Insights On Quality Control
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Novel High-Resolution Instrument Helps Research Institute With Latest Development
4/6/2020
The University of Queensland’s Australian Institute for Bioengineering and Nanotechnology work includes studying cell ageing and regenerative engineering, precision nanomedicine, advanced materials, agriculture nanotechnology, and advanced biomanufacturing. Read more about their development of the first truly biomimetic hydrogel with help of an instrument that would be capable of being incorporated into a confocal-microscope system.
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How Successful CDMO Collaboration Sets The Foundation For Sterile Injectable Product Success
6/1/2021
In the realm of Sterile Injectables, sponsors come in a variety of sizes and with a range of experience levels. The same is true for CDMOs, and the dynamics of these outsourcing relationships have a huge influence on project success. Explore how a small or medium size biotech or pharma company can benefit from the experience and assistance provided by a CDMO.
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Container Closure Integrity Test Method Development Using Headspace Gas Ingress
3/18/2020
With no ‘gold standard’ container closure integrity (CCI) test, learn how to creating a toobox of CCI testing methods will allow you to be best prepared for every situation.
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Upstream Considerations For Biosimilar Development
1/11/2021
Understanding upstream challenges during biosimilar development and creating a strategy to overcome them is critical for ensuring a high chance of success with your biosimilar product.
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NMR And Mass Spectrometry In Pharmaceutical Development
10/26/2020
Together, nuclear magnetic resonance (NMR) and MS analysis can definitively identify reference standards, active pharmaceutical ingredients (APIs), or final drug product composition.
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Using DLS, ELS And SAXS To Study Ferric Nanoparticles Stabilized Using Different Oligosaccharides
4/13/2020
DLS and SAXS complement each other very well, since not only the particle size can be determined, but also information about particle shape and core-shell structures can be obtained. In addition, zeta potential measurements provide data about the stability of the sample. In the present application report we highlight the complementary results beneficial for characterizing different iron formulations for medical applications.
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Water Activity Determination Of Oral Solid Dosage Products Using Frequency Modulation Spectroscopy
6/18/2020
Controlling water content in oral solid dosage (OSD) products, and dry pharmaceutical products in general, is essential to maintaining efficacy and safety. Measuring the water activity at multiple time points during the product life-cycle will correlate to changes in critical quality attributes such as degradation of the active ingredient, changes in the dissolution or disintegration rate, and changes in physical properties such as hardness or friability.
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Determining CCI During Deep Cold Storage
7/23/2020
When working on live viral vaccines, gene therapies or product that contains active cells cold storage is often required to maintain stability and/or activity. Deep cold storage, at dry ice (-80°C) or even cryogenic (-196 °C) temperatures, poses a significant challenge to packaging components and can result in CCI failures. Watch this webinar for a detailed presentation on this topic.
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How To Understand ASTM E2500
12/21/2020
ASTM E2500 introduced the term “verification” but was essentially silent on the idea of “commissioning” and the term “qualification.” ASTM is a minimum standard, and teams are free to go beyond this minimum as long as the basic provisions are met. There are four basic approaches in the industry currently.
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Dimerization Of Bovine Serum Albumin As Evidenced By Particle Size And Molecular Mass Measurement
4/8/2020
Preparation methods have a large influence on the folding and oligomerization behavior of proteins in solution. Read how a useful tool can be used for the optimization of sample preparation and the quality control of proteins.