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News : pharmaceutical, Oct 2019

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Modular Bioprocessing Units Go Viral

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ATMP - Advanced Therapeutic Medicinal ProductsGene and Cell Therapies
29 Oct 2019
GE Healthcare have designed new KUBio bioprocessing modular units for the high demand in viral vectors to be used in the growing cell and gene based therapy market.

BREXIT, We’re Ready to Go - Are You?

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Sample CollectionSpecimen TransportSwabs
29 Oct 2019
For continuity of supply as BREXIT looms choose TSC for high-quality microbiological consumables that you can be confident in whatever your compliance needs.

Cherwell Highlights New ImpactAir ISO-90 Microbial Air Sampler at Pharmig

Air Monitor EU GMP Annex 1 revision
Air Sampling IsolatorsEnvironmental MonitoringGood Manufacturing Practice (GMP)
29 Oct 2019
Designed to integrate into isolators or RABS, the new ImpactAir® ISO-90 Monitoring Platform addresses continuous air monitoring as per EU GMP Annex 1 revision.

INTEGRA Offers a Clear Advantage™ for NGS Library Preparation

Dual Reservoir
Liquid HandlingMultichannel PipettesSample Preparation
21 Oct 2019
INTEGRA’s Clear Advantage™ reagent reservoir portfolio saves money and space by using disposable inserts that fit into reusable bases, and the 10, 25 and 100 ml multichannel reagent reservoirs are now available with their innovative SureFlo™ system to minimize dead volumes.

Honeyman Group Expands Production of Revolutionary High Purity Water Systems

Honeyman High Purity Water Systems
21 Oct 2019

Pharmaceutical water specialists, Honeyman Group, expand manufacturing facilities in the North East committing to a £1 million investment over 3 years.

Compare Baker Ruskinn Bugbox to Anaerobic Jars – True Cost Calculator! 

Baker Ruskinn Bugbox
Anaerobic/Microaerophilic EnvironmentsAnaerobiosisCampylobacter
21 Oct 2019
Looking at ways to increase productivity?  The Bugbox calculator works out the true costs in materials and labor for Anaerobic or Microaerophilic Jars/Packs and compares it to the costs of buying and running a Baker Ruskinn incubated anaerobic or microaerophilic workstation. Compare today! 
 

How To Get Rapid Results from Traditional Microbiology Methods

Real-time Colony Counter
Chromogenic MediaColiformsColony Counters
18 Oct 2019
The INTERSCIENCE ScanStation is a smart real-time colony counter, providing rapid results from traditional agar plates including chromogenic media allowing recording of visual growth data for full traceability and data integrity.

FDA-Cleared Liofilchem MTS™ (MIC Test Strip) Imipenem-Relebactam (I/R) 

MIC Test Strip
Antibiotic SensitivityMIC (Minimum Inhibitory Concentration
15 Oct 2019
Liofilchem has received clearance from the FDA to market in the United States the Imipenem-relebactam 0.002/4-32/4 MTS™ (MIC Test Strip), a quantitative assay for determining the Minimum Inhibitory Concentration (MIC) of Imipenem-relebactam.

Ensuring Data Integrity Using PDA TR80 and ALCOA/ALCOA+

Infographic
Data IntegrityGood Manufacturing Practice (GMP)
14 Oct 2019
Rapid Micro Biosystems breaks down how to successfully use the TR80 framework and ALCOA/ALCOA+ that helps to support the FDA’s agency stated efforts to improve drug quality through vigilant oversight of data integrity and good manufacturing practice. 

Procarta Receives $9.2 million in Fight Against ESKAPE Pathogens

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Antimicrobial Resistance (AMR)ESKAPE Pathogens
10 Oct 2019
A platform of novel oligonucleotide-based antimicrobials expected to be highly efficient against the most prevalent nosocomial pathogens receives further funding.

Roche cobas Babesia Granted Approval by FDA

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Babesia
10 Oct 2019
Roche cobas Babesia has been granted approval by the FDA for its fully automated molecular test for the most frequently reported transfusion-transmitted parasitic infection in the U.S

What's on Show at the PDA Conference on Pharmaceutical Microbiology 2019

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Bacterial Endotoxin Test (BET)BioburdenData Integrity
08 Oct 2019
Browse through the latest products on show at this years PDA Microbiology exhibition - includes updates on Mycoplasma testing, endotoxin and pyrogen testing, data integrity, GPT organisms.

