Medicine News(10 mins):