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Video series: The champions of iCON: A collaborative discussion on global turnkey solutions (Part 1)
iCON has improved delivery capacity by standardising the infrastructure for a flexible and readily available drug manufacturing facility.
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Gene therapy
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Application sheet: Mobile testing LabPODs
Readily deployable, fully integrated mobile testing labs for fast-track delivery of diagnostic and analytical lab capability where and when needed.
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Whitepaper: Transmissible disease defense unit
The use of flexible mobile biocontainment and test units to prevent the spread of transmissible diseases.
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EMA’s transformative treatments of 2020
In this article, we summarise the trial findings for the European Medicines Agency’s 13 most transformative therapies of 2020.
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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.
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.
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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.
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Catalogue: Standard cleanroom POD
G-CON’s standard POD maximises efficiencies in production, qualification and cost and eliminates the complexity of cleanroom construction projects.
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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.
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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.
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Brochure: G-CON cleanroom POD
G-CON cleanroom PODs. Reliable, flexible prefabricated cleanrooms for the biopharmaceutical industry. On budget and on time.
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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.
