INSIGHTS ON QUALITY CONTROL

• Upstream Considerations For Biosimilar Development

  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.

• Shedding Light On Insulin Aggregation With The Litesizer 500

  Formulation of stable protein drugs is challenging, as most proteins are sensitive to sunlight, high and low temperatures, pH, and so on. This application note demonstrates how protein aggregation can be monitored, particle size and particle
  mass can be measured quickly and conveniently by using light scattering techniques. Furthermore, the transmittance can also provide a very rapid indication of the extent of aggregation.

• How Successful CDMO Collaboration Sets The Foundation For Sterile Injectable Product Success

  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.

• Molecular Mass Of Lysozyme Determined By Static Light Scattering

  Static Light Scattering (SLS) measures the time-averaged intensity of scattered light. It is a typical method for determining the molecular mass of macromolecules, in particular that of proteins. This application demonstrates how the molecular mass of lysozyme can be determined by static light scattering measurement with excellent accuracy and repeatability.

• Principles Of Raman Spectroscopy And Application To Pharmaceutical Development

  10/26/2020

  Discover how Raman spectroscopy is used to analyze a chemical compound’s structure and an example of how this technique is used to analyze amorphous material created through a hot melt extrusion process.

• Hardness Testing Of Soft Biomaterials And Hydrogels By Indentation Analysis

  8/11/2021

  As nanoindentation methods have evolved, so too have the innovative solutions for performing this critical testing, such as the Bioindenter instrument from Anton Paar.

• What Are GxPs And How Do They Shape The Quality Of Your Pharmaceutical Product?

  5/4/2021

  Understanding and following GxPs helps to mitigate crucial business risk and improve product quality. Pharmaceutical companies should apply GxPs and the best scientific technology in their quality management systems.

• Ensuring Container Closure Integrity Of A Gene Therapy Cancer Vaccine Needing Deep Cold Storage

  7/22/2020

  A gene therapy clinical trial was halted due to CCI issues in deep cold storage. A CCI test method was developed that enabled non-destructive CCI testing of product vials at these cold temperatures. The capability to non-destructively test clinical product in deep cold storage enabled troubleshooting studies leading to corrective actions that assured good CCI.

• OPTIMA 7000 Fill Line

  6/7/2021

  Ajinomoto Bio-Pharma Services is a leader in aseptic filling, offering a wide range of capabilities for vials with our OPTIMA 7000 fill line. The OPTIMA VFVM 7000 safely processes various types and classes of biopharmaceutical products in 2 mL to 100 mL sizes.