news
Merck elevates its BioContinuum platform strategy to deliver ‘ContiGuous’ bioprocessing
Launch is taking place at the International Pharmaceutical Expo (INTERPHEX) in New York
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Bioprocessing
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Paving the way to a bright future for single-use bioprocessing
Pharmaceutical and biotech companies together offer life-changing or, more appropriately, life-saving medicines and materials containing medicines for patients across the world. To ensure demand is met and patients’ health is not compromised, it is essential a strong and secure supply chain is in place to support the drug development lifecycle.…
news
Industry experts combine to create safer intravenous delivery
The Italian Biochemical Institute, Comecer, and Particle Measuring Systems share expertise to develop and manufacture a safer intravenous solution...
product
Product Hub: Multitron incubation shaker
The Multitron is the number-one choice for reliable, convenient cultivation of microorganisms and cell cultures. The incubation shaker guarantees homogeneous conditions and delivers reproducible results, leaving nothing to be desired regarding its features and capacity.
news
BPSA releases guide to production of cell and gene therapies
The Bio-Process Systems Alliance, the primary international industry association for single-use bio-processing, is pleased to announce the release of its latest whitepaper...
whitepaper
Whitepaper: Analytical criteria in bacterial endotoxin testing using LAL and rFC
This article covers the analytical criteria that apply to Bacterial Endotoxin Testing (BET) using Limulus Amebocyte Lysate (LAL) or recombinant Horseshoe crab Factor C (rFC) for the bioactivity determination of endotoxin in aqueous solutions, such as pharmaceuticals and medical device extracts. It explains the importance of these criteria for accurate…
webinar
Applying quality risk management to develop an isolator filling line
11 February 2019 | By Particle Measuring Systems
Following the patent of the "Espresso" innovative infusion device, the Italian Biochemical Institute (IBI) "Lorenzini" commissioned Comecer to construct a new isolated filling line.
news
ProCellics™ software new release
ProCellics™ software is available with ProCellics™ GMP bioprocess in-line analyser. ProCellics™ software has been specifically developed to address bioprocess monitoring needs...
article
Expert View: Beyond API monitoring: in‑line Raman spectroscopy for bioprocess monitoring and control
The FDA’s Quality by Design (QbD) initiative brought a paradigm shift to pharmaceutical manufacturing and leading manufacturers have realised improved processes after adopting QbD. Raman spectroscopy is an established Process Analytical Technology (PAT), enabling QbD and continuous approaches to pharmaceutical manufacturing.1
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Navigating roadblocks to clinical success: from molecule to clinic
For emerging biotech and small companies in early-stage clinical development, accessing the market as quickly as possible is of paramount importance. Biopharma executives must make important decisions at this stage that will impact the success of their commercial strategy. The key to success is making the right decisions at the…
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Biopharma, Processing & Development In-Depth Focus 2018
In this supplement: navigating roadblocks to clinical success, and the data challenges of R&D and collaboration.
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Issue 6, 2018
In this issue: Navigating roadblocks to clinical success: decision-making from molecule to clinic, Raman spectroscopy for the qualitative analysis of falsified and substandard medicines, and an overview of risk assessments for elemental impurities: implementation of ICH Q3D guidelines.
news
Ensuring supplier and compounded drug quality
It is paramount that manufacturers and their suppliers ensure that the quality of compounded drugs are high, by preventing risks of contamination...
news
Data integrity and compliance with drug current good manufacturing practices
The FDA has provided guidance on data integrity and compliance; two areas extremely important for pharmaceutical businesses and manufacturers to adhere to...
whitepaper
Application Note: Representative sampling of solids and turbid media in process raman spectroscopy
Raman spectroscopy is an analysis technique that provides a “molecular fingerprint” of the sample, enabling analysis of chemical composition and molecular structure without sample preparation. As a measurement technique, Raman imparts many benefits in applications from laboratory discoveries to feedback-control in manufacturing.
