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FORMULATION

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XERIJECT™: NON-AQUEOUS FORMULATIONS FOR SC INJECTION OF ULTRA-HIGH-CONCENTRATION BIOLOGICS

Steven Prestrelski introduces the XeriJect non-aqueous formulation technology that creates formulations with visco-elastic properties, opening the door to subcutaneous injection of difficult-to-formulate biologics, such as monoclonal antibodies, at very high concentrations.

ENABLING A NEW PARADIGM FOR PEPTIDE DRUG DEVELOPMENT

Michael Neely reviews peptide formulations and introduces Xeris's XeriSol™ technology and its potential paradigm-changing capabilities.

DEVELOPING AN ON-BODY PLATFORM FOR EFFECTIVE POST-OPERATIVE PAIN MANAGEMENT

Stevanato Group

DEVELOPING AN ON-BODY PLATFORM FOR EFFECTIVE POST-OPERATIVE PAIN MANAGEMENT

Paolo Golfetto and Sheldon Moberg discuss a collaboration between Stevanato Group and Bexson Biomedical that meets an urgent unmet patient need.

SINGLE USE SYSTEMS – THE FUTURE OF BIOPHARMACEUTICAL PROCESSING

SINGLE USE SYSTEMS – THE FUTURE OF BIOPHARMACEUTICAL PROCESSING

Jeff Lowe considers single-use systems and looks at their role in the future of biopharmaceutical processing.

EXTRACELLULAR VESICLE ENGINEERING: OPTIMISING NATURE’S NON-IMMUNOGENIC, DRUG DELIVERY PLATFORM

Dr Anna Cifuentes-Rius

EXTRACELLULAR VESICLE ENGINEERING: OPTIMISING NATURE’S NON-IMMUNOGENIC, DRUG DELIVERY PLATFORM

Anna Cifuentes-Rius discusses the exciting potential of extracellular vesicles to advance drug delivery, in particular their natural ability to carry API payloads across difficult-to-traverse biological barriers.

RECENT TRENDS & DEVELOPMENTS IN INJECTABLE FORMULATION & DELIVERY

Dr Martin Gonzalez

RECENT TRENDS & DEVELOPMENTS IN INJECTABLE FORMULATION & DELIVERY

Martin Gonzalez details current trends in sterile injectable formulations and their delivery devices, and the challenges pharma and its contract development and manufacturing company partners face in bringing emerging breakthroughs to market.

OPHTHALMIC INJECTION OF VISCOUS FORMULATIONS – WHY UNIQUE NEEDS REQUIRE A NOVEL DELIVERY APPROACH

Dr Gautam N Shetty

Congruence Medical Solutions

OPHTHALMIC INJECTION OF VISCOUS FORMULATIONS – WHY UNIQUE NEEDS REQUIRE A NOVEL DELIVERY APPROACH

Guatam Shetty and Richard Whelton outline the key considerations related to ophthalmic injection of viscous formulations and propose an innovative, user-validated and fully mechanical device-based solution.

A VIEW ON THE USE OF APROTIC SOLVENTS IN PARENTERAL DRUG FORMULATIONS

A VIEW ON THE USE OF APROTIC SOLVENTS IN PARENTERAL DRUG FORMULATIONS

Michael Neely presents a review and discussion of the status of aprotic solvents as a solubilising vehicle for parenteral drug formulations in the context of the industry’s increasing interest in biologic drugs.

COMPUTATIONAL MODELLING OF INJECTION-RELATED TISSUE RESPONSES IN DRUG DELIVERY

Olivia Jefferies

COMPUTATIONAL MODELLING OF INJECTION-RELATED TISSUE RESPONSES IN DRUG DELIVERY

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.

FORMULATION DEVELOPMENT AND DRUG DELIVERY: JOINED AT THE DEVICE

Julie Cotterell

FORMULATION DEVELOPMENT AND DRUG DELIVERY: JOINED AT THE DEVICE

Julie Cotterell discusses the major factors at play driving the direction of innovation in the subcutaneous drug delivery space, with a particular emphasis on the push towards patient self-administration.

