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May 12, 2010
Innovative but Practical Technologies to Tame Difficult APIs for Formulation Development & GMP Manufacture
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SPEAKERS FOR THIS EVENT: 
Emma Mickley, Ph.D., Director of Business Development, R5 Pharmaceuticals 
Richard Johnson, Ph.D., Managing Director, Upperton Limited
Marcel de Matas, Ph.D., Scientific Manager, Lena Nanoceutics
Steffen Mittwich, Dipl. Wi.-Ing., CEO, Atacama Labs
Rob Lammens, Ph.D., CTO, Atacama Labs |
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Innovative but Practical Technologies to Tame Difficult APIs for Formulation Development & GMP Manufacture 
Biopharmaceuticals are becoming more complex and, by association, the physical characteristics are becoming more challenging, leading to the need for more careful handling and processing. This talk will introduce 3 new technologies which could revolutionize the formulation world and how you approach your product's development and life-cycle management. R5 Pharmaceuticals will introduce some of the challenges faced and innovative, but practical, technologies that can help. All of these technologies are available both for developmental and GMP phases of therapeutic development. The technologies we will be introducing are:
Dr. Richard Johnson – Upperton Limited
Pharmaceutical Spray Drying: Research, Development and Clinical Trials Manufacture
Spray-drying is a cost-effective alternative to Freeze-Drying. The technology has a number of applications.
This presentation will focus on:
• How the technology works
• Early R&D formulation with the technology
• Clinical trial manufacture
• Uses of the technology e.g. in controlled release therapies, to enhance stability
Dr. Marcel de Matas – Lena Nanoceutics
Nanomilling: Innovative Nanoparticle Formulation Development: Overcoming drug solubility challenges
Nanomilling produces homogenous, nano-particle sizes to improve processing and to enhance bioavailability.
This presentation will focus on:
• Capability for rapid nanoparticle generation of APIs
• Dealing with challenging mechanical properties
• Production of nanoparticulate formulations with suitable physical and chemical stability
• Methods for isolation of nanoparticulate formulations in solid form with suitable characteristics for tabletting
• Improved dissolution kinetics and in vivo bioavailability approaches
Mr. Steffen Mittwich & Dr. Rob Lammens - Atacama Labs
Pneumatic Dry Granulation: A dry process to improve oral formulation design time and resource requirements
PDG technology creates porous granules increasing options, including compression characteristics.
This presentation will focus on:
· PDG Technology - commercial and technical advantages
· PDG-0260 equipment and its technology in detail
· PDG Technology in detail for galenic developers and production heads
· PDG granules: scientific data and study results
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| THIS PROGRAM IS INTENDED FOR: |
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Formulation development, Pharmaceutical Sciences, CMC personnel at Biopharmaceutical companies in the following stages:
· Early development
· Preclinical development
· Early Clinical Trial development
· Marketed Products, working on Product Life-cycle strategies
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Emma Mickley, Ph.D., Director of Business Development, R5 Pharmaceuticals
Emma is the Director of BD at R5 Pharmaceuticals, joining the company in November 2009. Prior to her role at R5, Emma specialised in preclinical biopharmaceutical development including discovery and regulatory toxicology, ADME and safety pharmacology with positions at CXR Biosciences, Charles River Laboratories and Quintiles. Emma also worked at the consultancy firm, Wood Mackenzie, as an analyst in Pharmaceuticals and Biotechnology team. She gained her PhD from the Department of Medicine, University of Edinburgh and her First Class Honours degree in Pharmacology from Kings College, University of London.
R5 Pharmaceuticals Ltd is a formulation development and clinical trial supply manufacturing expert conducting contract services to the biopharmaceutical industry. R5 is steeped in industry experience and offer most dosage form development (oral, inhaled, parenteral) and Phase I and 2 clinical trial manufacture. R5 is licensed by MHRA for GMP manufacture and testing of Investigational Medicial Products and Specials. We work with the technology companies described below, providing GMP capabilities and QP release. |
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Richard Johnson, Ph.D., Managing Director, Upperton Limited
Richard trained as a biochemist and gained his PhDfrom Warwick University before joining Delta Biotechnology (UK) in 1986 as a protein chemist. After leaving Delta in 1994, Richard co-founded Andaris Ltd, a drug delivery company specialising in spray drying and microencapsulation. When Andaris was acquired by Quadrant Healthcare, he founded Upperton Limited in 1999 and is currently the Managing Director of the company.
