Olivia Jefferies, Elizabeth Margerison and Asmita Khanolkar introduce Oval’s work on using ultrasound scanning and finite element analysis to construct a model of how tissue compresses under use of an autoinjector across patient demographics, and how this may provide insights into improved autoinjector design for more accurate injection depths, improving patient outcomes.
Antonio Costa discusses the use of lipid nanoparticles in the modern drug delivery industry and introduces the DIANT system for the continuous processing of nanoparticles with integrated process analytical technology, which can provide the quality required for these injectable, complex formulations.
Caroline Zakrzewski considers the interaction between formulation and device development and the challenges that drive innovation in the field. Her work frequently sits in the overlap between formulation and device development, navigating the interwoven steps that lead to the sweet spot, where formulation and a device work in tandem, providing safe and effective delivery of the drug.
COMPARATIVE EXTRACTABLE STUDIES FOR INJECTABLES AND MEDICAL DEVICES ALIGNED WITH USP <1663> AND ISO 10993 GUIDELINES
Matthias Bicker, Michael Müller, Marc Mittermüller, Daniel Haines and Uwe Rothhaar discuss the regulatory requirements that need to be considered when designing an extractables and leachables study for a drug product or medical device. To illustrate the subject further, the authors provide two example studies, each following a different set of regulatory guidelines.
Benjamin Dietiker, Weidmann Medical Technology, talks with ONdrugDelivery about how the company has successfully implemented a growth strategy by focusing on key areas, plans for expansion, the effect of covid-19 on the business, and how the company differentiates itself from larger competitors by focusing on quality and service.
Andrea Cusack discusses how, by using bottom-up nanotechnology techniques, efficiencies can be found both in the development of new chemical entities and in the repurposing of existing drugs, and how these efficiencies translate into reduced energy requirements and therefore more sustainable industry practices.
FROM FORMULATION TO MANUFACTURING: LIPID NANOPARTICLE mRNA VACCINES, GENE THERAPIES & OTHER NANOMEDICINES
MedinCell investigating role of long-acting antivirals to break chain of SARS-COV-2 viral transmission
With evidence indicating that the established antiparasitic ivermectin can kill coronavirus in a laboratory setting in under 48 hours, MedinCell has published data showing that long-acting formulations of ivermectin can be designed with varying doses and durations with its BEPO® technology and is investigating whether a long-acting product could be effective in breaking the chain of viral transmission.
Lexaria Bioscience Expands Pharma Division for development of Lipophilic Antivirals against COVID-19
Over the past year, Cristal Therapeutics has transitioned from a research-stage start-up to a fully fledged, clinical-stage business with a promising pipeline of proprietary drug candidates. This diverse pipeline together with the proprietary nanoparticle platform, CriPec®, presents a broad range of promising late- and early-stage partnering opportunities for companies active in the oncology space.
Elektrofi introduces Elektroject™, a gentle process for the production of ultra-high concentration protein formulations, that maintains a syringeable format and excellent protein stability, making the switch from intravenous to subcutaneous delivery viable for numerous biotherapeutics, including monoclonal antibodies.