SINGLE-USE TECHNOLOGY FEATURED ARTICLES
The loss of product as a result of bag failure isn’t just an annoyance; it’s an expense, and a costly one at that. However, Chuck Hart, director of manufacturing at Prolong Pharmaceuticals, says with proper fitting and handling, these concerns can be mitigated.
-
Standardized Extractables Testing Advances Single Use Adoption
The Standardized Extractables Testing Protocol For Single-Use Systems In Biomanufacturing written by BPOG members last year establishes a foundation from which to create a standardized approach to extractables testing. However, since its release, there have been some questions and discussions about how to effectively implement the protocol.
-
Single-Use Standardization: Is It Holding Back The Biopharma Industry?
The data from BioPlan Associates’ 12th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production speaks to the industry’s ongoing desires for standardization in single-use devices. As usage of these disposable devices increases, the gap between the importance of standardization and end-users’ satisfaction with their supplier’s standardization efforts has steadily been worsening.
-
WIB Profile: Sponsors And CMOs Require Production Flexibility
Drug manufacturers today are increasingly demanding flexibility in their manufacturing processes. So who better to provide those solutions than someone who has spent her career dealing with change.
SINGLE-USE TECHNOLOGY WHITE PAPERS & CASE STUDIES
-
Determination Of kLa Values Of Single-Use Bioreactors
Because single use bioreactors offered by manufacturers vary in parameters critical for oxygen transfer, they are often not comparable to each other and to conventional glass and stainless steel vessels.
-
Comparing Glass And Single-Use Bioreactors For Growth And Production Of Secreted Proteins
The packed-bed basket technology, developed by New Brunswick Scientific (acquired by Eppendorf Inc. in 2007), provides a shear free environment for production of animal cells. At present, little information is available on the utility of the New Brunswick CelliGen® BLU singleuse bioreactor system for the production of secreted proteins, especially in perfusion mode of operation.
-
Comparing Single-Use Bioreactors To Reusable Bioreactors For Production Of Recombinant Proteins
The objective of this study was to compare Eppendorf BioBLU single-use packed-bed bioreactor vessel and the traditional glass vessel counterpart used in New Brunswick™ CelliGen® 310. Alkaline phosphatase (ALKP)- secreting Chinese Hamster ovary (CHO) cells were used to measure ALKP production in each bioreactor.
-
Effect Of Sterilization On Mechanical Properties Of Silicone Rubbers
Silicone rubber is widely used in the pharmaceutical industry where sterilizability is an essential requirement for all fluid transfer equipment. Pharmaceutical products must be sterilized frequently and repeatedly by high level energy and/or chemical vapor in order to eliminate bacterial surface contamination.
-
Meeting BioPharma Needs For Lower Operating Cost And Faster Time To Market
Broad adoption awaits fully scalable GMP systems, improved and less costly disposables, better analytics, greater process automation and low-shear mixing.
-
The Next Bioprocessing Revolution: Functional Additives
Now that many bioproduction technologies and processes are reaching maturity, manufacturers are seeking out the next level of refinements. As an extension of successful fed-batch strategies (such as the use of matched media and feeds), the next stage in bioprocess refinement involves the development of highly concentrated functional additives that can be added to each bioreactor run in the smallest amount necessary to give good titer increases.