2022_PA_Consulting_Biomimicry_leaderboard1

OCULAR

DRUG DELIVERY PLATFORM DRIVES NEW OPPORTUNITIES FOR CONTINUOUS-DELIVERY GLAUCOMA TREATMENT

Harsh Patel, Cyonna Holmes and Brian Wilson discuss how Celanese’s VitalDose^® EVA drug delivery platform can help reduce intraocular pressure by creating a desired therapeutic release profile.

NOVELIA^®: A CLEAR VISION FOR EYE CARE FOR PATIENTS GLOBALLY

Zoë Davidson discusses the benefits of Novelia^®, Nemera’s alternative to sterile filters for multidose eye droppers for preservative-free formulations.

OPTIMISING MICROLITRE DOSING: CASE STUDY WITH INTRAVITREAL INJECTION

Terumo Medical Care Solutions

OPTIMISING MICROLITRE DOSING: CASE STUDY WITH INTRAVITREAL INJECTION

Yuki Takeuchi and Richard Whelton discuss the challenges of delivering intravitreal injections and how the combination of Terumo’s PLAJEX™ prefillable syringes with Congruence’s Microlitre Dosing Syringe system is able to address them.

OVERCOMING CHALLENGES WHEN DEVELOPING OLIGONUCLEOTIDES FOR OPHTHALMIC DRUGS

OVERCOMING CHALLENGES WHEN DEVELOPING OLIGONUCLEOTIDES FOR OPHTHALMIC DRUGS

Shiyan Chen and Binbin Tian discuss the use of oligonucleotides for ophthalmic applications, including their potential uses, advantages, challenges and difficulties when it comes to pharmacokinetic and drug metabolism studies.

INTRAVITREAL INJECTIONS – MORE THAN MEETS THE EYE: A TECHNICAL VIEW OF PRODUCT USE

Dr Andrea Allmendinger

INTRAVITREAL INJECTIONS – MORE THAN MEETS THE EYE: A TECHNICAL VIEW OF PRODUCT USE

Andrea Allmendinger and Hanns-Christian Mahler highlight the technical challenges of intravitreal administration and considerations from the ophthalmologist’s and patient’s perspectives.

GROUNDBREAKING TREND FOR PRESERVATIVE-FREE MULTIDOSE EYE DROPS IN THE US

GROUNDBREAKING TREND FOR PRESERVATIVE-FREE MULTIDOSE EYE DROPS IN THE US

Rouven Kraus discusses the increasing trend towards preservative-free formulations in ophthalmic drug delivery and the challenges presented by regulatory demands on new drug products in the space.

MISTGO<sup>®</sup> – A NEW MICRODOSING EYE MEDICATION DELIVERY SYSTEM

MISTGO^® – A NEW MICRODOSING EYE MEDICATION DELIVERY SYSTEM

Rie Saabye and Morten Jacobsen discuss the benefits of a new microdosing eye medication delivery system for chronic ophthalmic diseases, such as dry eye disease and glaucoma.

TOPICAL DRUG ADMINISTRATION FOR THE POSTERIOR SEGMENT

Dr David Bingaman

TOPICAL DRUG ADMINISTRATION FOR THE POSTERIOR SEGMENT

David Bingaman explores the potential benefits of topical administration for diseases affecting the posterior segment of the eye.

BEYOND THE EYEDROPPER BOTTLE – THREE WAYS TO IMPROVE ADHERENCE

Dr Nathan Wilkinson

BEYOND THE EYEDROPPER BOTTLE – THREE WAYS TO IMPROVE ADHERENCE

Nathan Wilkinson, Catherine Wyman and Matt Parker discuss the future outlook of ophthalmic drug delivery beyond the traditional eyedropper bottle, including new delivery technologies, sustained-release therapeutics and digital healthcare applications.

A SIGHT FOR SORE EYES: CHALLENGES & INNOVATIONS IN OPHTHALMIC DRUG DELIVERY

Dr Ethan Miller

A SIGHT FOR SORE EYES: CHALLENGES & INNOVATIONS IN OPHTHALMIC DRUG DELIVERY

Ethan Miller and Kristien De Clercq discuss recent advancements and current challenges in the field of ophthalmology, including the trend towards preservative-free multidose delivery systems, delivering smaller topical volumes with increased drug efficacy, slow-release injections for delivery to the posterior of the eye and the exciting field of gene therapy.

