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News : pharmaceutical, May 2024

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Cherwell Develops Bespoke New Product to Support Air Quality Audit in UCA Operating Theatres

peel-apart packs of Redipor settle plates developed by Cherwell
Air SamplingCleanroomReady-to-use Media
29 May 2024
Cherwell has developed a bespoke product to support a study into air quality in ultra-clean air operating theatres. The new peel-apart settle plates are simply peeled apart aseptically for easy sterile dispensing in an operating theatre setting.

APAS Independence - Quality You Can Count On

APAS Independence
Artifical IntelligenceAutomationColony Counters
29 May 2024
Clever Culture Systems’ APAS Independence® is an innovative platform technology that automates culture-plate screening and interpretation. The system uses artificial intelligence to provide a robust solution for automated plate enumeration.

NEW in 2024! Growth Direct® Rapid Sterility Detection in as Little as 12 Hours

analyst performing sterility test in quality control microbiology laboratory hood
AutomationLIMSSterility Testing
28 May 2024
The Growth Direct® Rapid Sterility System replicates all 3 traditional test conditions within a kit of 3 cassettes. The automated closed-loop system tests as many as 126 kits at once, eliminating risks of human error and secondary contamination, with final results in as little as 1-3 days.

Embrace the Digital Age with Modern Sterility Testing

Sterisart Universal Gen 4
Sterility Testing
28 May 2024
The new Sterisart® Universal Pump | Gen 4 from Sartorius is designed to meet all your quality and safety needs for sterility testing in the modern lab. Watch the product video here.

GMP Compliant Materials and Support for ATMP Manufacturing

GMP Compliant Materials for CGT
ATMP - Advanced Therapeutic Medicinal ProductsCell and Gene TherapiesGood Manufacturing Practice (GMP)
23 May 2024
A comprehensive new resource has been added to the website, where you will find links to all the information you need on how AMSBIO can help you better understand and set up a GMP manufacturing process.

ATP Detection: Overcoming Challenges in Hygiene Monitoring

ATP flow
ATP Testing
21 May 2024
ATP detection offers ways of optimizing cleanliness verification. Explore how ProGnosis Biotech’s ATP FLOW series enhances hygiene monitoring in labs and food industries, ensuring superior cleanliness.

Associates of Cape Cod, Inc. (ACC) Marks 50 Years of Protection Through Detection with a New Look

Image not available
Bacterial Endotoxin Test (BET)EndotoxinLimulus Amebocyte Lysate (LAL)
15 May 2024
Leading biotech company ACC is entering a new era with a brand identity that reflects its dedication to innovation, sustainability, and safeguarding patient safety.

Strengthen Cell & Gene Therapy Production with Smart Quality Testing

QC Quality Control Testing
Cell and Gene Therapies
14 May 2024
Developing Cell and Gene Therapies presents many challenges. Adding rapid and easy-to-use solutions to your operations brings overall efficiencies to the manufacturing process through both simplified workflows and fast, accurate, actionable results to ensure patient safety.

RMM for Cell and Gene Therapies - a rapidmicrobiology Special Focus

Rapid QC Solutions for Cell and Gene Therapies
Special Focus ATMP - Advanced Therapeutic Medicinal ProductsBacterial Endotoxin Test (BET)
14 May 2024
In this rapidmicrobiology special focus we showcase some options for RMM for Cell and Gene Therapy manufacturers, including DNA-free sample collection swabs, bioburden sterility, endotoxin, Mycoplasma, Environmental Monitoring - discover the right products for your process.

AMSBIO Launches GMP-Compliant StemFit™ iPSC Expansion Medium

GMP Compliant Cell Culture Media
ATMP - Advanced Therapeutic Medicinal ProductsCell and Gene TherapiesCell Culture
14 May 2024
Manufacturing and QC are managed in strict accordance with GMP standards, all bottles of StemFit™ Basic04 CT come provided with a certificate of analysis and any documentation required for a seamless transition to clinical applications.

Are You Using the Right Endotoxin Method for Your Samples?

Fujifilm Wako Endotoxin Testing Interview
Expert Insight Bacterial Endotoxin Test (BET)Kinetic Turbidimetric Assay (KTA)
14 May 2024
How do you select and validate the most suitable endotoxin testing method for your particular needs? In this rapidmicrobiology interview, Timothy Francis and Delaney Novak, endotoxin testing Technical Specialists at Fujifilm Wako's LAL division, share their knowledge and expertise.

