news
GCD enables product traceability and batch definition in continuous biomanufacturing
Research shows using the greatest common divisor (GCD) to define batches in continuous biomanufacturing enhances process control and raw material traceability.
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Biologics
whitepaper
Application note: Impurity analysis of gabapentin by HPLC-UV-CAD
This application aims to replace the two separate compendial methods for the impurity analysis of gabapentin with one single HPLC method.
whitepaper
Application note: Scale Up Assist can help antibody workflow
This study details the use of the new Scale Up Assist feature of the BioFlo 720 Bioreactor Control System to scale CHO batch cultures.
podcasts
EPR Podcast Episode 5 – ATMP manufacturing and QC – Rey Mali, Accellix and Félix Montero-Julian, bioMérieux
Join Rey Mali and Félix Montero-Julian as they discuss the challenges facing the manufacture and QC of advanced therapy medicinal products (ATMPs) and potential solutions.
video
On-demand webinar: Water systems – microbial monitoring
This webinar considers the fundamental importance of water system control within pharma processing and the best control and monitoring practices.
whitepaper
Whitepaper: Impact of a pandemic outbreak on vaccine development approach
This whitepaper explores vaccine development during a pandemic, a response to complex challenges that traditional manufacturing methods will not solve.
article
Developing and delivering live biotherapeutic products
The microbial content of the gut has a well established role in health and disease. In this article, European Pharmaceutical Review’s Hannah Balfour explores the development and formulation of live biotherapeutic products (LBPs), an emerging treatment modality that seeks to capitalise on the interaction between the microbiota and host in…
whitepaper
Press release: Telstar: 360 degrees GMP consultancy & engineering solutions at CPhI
Telstar promotes innovative aseptic production solutions in a setting marked by the new GMP Annex 1.
article
The race to get biotech innovation to market: five steps to success
Achieving prompt and profitable market access for new pharma products has never been more challenging. Next-generation drug launches are increasing in number year on year, creating strong competition, and treatments are becoming more tightly targeted, reducing the size of available markets. In addition, biologic drugs are highly complex and expensive…
whitepaper
Toolkit: Nitrosamine analysis workflows
Everything you need to have confidence and compliance in your nitrosamine impurity analysis.
news
Tremfya® shows promise in Phase III psoriatic arthritis study
Tremfya inhibited radiographic progression and provided durable improvements in symptoms of axial involvement in psoriatic arthritis patients.
article
Continuous biomanufacturing – where are we now?
The biopharmaceutical industry is driven by the need to increase production and reduce costs, while maintaining product quality – and has increasingly been focused on intensification of processes to accomplish this goal. In this article, European Pharmaceutical Review’s Hannah Balfour summarises the potential benefits of implementing continuous bioprocessing and manufacturing…
article
Designing an ATMP manufacturing facility: from concept to completion
Remy Martin, business development specialist at cell and gene therapy manufacturing consultant, eXmoor Pharma, discusses 10 key considerations when creating a manufacturing facility, to ensure it meets requirements for both immediate needs and future growth.
news
X-ray imaging enables automated parenteral product particulate inspection
X-ray imaging was able to detect all common particulates in lyophilised drug product and provide information of the cake structure in a new study.
article
Formulation, Development & Delivery In-Depth Focus 2021
Discover how to plan for post‑market clinical follow-up compliance under the new EU Medical Device Regulation (MDR), and formulate live biotherapeutic products to enhance their effects in this in-depth focus.