Upperton Ltd is a privately owned company that specialises in the development of novel micro and nanoparticles for the pharmaceutical and biotechnology industries. Its core technologies include specialised spray drying processes that can be applied to customers' products to enhance their delivery and performance.
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Marcel de Matas, Ph.D., Scientific Manager, Lena Nanoceutics
Marcel has led the establishment of Lena’s technology for production of nanoparticulate formulations for enhanced drug delivery. He has responsibility for product development, project delivery and driving the science agenda within Lena, whilst also managing programmes for future advancement of the technology. Following attainment of his degree in Chemistry and PhD in physical pharmaceutics, Marcel has spent much of his career in industry, latterly at AstraZeneca where he led pharmaceutical development teams supporting clinical development and commercialisation of candidate drugs. In addition to his company commitments, Marcel is also a Senior Lecturer in Clinical Pharmaceutics in the School of Pharmacy at Bradford, where he leads research programmes to evaluate new delivery systems for improved oral, parenteral and respiratory drug delivery.
Lena Nanoceutics Ltd is a technology company which provides enhanced nanoparticle based formulations, addressing issues such as poor bioavailability, for pharmaceutical and healthcare products. This is achieved through the application of its efficient proprietary particle size reduction system together with significant expertise in formulation and drug delivery. Lena Nanoceutics’ strategy focuses on collaboration with clients to develop innovative solutions that are readily scalable to production levels. |
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Steffen Mittwich, Dpli. Wi.-Ing., CEO, Atacama Labs
Steffen Mittwich has worked in the pharmaceutical industry since 1992 and has held several management positions in sales and marketing within major European and international pharmaceutical companies, such as sanofi-aventis, Novartis and Pfizer. His latest position at sanofi-aventis was Regional Business Director in Switzerland and CEO of Winthrop Pharmaceuticals.
Steffen Mittwich is Industrial Economics Engineer from the Technical University of Karlsruhe, Germany. |
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Rob Lammens, Ph.D., CTO, Atacama Labs
Dr. Lammens studied Physical Chemistry at the University of Utrecht and performed his PhD at the department of Pharmaceutical Technology (University of Leiden), before joining the Pharmaceutical Technology Department of Bayer AG at Leverkusen in 1981, which company he left in 2004. Since 2001 he is a lecturer in Pharmaceutical Technology of the University of Bonn and is running the company Technical Services Consult Lammens. Both at Bayer and at the University he has been and is still working mainly in the field of solid dosage forms formulation, especially scale up projects and the development and improvement of manufacturing equipment.
Atacama Laboratories OY is a technology company that offers added value to pharmaceutical and generic companies by differentiating and improving their existing product portfolios with the PDG TechnologyTM(PDG).
Atacama Laboratories OY is a technology company that offers added value to pharmaceutical and generic companies by differentiating and improving their existing product portfolios with the PDG TechnologyTM(PDG). Atacama offers the industry a faster galenic development process, improved and easier formulations and highly reliable and efficient contract production in terms of input / output ratio. PDG can process almost any kind of API including difficult substances. It highly efficient for oral dissolving tablets due to the innovative granules provided. The technology is optimal for reducing tablet size via increased drugload thereby increasing patient compliance and affording highly suitable platform for fixed combinations. |
| ABOUT OUR SPONSORING PARTNER: |
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R5 Pharmaceuticals Ltd is a formulation development and clinical trial supply manufacturing expert conducting contract services to the biopharmaceutical industry. R5 is steeped in industry experience and offer most dosage form development (oral, inhaled, parenteral) and Phase I and 2 clinical trial manufacture. R5 is licensed by MHRA for GMP manufacture and testing of Investigational Medicial Products and Specials. We work with the technology companies described below, providing GMP capabilities and QP release. |
For information about the recorded archive for this event contact Xtalks at (416) 977-6555 ext 371, or email register@xtalks.com |