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
List view / Grid view
Next-Gen Sterile Sampling System: Pinnacle Compliance - USP Standards 87, 88, 85, 661.1, 788, 71, and ISO 11737-1 for Unparalleled Pharma & Biopharma
The pharma industry’s adaptation to Industry 4.0 has been slow, due to the extensive regulatory requirements imposed on manufacturers. However, regulatory agencies are starting to embrace movement towards more rapid/automated systems, as illustrated in the revised EU GMP Annex 1, which entered into force in August. Here, Isabella Jul-Jørgensen from the Technical…
To address the perceived barrier to entry for rapid microbiological methods, new validation packages are now available for Celsis® rapid microbial detection.
Nitrosamine genotoxins in several pharmaceuticals has led to monitoring of manufacturing practices for products considered at risk.
Nitrosamine impurities have become a concern in the bio/pharmaceutical industries, due to their carcinogenic properties and presence in medications.
Discover the benefits of liquid-filled capsules for the formulation of highly potent APIs and drugs that benefit from slow or extended release.
16 August 2023 | By Rapid Micro Biosystems
Watch this webinar with independent microbiology expert Dr Tim Sandle to explore the different technologies, regulatory concerns and validation requirements for automated colony counting methods.
Altasciences has published an ebook sharing comprehensive information about testing biomarkers of immunomodulation as part of your drug development program.
Altasciences’ Proactive Drug Development can accelerate the development of small molecules by up to 40%, from lead identification to clinical POC.
How the GMP requirements affect the manufacturing of sterile medicinal products from European Member States and products imported from outside Europe.
Digitalisation is a driving factor for the global process analytical technology (PAT) market, according to a report.
The advanced rapid validation tool for measuring hydrogen peroxide bio-decontamination performance that’s transforming the validation process in pharmaceutical manufacturing and other applications including healthcare and research.
Read this case study to learn how a pharmaceutical company used Accugenix Whole Genome Sequencing for bacterial and fungal ID.
CNS drug development is complex, and partnering with an integrated CRO/CDMO can reduce your timelines by up to 40%. Learn more in The Altascientist.
Lipid-based Nano Particles form a very useful class of delivery systems in the pharmaceutical area as well as in cosmetics (and food/nutraceuticals).