INDUSTRIALISING DRUG DELIVERY89

Issue No #89 August 13th, 2018

Inside the magazine

ORAL THIN FILMS: NOVEL TECHNOLOGY & ITS CHALLENGES

Dr Nidhi Prakash Sapkal

ORAL THIN FILMS: NOVEL TECHNOLOGY & ITS CHALLENGES

Presented from both the technology and formulation perspectives, Nidhi Prakash Sapkal and Anwar Siraj Daud discuss the challenges of industrialising oral thin films, a promising but difficult dosage form.

BEYOND MANUFACTURING: INDUSTRIALISATION OF DRUG DELIVERY IN THE REAL WORLD

Napoleon Monroe

BEYOND MANUFACTURING: INDUSTRIALISATION OF DRUG DELIVERY IN THE REAL WORLD

When discussing the industrialisation of drug delivery, it is natural to focus on the processes and management of manufacture. Napoleon Monroe provides a different perspective on the idea of drug delivery’s “Industrialisation” and what that might mean in the modern world of service industry.

INDUSTRIALISING DRUG DELIVERY SYSTEMS – A RISK-BASED APPROACH

INDUSTRIALISATION

Catherine Thacker

INDUSTRIALISING DRUG DELIVERY SYSTEMS – A RISK-BASED APPROACH

Catherine Thacker and Tom Hayes discuss ATS Automation’s methodology for developing a manufacturing strategy for a drug delivery device, from fresh design to mass-produced product.

MEASURING THE INFLUENCE OF TALC ON THE PROPERTIES OF LACTOSE POWDERS

INDUSTRIALISATION

Dr Quentin Ribeyre

MEASURING THE INFLUENCE OF TALC ON THE PROPERTIES OF LACTOSE POWDERS

Quentin Ribeyre et al describe how three of the company’s instruments can be used to characterise powder properties and behaviour, exemplified by experiments investigating the effects of adding talc to different lactose grades.

THE BIGGEST MISTAKES COMPANIES MAKE COMMERCIALISING DRUG DELIVERY – AND WHAT TO DO ABOUT THEM

THE BIGGEST MISTAKES COMPANIES MAKE COMMERCIALISING DRUG DELIVERY – AND WHAT TO DO ABOUT THEM

It is difficult to successfully scale-up a product to industrial production and launch, but it is much harder if design fundamentals are not adhered to. Beth Blackburn details the need for setting down requirements early in device development in order to avoid inadvertently undermining a product’s successful commercialisation.

A “KODAK” MOMENT FOR THE PHARMA INDUSTRY?

A “KODAK” MOMENT FOR THE PHARMA INDUSTRY?

Pari Datta and Nick Rollings discuss the concept of personalised medicine, with particular reference to oncology, and how it represents both an opportunity and a threat.

A COMPREHENSIVE APPROACH TO PHARMA INDUSTRIALISATION PARTNERING

INDUSTRIALISATION

Michael Wiglenda

A COMPREHENSIVE APPROACH TO PHARMA INDUSTRIALISATION PARTNERING

As a company offering contract services at every stage of drug delivery system development, Gerresheimer has a wealth of expertise and history in industrial-scale production. Michael Wiglenda explains Gerresheimer’s industrialisation offering in detail.

KEY CONSIDERATIONS FOR ACCURATE QUANTIFICATION OF SUB-MICRON PARTICLES IN PHARMACEUTICALS

INDUSTRIALISATION

Dr Jean-Luc Fraikin

KEY CONSIDERATIONS FOR ACCURATE QUANTIFICATION OF SUB-MICRON PARTICLES IN PHARMACEUTICALS

Jean-Luc Fraikin discusses the use of resistive pulse sensing as a method to characterise nanoparticles in biologic formulations. Spectradyne has developed a new implementation of this technique, MPRS, that makes it a practical analytical method for industrial pharmaceutical applications.

THE ODTECH PLATFORM: A RANGE OF READY-TO-USE ORAL FORMS

INDUSTRIALISATION

Hugues Benevent

Unither Pharmaceuticals

THE ODTECH PLATFORM: A RANGE OF READY-TO-USE ORAL FORMS

Hugues Benevent and Nathalie Masson introduce the ODtech™ platform technology for oral medications, designed to provide an easy-to-use and ready-to-industrialise solution for tackling the human factors issues of standard oral pills.

