newsletter 1

4
www.tillotts.com Welcome to the first edition of our quarterly newsletter which we have launched in order to provide you with our latest news and developments within Contract Research, Drug Delivery and Contract Manufacturing at Tillotts Services. Following the acquisition of Tillotts Pharma AG by Zeria Pharmaceutical Co., Ltd. in September 2009, the decision was made to expand our already successful contract manufacturing business and introduce contract R&D in order to better serve the needs of our customers. A strategic review of our business in early 2010 and the recruitment of new staff, was followed by the European launch of Tillotts Services at CPhI in Paris in October 2010. Our North American launch was next at AAPS in New Orleans during November. As an innovator in gastro-intestinal (GI) therapies and associated drug delivery technologies, we believe that Tillotts Services can add value through our established capabilities in solving difficult formulation challenges for our pharmaceutical and biotechnology customers. A key element of our strategy is to align our resources to the needs of our customers. Our new strap-line, captures both our expertise in liquid-fill encapsulation with our strategy to innovate in enabling drug delivery technologies and in doing so provide differentiation. We aim to be unique in terms of both capability and service to our customers. Many large multinationals such as J&J, Pfizer, GSK and Teva already trust Tillotts Services for their commercial drug product supply. Our strategy to integrate a new contract research capability represented a natural progression, we have further built upon this through investing in pioneering drug delivery research. Being part of the global Zeria organisation means that our customers are dealing with a financially secure and stable partner throughout the development process and life-cycle of their drug product. Issue 1 Analytical/QC Regulatory Support Pre-formulation Development Formulation Development Clinical Supply : PI, II & III Poorly Soluble API’s Pre- and Probiotics High Potency Drugs Oral Drug Delivery Gastro Intestinal Liquid-Fill Manufacturing Contract Research Core Competencies Capabilities Product Focus Areas Capability Platform Tillotts Services Expanding a Quality and Reliable Service into a New Brand.... we encapsulate innovation Tillotts Services A new Global CRO/CMO Service concept... Contract Research Contract Manufacturing Packaging Process Development Pre-formulation Development Logistics Process Validation Project Management Formulation Development Clinical Supply (Phase I to IV) Analytical Chemistry, QC, QA, QP & Regulatory Support NEWSLETTER

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Tillotts Services Newsletter Issue 1

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Page 1: Newsletter 1

11 Apr, 2011 - 13 Apr, 2011Global Pre-Formulation and Formulation summitAmsterdam, Netherlands

To be held at Mercure Hotel Amsterdam Aan de Amstel, The Netherlands

For more information please visit:www.pharmaceuticalpreformulation.com

10 May, 2011 - 11 May, 2011Delivering a potent and high potent API manufacturing and handling strategiesMunich, Germany

Dr Joe Carey will be presenting a paper entitled “Establishing a High Potent development capability in liquid-fill encapsulation”

For more information please visit:www.nextlevelpharma.com

12th MayPharmaTrans Scientific & Technical Forum Basel, Switzerland

The PharmaTrans 8th Scientific & Technical Forum on “Innovative Drug Delivery Systems“ will be held in Basel on 12th May, please come and visit us at our exhibition stand.

For more information please visit:http://www.pharmatrans-sanaq.com/Forum2011.html

www.tillotts.com

Welcome to the first edition of our quarterly newsletter which we have launched in order to provide you with our latest news and developments within Contract Research, Drug Delivery and Contract Manufacturing at Tillotts Services.

Following the acquisition of Tillotts Pharma AG by Zeria Pharmaceutical Co., Ltd. in September 2009, the decision was made to expand our already successful contract manufacturing business and introduce contract R&D in order to better serve the needs of our customers.

A strategic review of our business in early 2010 and the recruitment of new staff, was followed by the European launch of Tillotts Services at CPhI in Paris in October 2010. Our North American launch was next at AAPS in New Orleans during November.

As an innovator in gastro-intestinal (GI) therapies and associated drug delivery technologies, we believe that Tillotts Services can add value through our established capabilities in solving difficult formulation challenges for our pharmaceutical and biotechnology customers. A key element of our strategy is to align our resources to the needs of our customers.

Our new strap-line,

captures both our expertise in liquid-fill encapsulation with our strategy to innovate in enabling drug delivery technologies and in doing so provide differentiation. We aim to be unique in terms of both capability and service to our customers.

