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Issue 5 2019
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The International Conference on Harmonisation (ICH) is drafting guidance for product lifecycle management (ICH Q12) – currently stage 2b, which requires application of the concepts of Quality by Design (QbD) to ongoing lifecycle management and change control. Dave Elder dissects the guidance and discusses considerations for industry professionals.
Over the last few years, biologics have continued to make up an increasing proportion of biopharmaceutical sales and pipeline candidates. Cory E Muraco and Wayne Way discuss current trends in biologics analysis.
Medicines are heavily regulated during development, manufacture and distribution.
Lonza Pharma & Biotech is the leader in capsule-based solutions and services, proudly offering Capsugel® products.
As the partner of choice for managing microbial quality control, Charles River’s products and services facilitate confident and objective decision-making, ensuring the integrity of your microbial data, reducing risk, building efficiency and improving your bottom line, while assisting in the journey to bring products to market.
At Lonza Pharma & Biotech we provide contract development and manufacturing services that enable pharma and biotech companies to bring medicines to patients in need.
CLEANING AND microbial contamination control are critical focus areas in the pharmaceutical and medical device industries.
Application note: Comprehensive cell culture profiling of iPS cells using LCMS Q-TOF – simultaneous analysis of SIM and Scan mode in a single run
In this work we report the metabolic analysis of cell cultures using a high-resolution accurate mass LCMS/MS Q-TOF platform to identify metabolite markers of genomics and phenotypic changes.
Included in this in-depth focus are articles on using vitamins and fatty acids as APIs as well as the trends that have influenced the global excipients market.
In this in-depth focus are articles on consistent analytical techniques when changing laboratories and using chromatographic techniques to identify impurities in radiopharmaceuticals.