SILICONE-OIL-FREE PREFILLED SYRINGE SYSTEMS – GUIDANCE FOR SELECTING THE APPROPRIATE PACKAGING MATERIALS AND FOR SILICONISATION

PREFILLED SYRINGES

SILICONE-OIL-FREE PREFILLED SYRINGE SYSTEMS – GUIDANCE FOR SELECTING THE APPROPRIATE PACKAGING MATERIALS AND FOR SILICONISATION

Bernd Zeiss addresses the influence of silicone oil on syringe systems and highlights the advantages and possibilities of novel silicone-oil-free prefillable syringes, both for glass and for plastic syringes.

ANTICIPATING & MITIGATING CHALLENGES IN THE COMMERCIALISATION OF PREFILLED SYRINGES & INJECTION DEVICES – A TECHNICAL DRUG PRODUCT PERSPECTIVE

PREFILLED SYRINGES

Dr Andrea Allmendinger

ANTICIPATING & MITIGATING CHALLENGES IN THE COMMERCIALISATION OF PREFILLED SYRINGES & INJECTION DEVICES – A TECHNICAL DRUG PRODUCT PERSPECTIVE

Andrea Allmendinger and Hanns-Christian Mahler both at ten23 health, provide an insight into the challenges of integrated development of drug product and device design and fill-finish manufacturing operations.

SUSTAINABILITY MEASURES ARE THE KEY TO MEETING ESG COMMITMENTS

Matthias Birkhoff

SUSTAINABILITY MEASURES ARE THE KEY TO MEETING ESG COMMITMENTS

Matthias Birkhoff and Christophe Marie discuss the advances Aptar Pharma has made in delivering on its sustainability objectives.

DISSECTING THE DELICATE DELIVERY PROCESS FOR OCULAR GENE THERAPY

Dr Yongdong Zhou

DISSECTING THE DELICATE DELIVERY PROCESS FOR OCULAR GENE THERAPY

Yongdong Zhou considers the challenges of ocular gene therapy delivery approaches.

WHY GENE THERAPY IS PERFECT FOR TREATING OCULAR DISEASES

Dr Yongdong Zhou

WHY GENE THERAPY IS PERFECT FOR TREATING OCULAR DISEASES

Yongdong Zhou discusses the applications, advantages and challenges of gene therapy in the ophthalmic sector.

INTERVIEW: Natalia Servol, Unither Pharmaceuticals

Unither Pharmaceuticals

INTERVIEW: Natalia Servol, Unither Pharmaceuticals

In this interview, Natalia Servol, Head of Unither Pharmaceuticals’ Ophthalmic Business, speaks about the company's equipment for compounding and fill-finish of preservative-free products into multidose bottles, part of Unither’s unique and innovative preservative-free multidose offering for partners.

THE DEMAND FOR METERED DOSE EYE DROPS: A DOSE DELIVERY STUDY

THE DEMAND FOR METERED DOSE EYE DROPS: A DOSE DELIVERY STUDY

Rouven Kraus discusses a dose delivery study comparing various delivery technologies designed to meet the demand for metered dose eye drops.

A CULTURE OF COLLABORATION INSPIRES INNOVATION AND LIFE-CHANGING THERAPIES

Justin Westendorf

Phillips-Medisize

A CULTURE OF COLLABORATION INSPIRES INNOVATION AND LIFE-CHANGING THERAPIES

Justin Westendorf describes the company’s collaborative approach with a leader in ocular disease treatments to overcome technical and stakeholder challenges.

AN EYE ON THE FUTURE OF PRESERVATIVE-FREE DROPS

Alexandra Ritter

AN EYE ON THE FUTURE OF PRESERVATIVE-FREE DROPS

Alexandra Ritter and Matthias Birkhoff discuss the importance of the regulatory support the company offers to its customers for preservative-free ophthalmic platforms in the face of increasingly stringent regulatory requirements from both the EU EMA and US FDA, and describe new opportunities and growing demand for a wider range of multidose preservative-free ophthalmic drug-device combinations, including for indications such as dry-eye and glaucoma.

