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News : pharmaceutical, Sep 2023

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How to Achieve Pharmacopeia-Compliant Bioburden Testing of Viscous Samples

Pharmacopeia Compliant Bioburden Testing of Viscous Samples
Expert Insight BioburdenMembrane Filtration
26 Sep 2023
Viscous samples place distinct demands on each component of a filtration system. Learn from Sartorius Lab Instruments filtration experts how best to achieve accurate microbiological results for viscous liquids.

Ensuring Pharmaceutical Quality: The Essential Role of Rapid Sterility and Bioburden Testing

The Essentail Role of Rapid Sterility and Bioburden Testing
BioburdenSterility Testing
26 Sep 2023
Rapid sterility and bioburden tests are major components of the pharmaceutical strategy. Unlike traditional methods, rapid sterility testing ensures safe releases, curbing contamination risks and helping to deliver safe, quality treatments to patients.

The Challenge of Implementing Rapid Methods for Bioburden and Sterility Testing

A proven solution for faster sterility and bioburden testing
Expert Insight BioburdenSterility Testing
26 Sep 2023
In this rapidmicrobiology interview Lamin Jallow, Microbiology Technology Specialist for the Life Science business of Merck, discusses the challenges that laboratories encounter when implementing rapid microbiological methods for bioburden and sterility testing.

Incorporating Quality Control Technologies in the Lab

download ebook on implementation of RMMs
Assay Validation
26 Sep 2023
Whilst fully understanding the benefits of alternative and rapid microbiological methods, microbiologists tasked with their implementation can find it hard to know where to begin.  Charles River is there to support with a wealth of resources, including this practical guide, which is free to download.

Puritan® 3 Inch Swabs - Same Quality, Shorter Size!

A small boy measuring his height on a wall chart
SwabsSwabs VirologySwabs with Transport Medium
26 Sep 2023
Puritan can now offer their best-selling 6” handle foam, flock, and spun fiber swabs in 3" handle versions. Ideal for at-home sampling, test kits and more. Connect with Puritan swab experts to discover the right swab for your application.

Improved Viral Vectors Through the Application of Premium 2G UNic™ Technology

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ATMP - Advanced Therapeutic Medicinal ProductsCell and Gene TherapiesContract Development Manufacturing Organisation
26 Sep 2023
Through their combined efforts ProteoNic and NecstGen have achieved up to 5-fold higher functional LV titers, with significant potential impact on overall process efficiency.

Automated Detection System for Early Detection of Microbial Contamination in Filtrable Samples

Milliflex Rapid system for early detection of microbial contamination
ATMP - Advanced Therapeutic Medicinal ProductsATP TestingBioburden
26 Sep 2023
Back by popular demand, the Milliflex® Rapid 2.0 system automatically detects, images, and quantifies viable microbial contaminants in filterable samples throughout the manufacturing process. Delivering results up to 4x faster, it is the ideal solution for sterility and bioburden testing.

Detect Microbial Contaminants Earlier

The Milliflex Rapid 2 system
ATP TestingMembrane Filtration
25 Sep 2023
The Milliflex® Rapid 2.0 system helps to improve process control and product yield while bringing forward end product release. It is compatible with a variety of filterable samples in the pharmaceutical, ATMP, biotech and personal care industries.

Rapid Bioburden and Sterility Testing - a rapidmicrobiology Special Focus

Charles River Sterility testing solutions
Special Focus ATMP - Advanced Therapeutic Medicinal ProductsATP Testing
25 Sep 2023
Faster, easier, compendial compliant - whatever is driving your search for alternative rapid microbiological methods (ARMM) for sterility and bioburden testing in your facility, browse through the latest products here.

Red One™ Rapid Bioburden Testing in 4 Hours, Sterility in 4 Days

Red One Rapid Sterility Testing System
BioburdenSolid Phase CytometrySterility Testing
25 Sep 2023
A fully automated system for rapid detection of microbial contaminations: Red One™ delivers faster results than traditional methods, allowing more rapid confirmation of pharmaceutical product quality and quicker product release.

