video
Video: Single versus multilayer film in cold chain bioprocessing
Our video highlights how Aramus™ bag assemblies overcome single-use bag failures at cold temperatures with a new single-layer fluoropolymer material.
List view / Grid view
Gene therapy
news
Gates Foundation to fund Novartis’ development of a sickle cell disease gene therapy
The Gates Foundation will fund Novartis’ discovery and development of a gene therapy for sickle cell disease that is accessible for low- and middle-income countries.
news
Marketing of Zynteglo suspended as precaution due to potential cancer risk
bluebird bio has chosen to suspend sales of Zynteglo while they investigate whether safety concerns identified with a related investigational gene therapy may apply to the licenced medicine.
whitepaper
Fact Sheet: Process analytical technology and real-time TOC testing of pharmaceutical grade water systems
Learn how Process Analytical Technology (PAT) and real-time TOC testing of pharmaceutical grade water systems can improve efficiency.
whitepaper
Catalogue: Standard cleanroom POD
G-CON’s standard POD maximises efficiencies in production, qualification and cost and eliminates the complexity of cleanroom construction projects.
news
February Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) began two new reviews and wrote guidance for healthcare professionals on the potential side effects of Strimvelis, Venclyxto and Zolgensma.
news
DECODR app identifies unintentional DNA mutations from CRISPR gene therapies
The DECODR app was developed to accelerate the development of CRISPR gene therapies, producing similar data as deep sequencing processes in a shorter timeframe and at less cost.
whitepaper
Whitepaper: Upstream process intensification
Strategies for upstream process intensification can be leveraged for cell line development, the seed train, production and cell culture media formulation.
whitepaper
Brochure: G-CON cleanroom POD
G-CON cleanroom PODs. Reliable, flexible prefabricated cleanrooms for the biopharmaceutical industry. On budget and on time.
whitepaper
Article: CCI test method development using headspace gas ingress
Update your blue dye ingress test and generate robust analytical CCI data in all stages of the product life cycle.
webinar
Comparing EMA and Health Canada CTA submission for Phase I trials to US FDA IND application
13 January 2021 | By Altasciences
Watch this webinar on-demand which presents an overview of a foreign health authority’s requirements for gaining approval to conduct an FIH clinical trial by comparing Health Canada and European Medicines Agency (EMA) Clinical Trial Authorisation (CTA) processes to that of the FDA IND submission.
whitepaper
Whitepaper: Turbocharging Raman measurements
This whitepaper describes the proprietary HyperFlux™ optical spectrometer designs developed by Tornado Spectral Systems.
whitepaper
Article: Regulatory guidance in designing a CCI testing strategy
A summary of the current state of container closure integrity testing in the pharmaceutical industry.
video
On-demand webinar: Best practices for cleaning and disinfection
This on-demand webinar focuses on the importance of cleaning and disinfection, covering legal requirements and the global guidelines for disinfection in cleanrooms.
whitepaper
Factsheet: Total Organic Carbon (TOC) back to basics
Total Organic Carbon (TOC) analysis is used to comply with compendia water testing requirements. Read this document to learn the basics on TOC.
