Microbiology News: Pharmaceutical

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Microbiology News: Pharmaceutical

Assay Development Clinical Cosmetic/Personal Care Food & Beverage Laboratory Equipment Microbiome Other Pharmaceutical Veterinary Water

Weighing Solutions for Medical Devices Applications

21 Sep 2023 | Pharmaceutical

Precision weighing balances for drug eluting stents for accurate, reliable results and increased productivity more...

Reliability in your Microbiological QC for All Biomanufacturing Steps

21 Sep 2023 | Pharmaceutical

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. more...

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

21 Sep 2023 | PharmaceuticalCosmetic/Personal Care

Milliflex Rapid system for early detection of microbial contamination

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. more...

The Challenge of Implementing Rapid Methods for Bioburden and Sterility Testing

20 Sep 2023 | Pharmaceutical

A proven solution for faster sterility and bioburden testing

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. more...

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

19 Sep 2023 | Pharmaceutical

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. more...

Sterisart^® Septum for Reliable Sampling from a Sterility Testing Unit

18 Sep 2023 | Laboratory EquipmentOtherPharmaceuticalMicrobiome

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. more...

Dual-cap Sample Collection Tube for Genetic Testing Workflows

18 Sep 2023 | Food & BeverageWaterClinicalPharmaceuticalMicrobiomeAssay Development

Dual-cap Sample Collection Tube for PCR Testing

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. more...

Still on the Move - Alternative and Rapid Microbiological Methods

13 Sep 2023 | Pharmaceutical

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 more...

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

13 Sep 2023 | Pharmaceutical

The Essentail Role of Rapid Sterility and Bioburden Testing

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. more...

Rentschler Biopharma’s UK ATMP Facility Receives MHRA Approval

13 Sep 2023 | Pharmaceutical

MHRA Approved Facility UK for ATMP for clinical trials

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. more...

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

12 Sep 2023 | Laboratory EquipmentPharmaceuticalVeterinary

Reliable and Effective Trend Analysis from your EM Software

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. more...

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

11 Sep 2023 | Food & BeverageWaterLaboratory EquipmentPharmaceuticalVeterinaryCosmetic/Personal Care

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 - more...

How to Achieve Pharmacopeia-Compliant Bioburden Testing of Viscous Samples

06 Sep 2023 | Pharmaceutical

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. more...

Water Quality, A Critical Parameter in Pharma

05 Sep 2023 | Pharmaceutical

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. more...

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

05 Sep 2023 | Food & BeveragePharmaceutical

This innovative plate heat exchanger (PHE) integrity testing system offers a host of benefits, optimizing production processes and ensuring uncompromised product quality. more...

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

05 Sep 2023 | Pharmaceutical

Pyrostar Neo Synthetic Colorimetric Method

The PYROSTAR™ Neo is an extremely sensitive and specific assay for endotoxin detection using a reagent developed by recombinant technology. more...

Slaughter Free FBS Replacement Now Available for B2B Sales

31 Aug 2023 | Laboratory EquipmentPharmaceuticalAssay Development

Plenty, a bovine platelet lysate is an ethical replacement for Fetal Bovine Serum (FBS) that is equally effective but available for a fraction of the cost. a culture supplement filled with growth factors and cytokines for regenerative medicine, cell culture, and vaccine production. more...

Data Integrity as an Indicator of Other Quality Control Issues

28 Aug 2023 | Pharmaceutical

Due to numerous and severe regulatory findings, companies have all boarded the data integrity train and started remediating their automated systems, developing checklists, process flowcharts, and risk registers. But what if data integrity is not the real problem, but a result of another issue? more...

Detect Microbial Contaminants Earlier

28 Aug 2023 | PharmaceuticalCosmetic/Personal Care

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. more...

Fast Filtration of Oily and Viscous Samples by Dilution in Isopropyl Myristate (IPM) - Download Here

22 Aug 2023 | PharmaceuticalMicrobiome

Detecting microorganisms in liquids is important for quality control in biotech and pharmaceuticals. Membrane filtration is preferred, but viscous substances pose challenges. Discover how diluting with isopropyl myristate allows for high throughput of viscous samples. more...

Cherwell to Advise on Reducing Risk with EM in Aseptic Processing

22 Aug 2023 | Pharmaceutical

Cherwell’s microbial EM experts will be present at a number of aseptic processing focused events to discuss and highlight best practice and product solutions for differing EM needs to ensure the safety and quality of sterile medicinal products. more...

Preparing for an Audit with Environmental Monitoring Processes

21 Aug 2023 | Pharmaceutical

The updates to Annex 1 will be enforced from 25 Aug 23. Revisions focus on minimizing risk with added CCS measures which outline how QRM will be applied. Continuous EM is highly emphasized in this revision as a means for identifying and controlling microbial risk. Are you prepared for your next audit? more...

Refeyn Expands into AAV-based Gene Therapy Manufacturing with GMP Software

16 Aug 2023 | ClinicalPharmaceutical

Refeyn has launched its new software package for GMP to augment the application of the Samux^MP and Samux^MP Auto mass photometers within AAV-based gene therapy manufacturing facilities. more...

Lonza Launches Nebula^® Absorbance Reader for Streamlined Endotoxin and Pyrogen Testing

15 Aug 2023 | Pharmaceutical

The new Lonza Nebula® Absorbance Reader provides QC labs with a fully optimized absorbance reader, with high-performance optics and monochromator-based wavelength selection to ensure precise and accurate measurements of endotoxin levels, and reduces the risk of false positives or negatives. more...

Unraveling the Past: Tracing the History of DNA Sequencing

08 Aug 2023 | ClinicalPharmaceutical

DNA Sequencing: 13 years to 6 hours - A journey through history. From foundational discoveries in the 19^th century to today's rapid advancements, revolutionizing genomics.  more...

Download the Rapid Biosimilar Downstream Processing Assessment

25 Jul 2023 | Pharmaceutical

Learn how a high-throughput single analyte concentration screen is used to assess binding kinetic and affinities (ka, kd, KD) from column elution fractions to aid the selection of biosimilars under development. Download the application note here. more...

Secure Compliance by Choosing 3P^® CONNECT SOFTWARE for Environmental Monitoring

25 Jul 2023 | Pharmaceutical

Thanks to the implementation of a Secure Development Lifecycle and the support of bioMérieux’s experts and partners, cybersecurity is integrated in the design of 3P^® CONNECT, a solution to secure the traceability and collection of your EM data. more...

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