October 2022

COVER

EXTRACELLULAR VESICLES - Engineering Extracellular Vesicles to Create Next-Generation Therapeutics

David Lowe, PhD, Justin Hean, PhD, Dave Carter, PhD, and Antonin de Fougerolles, PhD, say EVs exhibit key properties that make them extremely attractive as therapeutics, particularly their safety profile and potential for low immunogenicity. In order to effectively unlock this potential, some key challenges remain, such as the development of EV product manufacture and characterization methodologies and rapid pharmacokinetics.

FEATURES

EXTRACELLULAR VESICLES - Engineering Extracellular Vesicles to Create Next-Generation Therapeutics

David Lowe, PhD, Justin Hean, PhD, Dave Carter, PhD, and Antonin de Fougerolles, PhD, say EVs exhibit key properties that make them extremely attractive as therapeutics, particularly their safety profile and potential for low immunogenicity. In order to effectively unlock this potential, some key challenges remain, such as the development of EV product manufacture and characterization methodologies and rapid pharmacokinetics.

MEDICAL DEVICE TESTING - Chemical Characterization & the Non-Targeted Analysis of Medical Devices

Luminita Moraru, MSC, MRSC, says the medical devices industry is in continuous growth, and the development of new reliable and accurate approaches in order to assess the safety of the products should constantly be reviewed.

EXECUTIVE INTERVIEW - Owen Mumford & Stevanato Group: Collaborating to Produce Aidaptus® Auto-injector

Michael Earl, Director of Pharmaceutical Services at Owen Mumford, and Steven Kaufman, Vice President for Drug Delivery Systems at Stevanato Group, discuss their collaboration in producing the innovative Aidaptus auto-injector.

EXCIPIENT COMPACTION STUDY - Developing a Reliable Controlled-Release Polymer Using a Compaction Simulator

Gopeshkumar Singh, MS, and Ajit Bhagat provide study results showing that through polymer chemistry, it is viable to effectively manufacture matrix tablets via a simple direct compression method; and Hypromellose has impressive compatibility at various compression forces.

CLINICAL TRIALS - Quality Matters in an Evolving Clinical Trial Landscape

John Buchan reviews best practices for achieving quality by addressing challenges focused on the all-important but growing complexity of managing the distribution of critical safety documents and the processing of Individual Case Study Reports and aggregate reports to sites, Ethic Committees (ECs), IRBs, and others in the reporting chain.

EXECUTIVE INTERVIEW - Credence MedSystems: Implementing a Flexible Manufacturing Line to Deliver Innovation in Drug Delivery to the Pharmaceutical Industry

Jeffrey Tillack, Chief Operating Officer at Credence MedSystems, discusses the challenges being addressed by his innovative technology and the role its new Flex Line will play in the company’s scaling strategy.

DRUG DISCOVERY - Getting the Most From a DNA-Encoded Library Screen

Matthew A. Clark, PhD, says despite this high level of interest, there remains variable understanding of how to maximize the potential of a DEL screen, and shares his company’s approach to DEL screening and how its partners get the most from this powerful technology.

PLATFORM TECHNOLOGY - The Evolution of Cancer Vaccines: Moving Beyond Failure & a New Era for Cancer Treatment

Jeremy R. Graff, PhD, says new studies show promising data with the use of mRNA-based vaccines and the injection of nanoparticles into regional lymph nodes to achieve disease stabilization. This has led to a potentially groundbreaking era of therapeutic cancer vaccines thanks to discoveries in identifying truncal targets, targeting tumor neoantigens and, notably, developing improved delivery technologies that stimulate a robust, targeted, and persistent immune response.

NANOPARTICLE ENGINEERING - Lighting the Way to a Patient-Centric Future

Christopher Worrall, PhD, discusses how nanoparticle engineering technologies could help improve compliance and patient outcomes, for both small-molecule and biological drugs, and how nanotechnology can help facilitate a shift toward more patient-centric medicine.

TOP SPRAY GRANULATION - POLYOX™: Producing Lightweight Metformin Hydrochloride Extended-Release Tablets for Patient Adherence & Cost-Effective Manufacturing

Atul Lohade, PhD, Vinay Muley, and Tejas Gunjikar, PhD, explain how understanding the challenges associated with developing smaller extended-release tablets, and the excipient-based solutions to these challenges, will empower formulators to develop robust, stable drug formulations with high patient adherence while cutting manufacturing costs.