Gastric delivery is unachievable for most biopharmaceuticals, so drug developers formulate biologics primarily for intravenous infusion or injection. However, inhaled and nasal delivery options are attracting considerable attention because they enable targeted delivery of a wide range of therapeutic proteins. On 23 June 2020, Mark Parry (technical director at Intertek) presented an “Ask the Expert†webinar that described critical considerations for inhaled and nasal delivery for biologics. Parry’s Presentation Because biopharmaceuticals are complex products, developers need compelling reasons to choose…
Tuesday, September 22, 2020 Daily Archives
Ask the Expert: Ultrapure Gelatin Can Optimize Your Excipient Screening for Vaccine Formulation
In his 28 May 2020 “Ask the Expert†presentation, Jeroen Geeraerts (business development manager at Rousselot) highlighted that, as of May 2020, 118 candidate vaccines for the novel coronavirus (SARS-CoV-2) had reached clinical or preclinical evaluation. Of those, 11 use inactivated and live–attenuated approaches, which require strong stabilizing agents to maintain vaccine potency. Geeraerts explained why inactivated and live–attenuated vaccines require stabilizing agents and why vaccine companies prefer pharmaceutical-grade gelatin for such applications. Next, Geeraerts described how his company’s X-Pure…
Ask the Expert: An Innovative System for Advanced, High-Throughput Aggregate Analysis
Distinguishing aggregated active pharmaceutical ingredients (APIs) from other particle types is critical to evaluating a protein product’s stability, but standard characterization tools struggle to discriminate proteins from nonproteins with similar sizes, shapes, and morphologies. In a 25 June 2020 “Ask the Expert†webcast, Bernardo Cordovez (founder and chief scientific officer of Halo Labs) introduced his company’s Aura subvisible-particle analyzer. He explained how the device combines an innovative microscopy technique with sophisticated imaging software to characterize subvisible particles more quickly and…
Vaxart taking COVID-19 tablet vaccine into clinic
Vaxart may not be the first to commercialize a COVID-19 vaccine, but the firm says the ease of administration and stability of its oral tablet could provide a comprehensive and long-term solution to this global pandemic. South San Francisco-based firm Vaxart is developing an oral vaccine – administered by tablet rather than by injection – against COVID-19, caused by the novel coronavirus (SARS-CoV-2). The firm recently announced the US Food and Drug Administration (FDA) has completed its review of an…
Samsung Bio adds another Big Pharma customer with $331m AstraZeneca deal
AstraZeneca will grow its production network into Asia-Pacific through a contract with Korean CDMO Samsung Biologics for large-scale drug substance manufacturing. Anglo-Swedish pharma firm AstraZeneca is teaming with contract development and manufacturing organization (CDMO) Samsung Biologics in a long-term deal worth an initial $330.8 million, though this could rise to $545.6 million. The specific products to be made at Samsung Biologics’ site in Incheon, South Korea have not been disclosed but AstraZeneca has numerous biologics commercially available and a number…