One-hour Mycoplasma Testing by Anyone, Anywhere, Anytime.

BIOFIRE MYCOPLASMA
Mycoplasma
08 Oct 2019
Do you think Fast, Easy and Accurate Mycoplasma testing is a fantasy? It's not. bioMérieux has simplified complexity with the BIOFIRE® Mycoplasma “Lab in a Pouch”.

Time-tested Quality with MilliporeSigma.  What’s New at Booth 313?

Pyrogen Detection Kit
BioburdenMembrane FiltrationPyrogen
08 Oct 2019
Come visit MilliporeSigma at PDA Micro Booth #313 and be the first to see the latest improvements in your daily testing workflows. 

Still Using Paper to Manage Your QC Data?

MODA-EM
Data IntegrityLaboratory Management Systems
08 Oct 2019
Replace paper with productivity - the MODA™ Platform bridges the gap that currently exists between manufacturing and QC to provide a single batch record with an intuitive review and approval interface.  The MODA™ Platform has GMP compliance and tracking at its core.

How to Ensure your Data Integrity with ScanStation, Real-time Bacterial Monitoring

ScanStation
Data IntegrityIncubators
08 Oct 2019
ScanStation, real-time bacterial monitoring unit, detects and counts colonies as soon as they appear at the beginning of the incubation.  It provides anticipated results for quality control labs with full data integrity 21 CFR part 11.

Let’s Explore Endotoxin Testing Solutions at PDA Microbiology 2019

What are the options for Endotoxins Testing
EndotoxinMonocyte Activation TestPyrogen
08 Oct 2019
Speak with Lonza Experts about your endotoxin testing challenges at Booth #310. Let’s solve them together. Additionally, see our poster presentation “Establishing the Monocyte Activation Test (MAT) in a New Lab - Assay qualification and product-specific validation.
 

Source Bioscience Meet Demand with Investment in Ireland

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Contract Service LaboratoryMicrobial Limit TestingSterility Testing
08 Oct 2019
Source BioScience have invested €585,000 in a new microbiology and sterility testing lab at Tramore along with an increased storage capacity planned for the future giving customers faster turnaround times on results and cutting distribution costs. 

Explore Charles River Microbial Solutions at PDA Microbiology 2019

Complete Microbial Solutions from Charles River
ATP TestingBacterial Endotoxin Test (BET)Data Integrity
08 Oct 2019
Find out why you should visit Charles River Booth #209 at this years PDA Global Conference on Pharmaceutical Microbiology

Controls You Can Rely On

GPT Plate
BioburdenEnvironmental MonitoringGrowth Promotion Testing
08 Oct 2019
Meet USP requirements with test-ready microbial controls for Growth Promotion Testing and Environmental Monitoring controls.

Microbiologics Acquires Michigan-Based Microbiology Laboratory Micromyx

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Contract Research Organization (CRO)
08 Oct 2019
The biomaterials leader will leverage Micromyx’s unique R&D and regulatory expertise to better serve customers

Pharmig's Rapid Method Validation and Implementation Training with Dr Michael J Miller

Training on RMM Validation - Pharmig
07 Oct 2019
As part of Pharmig’s focus on continuous development of professionals working in the field of microbiology in the pharma and biopharma industry, members were given the opportunity to be trained in the validation of rapid microbiological method technology by world expert Dr Michael J Miller. 

Ask a CAP Inspector: How Frequently Should Molecular Targets be Rotated?

Microbiologics reliable test ready control panels
QC Molecular Standards
04 Oct 2019
There’s no one-size-fits-all approach for determining when to QC molecular multiplex assays or for choosing which targets to test. Follow these best practices from experienced CAP auditor, Joslyn Pribble, to create a QC plan that’s right for your lab.

Pipette Tips Deliver Superior Liquid Handling and Dispensing

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Liquid Handling
01 Oct 2019
Block out aerosol and liquid contaminants with Porvair Sciences new range of Liquid Handling Pipette Tip Filters, fully compliant with FDA, USP Class VI and European Pharmacopoeia statutory regulations as well as being free from heavy metals.  

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Pyrostar Neo Article
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MAS 100 Libra passive air monitoring now automated
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INTEGRA expert insights on the innovations advancing serological pipetting
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Validation QC Standards Proifiency Testing
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