Although buffers are among the simplest materials used in bioprocessing, they are critical to biopharmaceutical manufacturing success. Buffer preparation, storage, and handling can require significant investments in time, labor, equipment, and facility space. Jenny Dunker, MSc, and Alexander Troken, PhD (global product managers for customized bioprocess solutions and for process liquids and buffers, respectively, at Cytiva), delivered an “Ask the Expert†presentation on 30 March 2021 to explore strategies for intensifying buffer management. Available Options Biopharmaceutical manufacturers often prepare buffers…
Friday, June 4, 2021 Daily Archives
Ask the Expert: Considerations for Mass Spectrometric HCP Analysis During Process Development
Host-cell proteins (HCPs) must be assessed early in biopharmaceutical product development to establish the efficiency of a purification process. Liquid chromatography coupled with mass spectrometry (LC-MS) is a strong orthogonal method for HCP identification and quantitation. During an 18 March 2021 “Ask the Expert†presentation, Christina Morris (senior scientist at BioPharmaSpec) explained how MS analyses can enhance process development (PD), then presented considerations for generating spectral libraries, selecting samples for quantitation, and reviewing data. Morris’s Presentation Spectral Libraries: A typical…
Cytiva looks to mechanistic modeling in GoSilico deal
Cytiva says the acquisition of scientific software maker GoSilico will boost its position of leadership in the chromatography and process development spaces. The deal, financials of which have not been divulged, sees vendor Cytiva acquire Germany’s GoSilico, adding a portfolio of scientific software based on mechanistic modeling for use in bioprocessing functions. “In the simplest of terms, mechanistic modeling uses software to model a process and predict how something is going to respond – think weather forecasting,†Olivier Loeillot, VP…
Resilience to support AavantiBio’s gene therapy programs long-term
AavantiBio has hired Resilience to make its gene therapies candidates, including a therapy for the currently untreatable progressive disorder Friedreich’s Ataxia (FA). Under the contract – described as a strategic collaboration – Resilience will provide process development and manufacturing as well as including cell lines and viral banks for in pre-clinical studies and clinical trials. The contract development and manufacturing organization (CDMO) will also develop and optimize processes for AvantBio’s other candidate therapies, with all of the work scheduled to…
MilliporeSigma ups lipid capacity by 50x to meet COVID-19 demand
To meet the high demand for lipids, MilliporeSigma has launched its high-purity synthetic cholesterol product nine months early. “By launching our new SAFC synthetic cholesterol product nine months early, we are able to meet the high demand for lipids that we’re seeing due to the COVID-19 pandemic, as lipids are a key component of mRNA-based vaccines and therapeutics,â€Â Matthias Bucerius, head of Actives & Formulation at MilliporeSigma told us.  The early launch of its cholesterol product has increased its capacity by 50 times.  According to the contract development manufacturing organization (CDMO),…