SINGLE-USE TECHNOLOGY FEATURED ARTICLES
How Can You Mitigate The Risks Of Single-Use Bags?
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.
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![extractables in single-use]( "Standardized Extractables Testing Advances Single Use Adoption")
Standardized Extractables Testing Advances Single Use AdoptionThe 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.
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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.
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![Mary Lavin]( "WIB Profile: Sponsors And CMOs Require Production Flexibility")
WIB Profile: Sponsors And CMOs Require Production FlexibilityDrug 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
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![Determination Of kLa Values Of Single-Use Bioreactors]( "Determination Of kLa Values Of Single-Use Bioreactors")
Determination Of kLa Values Of Single-Use BioreactorsBecause 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.
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![CelligenBLU]( "Comparing Glass And Single-Use Bioreactors For Growth And Production Of Secreted Proteins")
Comparing Glass And Single-Use Bioreactors For Growth And Production Of Secreted ProteinsThe 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.
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![Comparing Single-Use Bioreactors To Reusable Bioreactors For Production Of Recombinant Proteins]( "Comparing Single-Use Bioreactors To Reusable Bioreactors For Production Of Recombinant Proteins")
Comparing Single-Use Bioreactors To Reusable Bioreactors For Production Of Recombinant ProteinsThe 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.
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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.
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Biological Contamination Events In Isolators: What Lessons Can Be Learned?
Microbiological deviation and biological contamination events have been observed in pharmaceutical isolators including those used in production, sterility test and pharmacy aseptic services. By James Drinkwater, Bioquell UK Process & Compliance Director
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Protein A Alternatives: Mixed Mode Resins For High Throughput mAb Feedstocks
Mixed mode resins can serve as an alternative to protein A in intermediate processing. Implementation of mixed mode resins can reduce water required for filtration and time for column loading.
SINGLE-USE TECHNOLOGY PRODUCTS & SERVICES
The ReadyToProcess WAVE 25 rocker features integrated temperature sensors and load cells, designed for convenient handling and control of cell cultures up to 25 L. A filter heater is delivered with the system.
The CelliGen 510 is a compact sterilizable-in-place cell culture system ideal for pilot to small scale production processes. The modular design features a wide variety of standard options allowing this system to be flexible enough to meet most process requirements.
With the Eppendorf BioSpectrometer basic, measurements can be executed in the UV and Vis range from 200 nm to 830 nm. The freely selectable wavelengths offer you maximum flexibility during these procedures.
The S.U.F. is engineered for optimal oxygen mass transfer, mixing, and temperature control, and performs comparably to traditional stainless steel systems. Using traditional, fundamental engineering principles, scale-up and process development work is streamlined – offering you cost savings and efficiency.
Storage of pharmaceutical compounds is a function of the storage process and not a specific containment driven requirement per se. This is the case whether you are processing in a contained fashion or performing non-contained processing into open kegs with simple drum liners.
ILC Dover brings a unique history and skill set to the biopharmaceutical industry, particularly single use biopharmaceutical powder handling and containment equipment.
SINGLE-USE TECHNOLOGY MEDIA
Bioprocess With The Bozenhardts is back, with a fresh episode packed with advice from Herman and Erich on the selection of filling systems for biopharmas. Listen in as the Bozenhardts give us an update on the process, logistics, and administration trends that are informing filling system decisions today, and offer direction on making choices that will prepare you for the fast-advancing therapies of tomorrow.
Single-use is an inexpensive and flexible way to bring that product into the process, yet the value of that product was low enough that they were willing to take a risk on a new technology.