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News : pharmaceutical, Dec 2019

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New Chapter in Ph.Eur for Bacterial Endoxtin Testing by Recombinant Factor C (rFC)

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Bacterial Endotoxin Test (BET)EndotoxinLimulus Amebocyte Lysate (LAL)
17 Dec 2019
Recombinant Factor C, the animal-free alternative in Bacterial Endotoxin to Limulus amebocyte lysate (LAL) has been given a new chapter by the European Pharmacopoeia (Ph. Eur) Commission at its recent 165th session in Strasbourg.

Accurate Surface Monitoring in Isolators

ICR Swab
CleanroomEnvironmental MonitoringIsolator
16 Dec 2019
Isolators and aseptic processing areas, including neoprene gloves, in the pharmaceutical industry need to be regularly monitored to ensure the absence of microorganisms. Discover how to detect low levels of bacterial contamination using ICR swabs. 

Detection of Low Bacterial Load from Neoprene® Gloves with ICR Swabs & Contact Plates

Neoprene Gloves
CleanroomEnvironmental MonitoringIsolator
16 Dec 2019
This study was designed to prove the suitability of ICR Swabs (Ref. No. 146529) and lockable TSA w. LTHThio contact - ICR+ (Ref. No. 146783) contact plates, to detect low numbers of different bacterial test strains from Neoprene® gloves.

Latest Microbiology Newsletter - 10 Dec 2019

latest microbiology product updates
ATP TestingCell and Gene TherapiesHelicobacter pylori
10 Dec 2019
Detect low numbers of different bacterial test strains from Neoprene® gloves, improve data integrity for QC of ATMPs/Cell and Gene Therapies, test for total counts in jams, creams, and fruit preparations, replace CFUs by counting single bacterial cells, detect H. pylori antigen in stool samples.

Cherwell Announces New Microbiology Sales Specialist

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Environmental MonitoringAutomated Media Preparation
10 Dec 2019
Thomas Parkhill has joined Cherwell Laboratories to help drive the companies ambitious growth plans.

Replacing CFU Counts with Single Bacterial Cell Detection

Quantom TX
AutomationBioburdenColony Counters
09 Dec 2019
In less than 30 seconds, the QUANTOM Tx™ scans up to 10 fields of view to produce accurate single bacterial cell counts. The advanced software can account for the varying shapes, sizes, and arrangements of different bacteria.

How Rapid Micro Biosystems Approaches Data Integrity

Rapid Micro Biosystems ALCOA
ATMP - Advanced Therapeutic Medicinal ProductsData Integrity
09 Dec 2019
rapidmicrobiology.com explores with Rapid Micro Biosystems how to improve QC laboratories approach to regulatory and industry expectations for quality control for ATMPs/Cell and Gene Therapies 

SMEs at the Wheel as Labguru Breaks Record

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AutomationLaboratory AutomationLaboratory Management Systems
06 Dec 2019
Biodata has announced a record-breaking third quarter and attribute this to Labguru; their web-based platform electronic notebook that allows laboratories to become more automated for storage and organisation and to design experiments and workflows.

Rapid Microbiological Methods for ATMPs/Gene and Cell Therapies

Rapid Microbiology Testing ATMPs
ATMP - Advanced Therapeutic Medicinal ProductsCell and Gene TherapiesMycoplasma
03 Dec 2019
In this rapidmicrobiology special, we showcase options for rapid testing of biotherapeutics such as ATMPs, gene and cell therapies. Includes risks and international regulations for mycoplasmas, how to get Mycoplasma results in under 1 hour, and the fastest way to get production up and running.

Eliminate Cleanroom Cross-Contamination Risks

Air Sampler
Air SamplingCleanroomEnvironmental Monitoring
03 Dec 2019
Can you be sure that no particles will be carried over inside an instrument if you transfer your instruments between different cleanroom classes? Ensure peace of mind by mounting a HEPA H13 exhaust air particle filter to your MAS-100 NT® sampler.

How Does Your Method of Storing Environmental Sampling Plates Affect Recovery Rates?

Environmental Sampling Plates
CleanroomEnvironmental Monitoring
03 Dec 2019
Environmental monitoring using culture media is generally carried out in cleanrooms and then transferred to an outside lab space for incubation and evaluation of the results. Discover whether pre-storage has effect on microorganism recovery rates.

The Fastest Way to Expand Biotherapeutic Production Capacity 

KUBio and FlexFactory
ATMP - Advanced Therapeutic Medicinal ProductsCell and Gene Therapies
03 Dec 2019
Michelle Stafford, Senior Global Product Marketing Leader, GE Healthcare LifeSciences, talks to rapidmicrobiology.com about how their KUBio prefabricated facilities and FlexFactory platforms are suited for the rapid expansion and growth in the production of biopharmaceuticals.

Quantifying Adeno-Associated Virus (AAV) Aggregation in Gene Therapy Delivery

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Biotherapeutics
02 Dec 2019
Adeno-associated viruses can be used as vehicles for gene therapy, however viral aggregates may cause problems, a new applications study reports on how Asymmetric Flow Field Flow Fractionation coupled with multi-angle light scattering and Ultraviolet detectors can quantify AAV aggregation.

BioFire® Mycoplasma : A Cell and Gene Therapy Game-Changer

BioFire Mycoplasma bioMerieux
ATMP - Advanced Therapeutic Medicinal ProductsMycoplasma
02 Dec 2019
Interview with Dr Sylvanie Cassard of bioMérieux Healthcare, on the new BioFire® Mycoplasma test, an internalised rapid mycoplasma test panel that allows ATMP laboratories to perform mycoplasma tests in-house, requiring no molecular expertise and provides results in under 1hour.

Testing Biotherapeutics for Mycoplasmas - the Risks and International Regulations

Mycoplasma Testing on ATMPs
ATMP - Advanced Therapeutic Medicinal ProductsCell and Gene TherapiesContract Research Organization (CRO)
02 Dec 2019
An in-depth Interview with Helena Windsor of Mycoplasma Experience, the only UK company specialising in Mycoplasmology. Now, in their 4th decade of mycoplasma testing, Helena talks about the fast-moving Cell and Gene therapy market and how mycoplasma testing is vital at this critical juncture.

Managing Microbial Contamination Risk in ATMPs Manufacture  

Cherwell ATMP GMP Services
Air SamplingATMP - Advanced Therapeutic Medicinal ProductsCell and Gene Therapies
02 Dec 2019
Cherwell Laboratories are focusing on where the risk of microbial contamination could occur in ATMPs/Gene and Cellular Therapies and how their products can provide solutions to specific sampling issues.

Partnership Offers UV-C LED Water Disinfection for Laboratory Solutions

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Lab Water
02 Dec 2019
New UV LED disinfection acts as a barrier preventing contamination from entering the laboratory water purification system as a whole, offering a high-level microbial disinfection barrier for laboratory water, directly at the point of use.

A New Automation Solution for the Production and Delivery of Cell and Gene Therapy

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ATMP - Advanced Therapeutic Medicinal ProductsBiotherapeuticsCell and Gene Therapies
02 Dec 2019
Terumo BCT launches first-of-its-kind device to accelerate cell therapy manufacturing

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