All Upstream processing articles – Page 6
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ArticleThe benefits of mass spectrometry for expediting biologics to patients
A key element of development for new molecular format biological products is to leverage the appropriate analytical tools to enhance product and process understanding throughout the development lifecycle. Here, Ian Anderson, Mostafa Zarei and Qifeng Zhang at Lonza highlight the benefits of using mass spectrometry technologies to accelerate and de-risk ...
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Webinar
RMMs and endotoxin testing: efficiency gains and regulatory perspectives
Learn how Rapid Microbiological Methods can provide results in less than 45 minutes and endotoxin assays can be set up in less than 10 minutes to improve contamination control and reduce risk.
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NewsUK ATMP facility granted cGMP approval
A UK CDMO is now permitted through MHRA certification to produce clinical supply of gene therapy AAV, including bioprocess through to cGMP manufacturing.
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ArticleHow breakthrough CAR-T cancer therapies could be made more widely accessible
The development and regulatory approval of the first autologous CAR T-cell therapies is a huge advance for modern medicine and has been greeted with justifiable excitement. But applications of this technology are still limited, and given the time and cost constraints, more must be done to broaden access to this ...
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ArticleImplementing the future of mRNA therapeutics
Here, Chief Scientist Bruce Lahn of the CDMO VectorBuilder discusses best practices, common problems, and possible solutions to mitigate risk and free up capacity when developing and designing mRNA therapeutics.
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NewsMicrobiome therapy manufacturing facility completed
Europe’s largest microbiome ecosystem therapies manufacturing facility is set to begin production by the end of Q3 2023.
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Whitepaper
Technical document: Introducing: Ami Polymer's Sterile Sampling Systems
Next-Gen Sterile Sampling System: Pinnacle Compliance - USP Standards 87, 88, 85, 661.1, 788, 71, and ISO 11737-1 for Unparalleled Pharma & Biopharma
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ArticleBioprocessing & Bioproduction In-Depth Focus 2023
In this in-depth focus are articles on reducing production time for allogenic CAR T-cell therapies and the complexities of mRNA development, from design intricacies to scalability.
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NewsMiniaturised PAT tool demonstrates real-time aggregation measurement
Researchers have described how a process analytical technologies (PAT) fluorescent dye (FD)-based microfluidic sensor facilitated immediate feedback and control of process parameters for continuous downstream processing.
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ArticleEuropean Pharmaceutical Review Issue 4 2023
EPR Issue 4 includes articles on fridge-free vaccines, dry powder drug delivery, Annex 1, contamination control strategy and more.
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NewsAI/ML to drive bioprocess containers market
The biopharma industry will see more customisation in the design of bioprocess containers in the next five years, a market report has predicted.
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Whitepaper
Whitepaper: Are nitrosamines a concern for biologic manufacturers?
Nitrosamine genotoxins in several pharmaceuticals has led to monitoring of manufacturing practices for products considered at risk.
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Whitepaper
Whitepaper: Navigating nitrosamine impurity testing
Nitrosamine impurities have become a concern in the bio/pharmaceutical industries, due to their carcinogenic properties and presence in medications.
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NewsCDMO to manufacture SARS-CoV-2 intranasal vaccine
In a collaboration between the Institutes of Health (NIH) and CDMO Exothera, an intranasal vaccine for SARS-CoV-2 will be manufactured for use in a clinical Phase I/II trial in Africa and the US.
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NewsAccelerating biomanufacturing with automated PAT systems
Experts at Amgen have highlighted a micro sequential injection (µSI) process analyser and automatic assay preparation platform (A2P2) as an autonomous process analytical technology (PAT) platform to enable rapid testing and release of biopharmaceutical products.
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ArticlePreparing for stricter standards on substances of human origin
Manufacturers of innovative therapies and other stakeholders handling blood, tissues and cells must prepare for stronger European rules. Ulf Grundmann, Elisabeth Kohoutek and Lara Sophie Hucklenbroich of King & Spalding elaborate on what this means for manufacturers of advanced therapy medicinal products.
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NewsHow can PAT help advance biologics manufacturing?
Lonza’s Associate Director of R&D has offered insight on implementing process analytical technology (PAT) into biologics manufacturing using real-world examples.
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Video
Video: The EU Annex 1 Good Manufacturing Process (GMP) updated requirements
How the GMP requirements affect the manufacturing of sterile medicinal products from European Member States and products imported from outside Europe.
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NewsInnovative PAT-based filtration strategy reported for continuous biomanufacturing
The PAT-based approach is the first of its kind to prevent membrane fouling when using a robust single-pass tangential flow filtration (SP-TFF) operation in bioprocessing, according to a paper.
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NewsSustainable pharmaceuticals: what about pine-based painkillers?
UK researchers have developed two of the world’s most common painkillers from a pine-derived compound, meaning new sustainable turpentine-based pharmaceuticals could be on their way.