MANAGING RISKS & COSTS FOR SEAMLESS SCALE-UP & SMOOTH COMMERCIALISATION

INDUSTRIALISATION

Simon Strothers

MANAGING RISKS & COSTS FOR SEAMLESS SCALE-UP & SMOOTH COMMERCIALISATION

Today’s drug delivery industry is seeing shifting thought in a number of areas, one of which is the move towards design for manufacture. Simon Strothers and Dave Seaward both of 3P innovation, discuss a “better way” for developing drug delivery devices, highlighting design for manufacture, critical quality concerns and mandraulic prototyping.

INTEGRATING CONNECTED HEALTH IN RESPIRATORY: THE MANUFACTURING CHALLENGE

INTEGRATING CONNECTED HEALTH IN RESPIRATORY: THE MANUFACTURING CHALLENGE

David Belton highlights an often undiscussed aspect of the move towards connected drug delivery devices, the impact on manufacturing. Using inhalers as a reference point, he runs through several of the concerns and decisions that will need to be addressed for successful mass production of such devices.

THE NEED FOR A RELIABLE SUPPLY-CHAIN & HOW TO CREATE IT STRATEGICALLY

THE NEED FOR A RELIABLE SUPPLY-CHAIN & HOW TO CREATE IT STRATEGICALLY

Antonio Teglia and Devon McCrossin discuss the increased importance of proper supply-chain management when it comes to mitigating the inherent production risks of today’s increasingly complex drug delivery devices.

ELECTROSPINNING: A PROMISING APPROACH TO CONTINUOUS MANUFACTURING FOR PHARMACEUTICALS

Dr Blair Brettmann

Georgia Institute of Technology

ELECTROSPINNING: A PROMISING APPROACH TO CONTINUOUS MANUFACTURING FOR PHARMACEUTICALS

Blair Brettmann discusses the present advantages and challenges, as well as the future potential, of electrospinning as a continuous manufacturing technique for the pharmaceutical industry.

TORSTEN MASCHKE, DATWYLER SEATLING SOLUTIONS

Torsten Maschke

TORSTEN MASCHKE, DATWYLER SEATLING SOLUTIONS

Torsten Maschke discusses the industrialisation of drug delivery, from the perspective of an industrialisation specialist partner for the pharmaceutical industry, looking at the trends in the field today and the advantages of the modern paradigm of partnering.

GO WITH THE FLOW – SOLVING POWDER FLOW CHALLENGES BEFORE PRODUCTION

GO WITH THE FLOW – SOLVING POWDER FLOW CHALLENGES BEFORE PRODUCTION

Jonathan Gaik discusses the various problems in tablet compression that can be caused by not giving due care to powder flow in the development stage and how, by doing so, what would be serious problems at the industrial scale can be solved in advance.

GAS PLASMA PROCESSING: A LONG-TERM SOLUTION FOR RESPIRATORY DEVICES

INDUSTRIALISATION

GAS PLASMA PROCESSING: A LONG-TERM SOLUTION FOR RESPIRATORY DEVICES

Ameet Sule, Head of H&T Presspart’s Inhalation Product Technology Centre (IPCT), discusses the new challenges arising in metered dose inhaler design since the change from CFC to HFA propellants.

DEVICE MANUFACTURING FROM DEVELOPMENT THROUGH COMMERCIALISATION

INDUSTRIALISATION

Sheleagh Dougan

DEVICE MANUFACTURING FROM DEVELOPMENT THROUGH COMMERCIALISATION

Sheleagh Dougan and Meredith Canty give an overview of the scales of manufacturing throughout the design of a new combination product and the necessary considerations at each one.

THE CHALLENGES OF MANUFACTURING COMBINATION COMPONENTS

INDUSTRIALISATION

THE CHALLENGES OF MANUFACTURING COMBINATION COMPONENTS

Bob Parsons and Jim Arps discuss three significant challenges faced by companies looking to manufacture components for combination products in the medical sector and how ProMed has risen to meet them.