SUSTAINED, CONTROLLED DRUG DELIVERY TO THE EYE

SUSTAINED, CONTROLLED DRUG DELIVERY TO THE EYE

Harsh Patel, Cyonna Holmes and Brian Wilson consider the challenges and advances in sustained-release ocular drug delivery.

A NEW PLATFORM FOR SUPRACHOROIDAL DRUG DELIVERY USING STANDARD NEEDLES

Timo Kangastupa

A NEW PLATFORM FOR SUPRACHOROIDAL DRUG DELIVERY USING STANDARD NEEDLES

Timo Kangastupa discusses the potential of the suprachoroidal space for highly effective, specifically targeted drug delivery to the choroid and retina, and how Visionisti’s technology simplifies and standardises the procedure, enabling the use of standard commercially available needles for suprachoroidal delivery.

HOW TEN23 HEALTH IS MEETING DEVELOPMENTAL CHALLENGES FOR INTRAVITREAL PRODUCTS

Dr Andrea Allmendinger

HOW TEN23 HEALTH IS MEETING DEVELOPMENTAL CHALLENGES FOR INTRAVITREAL PRODUCTS

Andrea Allmendinger and Hanns-Christian Mahler highlight new regulatory and quality requirements for intravitreal applications and discuss technical challenges during drug product technical development and manufacturing.

PHARMACOKINETIC MODELS: INDISPENSABLE TOOLS FOR OPHTHALMIC DRUG DEVELOPMENT

Dr Eva M del Amo

University of Eastern Finland DrugTech

PHARMACOKINETIC MODELS: INDISPENSABLE TOOLS FOR OPHTHALMIC DRUG DEVELOPMENT

Eva del Amo presents an overview of pharmacokinetic models for ophthalmic drugs, and discusses the value of these models for future drug development in the sector.

ENVISIONING NEW HORIZONS IN OCULAR DRUG DELIVERY

ENVISIONING NEW HORIZONS IN OCULAR DRUG DELIVERY

Jay S Duker discusses the history and future of ocular drug delivery, with a special focus on posterior segment diseases and the battle to overcome significant patient and caregiver burdens.

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.

KEEPING UP WITH THE DEMAND FOR EFFECTIVE OPHTHALMIC DRUGS

KEEPING UP WITH THE DEMAND FOR EFFECTIVE OPHTHALMIC DRUGS

Robert Lee explores the growth of the ophthalmic drug market and discuss the challenges that pharma companies may face when creating drugs to treat some of the most common ocular indications.

EIGHT ESSENTIAL SUSTAINABILITY TERMS FOR THE MEDICAL DEVICE INDUSTRY

EIGHT ESSENTIAL SUSTAINABILITY TERMS FOR THE MEDICAL DEVICE INDUSTRY

Charlie Dean, Kay Sinclair and Brennan Miles provide an overview of eight terms key to a common understanding in the ongoing, and crucial, discussion surrounding sustainability.

OVERCOMING DEVELOPMENT OBSTACLES TO THE DELIVERY OF EFFECTIVE OCULAR THERAPY

OVERCOMING DEVELOPMENT OBSTACLES TO THE DELIVERY OF EFFECTIVE OCULAR THERAPY

Robert Lee discusses the growth of the ocular drug delivery market, the challenges formulators face in developing novel ocular technologies, and the role contract development and manufacturing organisations have to play in this growing market segment.

OPHTHALMIC DRUGS: PATHWAY TO OVERCOME PRIMARY PACKAGING AND DRUG PRODUCT MANUFACTURING CHALLENGES

Rainer Glockler

OPHTHALMIC DRUGS: PATHWAY TO OVERCOME PRIMARY PACKAGING AND DRUG PRODUCT MANUFACTURING CHALLENGES

Rainer Glöckler, Carole Delauney, Dr Nicolas Eon and Katsuyuki Takeuchi discuss the myriad complexities of developing drug products for intravitreal injection, and how the partnership between swissfillon and Terumo can ease and accelerate these products to market. The first article, published in April, covered how swissfillon’s state-of-the-art filling line meets the complex requirements of ophthalmic drug products.