THREE PHASES TO SUCCESS IN STERILE INJECTABLES TECHNOLOGY TRANSFER

Pfizer CentreOne

THREE PHASES TO SUCCESS IN STERILE INJECTABLES TECHNOLOGY TRANSFER

Jennifer Quint offers insights into how to plan and execute technology transfer effectively, explaining Pfizer CentreOne’s three-phased approach that can successfully support this pivotal event in a drug product programme’s journey to commercialisation.

ENHANCED PROCESS CONTROL FOR LIPID-BASED NANOPARTICLES: LNPS AND LIPOSOMES

Dr Antonio Costa

ENHANCED PROCESS CONTROL FOR LIPID-BASED NANOPARTICLES: LNPS AND LIPOSOMES

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.

AUTOMATED LIPID NANOPARTICLE PRODUCTION: FROM PROTOCOL DEVELOPMENT TO GMP MANUFACTURE

AUTOMATED LIPID NANOPARTICLE PRODUCTION: FROM PROTOCOL DEVELOPMENT TO GMP MANUFACTURE

Richard Gray and Julia Rashba-Step discuss the benefits of automated lipid nanoparticle production.

FORMULATION & DEVICE DEVELOPMENT: A SYMBIOTIC RELATIONSHIP

Caroline Zakrzewski

Cambridge Design Partnership

FORMULATION & DEVICE DEVELOPMENT: A SYMBIOTIC RELATIONSHIP

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.

ADDRESSING THE CHALLENGES OF VISCOUS INJECTABLE ADMINISTRATION

Dr Andrew Donnelly

ADDRESSING THE CHALLENGES OF VISCOUS INJECTABLE ADMINISTRATION

Andrew Donnelly and Shahid Uddin look at the challenges of self-administration of injectable viscous formulations and the technology that is helping to overcome these issues.

COMPARATIVE EXTRACTABLE STUDIES FOR INJECTABLES AND MEDICAL DEVICES ALIGNED WITH USP <1663> AND ISO 10993 GUIDELINES

Dr Matthias Bicker

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.

INTERVIEW WITH BENJAMIN DIETIKER, WEIDMANN MEDICAL TECHNOLOGY

Benjamin Dietiker

Weidmann Medical Technology

INTERVIEW WITH BENJAMIN DIETIKER, WEIDMANN MEDICAL TECHNOLOGY

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.

ROOM FOR INNOVATION?

ROOM FOR INNOVATION?

Darren Mansell examines US FDA guidance on biosimilar interchangeability and asks whether there is room for innovation.

NANOTECHNOLOGY: A PATHWAY FOR SUSTAINABLE INNOVATION IN DRUG DEVELOPMENT

NANOTECHNOLOGY: A PATHWAY FOR SUSTAINABLE INNOVATION IN DRUG DEVELOPMENT

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

INDUSTRIALISATION

FROM FORMULATION TO MANUFACTURING: LIPID NANOPARTICLE mRNA VACCINES, GENE THERAPIES & OTHER NANOMEDICINES

Stephen Allan reviews the history and formulation advantages of lipid nanoparticles (LNPs) and addresses factors that should be considered by pharmaceutical companies during the CDMO selection process to help reduce regulatory risk, improve product performance and accelerate speed to market.

SILICA RE-EMERGES AS POTENTIAL NUCLEIC ACID DELIVERY VECTOR

SILICA RE-EMERGES AS POTENTIAL NUCLEIC ACID DELIVERY VECTOR

Nigel Theobald looks at the challenges of oligonucleotide delivery and explores approaches to overcome them.

MedinCell investigating role of long-acting antivirals to break chain of SARS-COV-2 viral transmission

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

Lexaria Bioscience

Lexaria Bioscience Expands Pharma Division for development of Lipophilic Antivirals against COVID-19

Lexaria is to investigate how its patented DehydraTECH drug delivery technology could enhance delivery and effectiveness of certain antiviral drugs in the fight against coronavirus disease COVID-19. Lexaria intends to expand collaboration with leading laboratories as soon as possible.

COMPANY SHOWCASE: Cristal Therapeutics

Dr Cristianne Rijcken

Cristal Therapeutics

COMPANY SHOWCASE: Cristal Therapeutics

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.

ENABLING SUBCUTANEOUS DELIVERY OF BIOLOGICS

ENABLING SUBCUTANEOUS DELIVERY OF BIOLOGICS

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.

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