Reliability in your Microbiological QC for All Biomanufacturing Steps

Condalab Brochure Download
Chromogenic MediaDehydrated Culture MediaMedia Fill Testing
25 Sep 2023
Quality Control in biopharmaceuticals is vital to ensure the quality and safety of a product. Condalab has the required culture media to perform MFT, Sterility Testing, and Non-Sterile Products Testing without complications.

Weighing Solutions for Medical Devices Applications

Cubis II analytical balance
Workflow Optimization
21 Sep 2023
Precision weighing balances for drug eluting stents for accurate, reliable results and increased productivity. Download the Guide to Medical Devices Quality Control and Testing here.

Sterisart® Septum for Reliable Sampling from a Sterility Testing Unit

Sartorius Lab
Sterility Testing
18 Sep 2023
This study assessed the Sterisart® sterility testing device with a septum, for recurrent sterile sample extraction, allowing the coupling with rapid detection methods. Results show that the septum remains intact and the growth media remains sterile even after over 100 repeated sampling events.

Dual-cap Sample Collection Tube for Genetic Testing Workflows

Dual-cap Sample Collection Tube for PCR Testing
PCRSample Collection
18 Sep 2023
Cap2™ is a new 0.2ml PCR microcentrifuge tube featuring a novel dual-cap design with both hinged lid and screw cap to preserve the integrity of samples used in genetic testing workflows. By acting as both a collection and processing tube, sample transfer can be minimized.

Still on the Move - Alternative and Rapid Microbiological Methods

Man in Lab
Event organiser
13 Sep 2023
Demonstrating comparability with the compendial methods, as well as validation, was often more difficult than anticipated, and regulators were often unfamiliar with such changes. Today, more than 15 years later, we are still on the way At the Alternative and Rapid Methods Conference at PharmaLab 2023

Rentschler Biopharma’s UK ATMP Facility Receives MHRA Approval

MHRA Approved Facility UK for ATMP for clinical trials
Adeno-associated virus (AAV)ATMP - Advanced Therapeutic Medicinal ProductsCell and Gene Therapies
13 Sep 2023
Following MHRA approval, Rentschler Biopharma's UK site is now set for clinical production of adeno-associated virus (AAV) vectors for gene therapy, offering a comprehensive range of services from early process and analytical development through cGMP manufacturing for clinical trials.

Expecting More From Your EM Software? Discover Effective Solutions for EM Trending at the 2023 PDA

Reliable and Effective Trend Analysis from your EM Software
21 CFR part 11Data IntegrityData Management
12 Sep 2023
During our participation in the PDA Microbiology Conference, we will collaborate with Vanessa Vasadi Figueroa, who will present an exciting poster delving into various technical discussion points to demonstrate the performance of a specific EM site over time.  

INTERSCIENCE Invests €10 Million in Green R&D Center and Factory

INTERSCIENCE invests in green Factory
Automated Media PreparationColony CountersGravimetric Diluters
11 Sep 2023
INTERSCIENCE invests €10 million in green R&D Center and Factory: 3000 m2 additional surface - Production volumes x 2 - Storage capacity x 2 - Surface area of R&D offices x 2 - 100% energy autonomy - 100% carbon-free energy - 1600 m2 of solar panels - 

Water Quality, A Critical Parameter in Pharma

Condalab Water Quality Control
Lab Water
05 Sep 2023
Water monitoring in Pharma is an essential step to guarantee the quality of pharmaceuticals, and to avoid potential health risks to consumers. Learn more about the water testing required according to Eur. Ph. Download Microbiological Analysis in the Pharmaceutical Industry Brochure.

Unlocking Efficiency and Quality: The Gappscan G2™ Plate Heat Exchanger Testing System

Gappscan G2 Plate Heat Exchanger Testing System
Environmental MonitoringSurface Monitoring
05 Sep 2023
 This innovative plate heat exchanger (PHE) integrity testing system offers a host of benefits, optimizing production processes and ensuring uncompromised product quality.

Pyrostar™ NEO, an Endotoxin Detection Reagent Developed by Recombinant Technology

Pyrostar Neo Synthetic Colorimetric Method
EndotoxinSustainability
05 Sep 2023
The PYROSTAR™ Neo is an extremely sensitive and specific assay for endotoxin detection using a reagent developed by recombinant technology.

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