Rapid ATMP Testing Speeds Up Sterility Release

Scientist performing rapid sterility and mycoplasma testing
ATMP - Advanced Therapeutic Medicinal ProductsMycoplasmaSterility Testing
14 May 2024
Rapid tests for ATMPs cut down sterility & mycoplasma detection times, safely fast-tracking therapies to patients. For a comparison of Microsart® ATMP Bacteria and Microsart® ATMP Fungi Real-time PCR kits with the compendial sterility test, download the application note.

Maximizing Efficiency in Cell and Gene Therapy Manufacturing with BFPC Technology

BAMS technology from Micronview
Air SamplingCell and Gene TherapiesAir Monitoring Real Time
14 May 2024
Explore how BAMS technology revolutionizes cell and gene therapy manufacturing with real-time microbial monitoring, allowing for enhanced sterility and cost savings. Learn about the benefits of BFPCs in ensuring quality and safety standards.

BAMS Elevates Contamination Detection in Cell & Gene Therapy with Real Time Alerts

Cherwell BAMS
Cell and Gene TherapiesEnvironmental MonitoringRoot Cause Analysis
14 May 2024
Discover how BAMS, the real-time biofluorescent particle counter, can transform environmental monitoring with continuous results and instantaneous alerts, aid root cause identification, and expedite clean room validation – all in a portable format.

Microbiological Same-day Results for Cell and Gene Therapy Products

Redberry
ATMP - Advanced Therapeutic Medicinal Products
14 May 2024
Redberry is pleased to announce a significant improvement in the microbiological testing of cell and gene therapy products. Our recent research, conducted jointly with key players in the ATMP domain, has led to a faster detection method that provides same-day results, thus enhancing patient safety.

A Way to Reconcile Early Release of ATMPs and Microbial Safety

Merck reliable rapid bioburden and sterility testing
ATMP - Advanced Therapeutic Medicinal ProductsBioburdenBioluminescence
13 May 2024
A combination of rapid sterility and rapid bioburden testing can increase manufacturer confidence that short-life products, such as cell and gene therapeutics, will be microbiologically safe for release. Both rapid methods can be performed on the same platform after a linked validation procedure.

Improve Your Knowledge of GMP and Annex 1 Regarding ATMPs

Lab workers
ATMP - Advanced Therapeutic Medicinal ProductsEU GMP Annex 1
13 May 2024
In the training Advanced GMP for ATMPS on 2/3 July 2024, you will learn about the existing regulatory requirements for aseptic manufacturing, CCS, data integrity and lyophilization according to Annex 1. Various experts from authorities, industry and consulting will share their knowledge.

Life Science Companies eLabNext and Zifo to Revolutionize Laboratory Digitization

ELabNext and Zifo
Artifical IntelligenceELN - Electronic Lab NotebookLIMS
13 May 2024
Offering state-of-the-art digitization solutions to life sciences laboratories globally, Zifo, a scientific informatics services firm, has teamed with eLabNext, a provider of Digital Lab Platforms to revolutionise laboratory informatics and provide their clients with game-changing results.

Biofortuna Acquires Biological Sample Storage Experts Cryoniss

Sonia Houghton and Dr Nick Ash
Ultra-Low Temperature Storage
13 May 2024
Biofortuna provide genomic services, custom assay development and contract manufacturing solutions to empower their global partners in healthcare, biotechnology and academia to advance innovative life sciences and diagnostic applications in health and wellbeing.

Introducing the Next-generation Sterility Testing Pump for the Connected Lab

Sterisart Universal Gen 4
Sterility Testing
07 May 2024
Designed for the reliable transfer of samples and media into Sterisart® canisters, this new pump meets the stringent quality and safety standards demanded by today's pharmaceutical and biotechnology industries.

A New Solution for Reducing Biologic Interference of Endotoxins

Fujifilm Wako and Predictive Oncology
EndotoxinLimulus Amebocyte Lysate (LAL)
07 May 2024
A new solution exists to improve endotoxin testing of biologic products with EndoPrep™ from Predictive Oncology and PYROSTAR™ ES-F from Fujifilm. Together, the companies have created a powerful opportunity to significantly impact drug safety by enabling more accurate detection of endotoxins.

Ingenza Expands CodABLE® Gene Design Algorithm for Recombinant Protein Production

CodABLE Gene Design Algorithm for Recombinant Proteins
Cell and Gene TherapiesContract Development Manufacturing OrganisationNext Generation Sequencing (NGS)
01 May 2024
Scottish CRDMO Ingenza will adapt its codABLE® machine learning platform for precise control of recombinant protein expression in Pichia pastoris, accelerating the development of therapeutics, enzymes, and other proteins by fine-tuning codon usage and maximizing production yields.

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