CONSIDERATIONS FOR OPHTHALMIC DRUG DELIVERY AND DEVELOPMENT

CONSIDERATIONS FOR OPHTHALMIC DRUG DELIVERY AND DEVELOPMENT

Robert Lee discusses recent advances in ophthalmic dosage forms and how companies are meeting these challenges to better serve their customers.

STATE-OF-THE-ART SOLUTIONS FOR OPHTHALMIC STERILE DRUG PRODUCT MANUFACTURING

Rainer Glockler

STATE-OF-THE-ART SOLUTIONS FOR OPHTHALMIC STERILE DRUG PRODUCT MANUFACTURING

In the first in a series of two articles, Rainer Glöckler and Carole Delauney discuss how the company’s state-of-the-art filling line meets the requirements and complexities that are particular to ophthalmic drug product manufacturing. The second article, to be published in May, will explore partnerships between pharma, CDMOs and syringe manufacturers in more detail.

THE PIVOTAL ROLE PLAYED BY DEVICE DEVELOPERS TO IMPROVE PATIENT EYE CARE

THE PIVOTAL ROLE PLAYED BY DEVICE DEVELOPERS TO IMPROVE PATIENT EYE CARE

Zoë Davidson and Carolyn Rose discuss the challenges glaucoma and dry eye patients face with eye drop administration and present the Novelia^® system featuring patented PureFlow^® technology, which controls the medication flow.

DRUG DELIVERY TO THE EYE: OVERCOMING THE CHALLENGES OF INTRAVITREAL PREFILLED SYRINGES

Dr Suresh Gupta

DRUG DELIVERY TO THE EYE: OVERCOMING THE CHALLENGES OF INTRAVITREAL PREFILLED SYRINGES

Suresh Gupta discusses the challenges of developing a PFS product for intravitreal injection, highlighting how designing for the intravitreal space, rather than the standard parenteral, imposes a number of additional requirements on the design.

INTERVIEW WITH SAI SHANKAR, ADAM SHAIN & MARCUS BATES

INTERVIEW WITH SAI SHANKAR, ADAM SHAIN & MARCUS BATES

Sai Shankar, Adam Shain and Marcus Bates discuss the full potential of connectivity, coronavirus as a potential accelerator of adoption, and the place of connected drug delivery systems within Aptar Pharma’s broader offering to industry.

EU MDR DEADLINE DELAY: WHAT DOES IT MEAN FOR THE MEDICAL DEVICE INDUSTRY?

EU MDR DEADLINE DELAY: WHAT DOES IT MEAN FOR THE MEDICAL DEVICE INDUSTRY?

With the compliance deadline for the EU Medical Device Regulation recently delayed by a year due to the novel coronavirus pandemic, Beth Crandall looks at what it means for the medical device industry.

INTERVIEW WITH DR SRI MUDUMBA, SANTEN & DR GAUTAM SHETTY, CONGRUENCE

Dr Gautam N Shetty

Congruence Medical Solutions

INTERVIEW WITH DR SRI MUDUMBA, SANTEN & DR GAUTAM SHETTY, CONGRUENCE

In this interview, Dr Sri Mudumba, Santen, and Dr Gautam N Shetty, Congruence Medical Solutions, share insights from their experience of working together in developing the MDS for ophthalmic injections.

OPTIMISING OPHTHALMIC DRUG DELIVERY FOR THERAPEUTIC EFFECTIVENESS

Dr Barbara Morgan

OPTIMISING OPHTHALMIC DRUG DELIVERY FOR THERAPEUTIC EFFECTIVENESS

Barbara Morgan discusses how eye physiology impacts product formulation and choice of dosage form, and how advanced delivery technologies are providing new options for formulators seeking to improve the bioavailability or stability of their ophthalmic treatments.

DEVELOPING AN EFFICIENT OPHTHALMIC DEVICE COMBINATION PRODUCT

DEVELOPING AN EFFICIENT OPHTHALMIC DEVICE COMBINATION PRODUCT

Zoë Davidson looks at how understanding the patient journey can help develop an efficient ophthalmic device combination product.

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