Inhalable drug formulations show much promise for improving biopharmaceutical delivery. But as Ashleigh Wake (director of business development at Intertek) explained to Ask the Expert attendees in September 2021, such formulations necessitate development of complex quality control (QC) analytical methods. Wake highlighted special considerations for characterizing and controlling the stability and potency of inhaled and nasally delivered biologics. Wake’s Presentation Wake emphasized that nasal and inhaled biological products necessitate QC strategies to control both a protein product and its delivery…
November-December 2021
Advancing Sterile-Connection Technology for Low-Volume Fluid Transfer
Biomanufacturers traditionally have relied on laminar-flow hoods or thermal tube welding to establish connections for small-format bioprocesses, including those for cell and gene therapy (CGT) production. But such strategies can introduce processing risks and can pose operational challenges. In October 2021, Troy Ostreng (senior product manager at CPC) described how his company’s MicroCNX sterile connectors could meet biomanufacturers’ needs for low-volume applications. Ostreng’s Presentation Welding tubes and forging open connections under laminar hoods raise several disadvantages for small-format bioprocesses. Processing…
A Practical Approach to Clinical Trial Diversity
A 2021 study in the Journal of the American Medical Association found that minority groups were underrepresented in US-based vaccine clinical trials, with white people accounting for ~80% of participants (1). Although researchers broadly acknowledge that trial representation should mirror the many different populations who could benefit from a drug, lack of diversity continues to hamper clinical-trial effectiveness. To address this problem, the pharmaceutical industry must increase awareness about clinical trials and reduce barriers to participation in them. Benefits of…