Many large multinationals such as J&J, Pfizer, GSK and Teva already trust Tillotts Services for their commercial drug product supply. Our strategy to integrate a new contract research capability represented a natural progression, we have further built upon this through investing in pioneering drug delivery research. Being part of the global Zeria organisation means that our customers are dealing with a financially secure and stable partner throughout the development process and life-cycle of their drug product.

Issue 1

Analytical/QC

Regulatory Support

Pre-formulation Development

Formulation Development

Clinical Supply : PI, II & III

Poorly Soluble API’s

Pre- and Probiotics

High Potency Drugs

Oral Drug Delivery

Gastro IntestinalLiquid-Fill

Manufacturing

Contract Research

Core Competencies CapabilitiesProduct Focus Areas

Capability Platform

Tillotts Services Expanding a Quality and Reliable Service into a New Brand....

we encapsulate innovation

Tillotts Services A new Global CRO/CMO Service concept...

Contract Research

Contract Manufacturing

Packaging

ProcessDevelopment

Pre-formulationDevelopment

Logistics

ProcessValidation

ProjectManagement

FormulationDevelopment

Clinical Supply(Phase I to IV)

Analytical Chemistry,QC, QA, QP &

Regulatory Support

NEWSLETTER

Acknowledgements: Photography by Gary Baker Photography. Design by David Anthony, AK Design (Scotland) Ltd.

For more information, please contact us at:

Putting a name to a face So who is behind our new brand?...

Q: So Kanda please tell us a little about yourself:

A: I am originally from Thailand and joined Tillotts three years ago. I live with my husband in Lausen which is in the Canton of Baselland, so the drive to work is not too long.

Q: Please describe your role within Tillotts Services:

A: I work within the Production Team, my role involves visual inspection, sorting and bulk packaging of our liquid filled hard gelatin capsules.

Q: So how do you feel about the new marketing material?

A: I am very proud that a picture of me was chosen for the new branding. From my perspective, this branding reflects our quality.

Q: So what is it like working at Tillotts?A: We have a very good and warm working atmosphere with a lot of very nice and friendly colleagues and this is always an important aspect of work.

As part of our launch we engaged the photographic services of Gary Baker from Scotland. Gary had a simple brief which was to capture the key elements of our business; our people and our products. Snapping away around our production area he captured a number of excellent pictures including one that is now our brand.

The picture is of Kanda Nägelin who is one of our hardworking production staff. Claudio Scialdone who manages our manufacturing services, caught up with Kanda and found out a little more...

ww

w.tillotts.com T: +41 61 935 28 28

F: +41 61 935 28 29E: [email protected]

Tillotts Pharma AGTillotts ServicesHauptstrasse 274417 ZiefenSwitzerland

Tillotts Services will be represented at the following events during 2011. We would be delighted to meet with you.

Let’s Have Coffee...

Page 2: Newsletter 1

New Frontiers Focus on TechnologyTillotts Services is now an integrated CRO and CMO, with a global reach that has a portfolio of technologies focused on liquid-fill encapsulation using two-piece, hard-shell capsules. Our strategy is to offer our customers a different experience when outsourcing their New Chemical Entity (NCE), clinical supply or commercial drug product supply.

Tillotts Services was launched at the American Association of Pharmaceutical Sciences (AAPS) conference and exhibition in New Orleans last November. The North American market represents new territory for us and we were delighted at the interest from the pharmaceutical and biotech companies that we met.

North America Launch AAPS in New Orleans

We are delighted to announce a research and development collaboration with Professor Dr.

Martin Kuentz and the University of Applied Sciences Northwestern Switzerland in the field of oral lipid based suspensions and Quality by Design (QbD). Professor Kuentz is an internationally recognised expert in the field of pharmaceutical technology. He is head of a research group working in the areas of oral lipid based drug delivery formulations, modelling of drug absorption as well as in Quality by Design (QbD). Prof. Kuentz has published more than 40 scientific articles in high impact journals and is member of the AAPS and APV. After his degree in Pharmacy from the University of Basel, Prof. Kuentz started his industrial career at Hoffmann-La Roche in the Formulation Research and Development Team. As a Senior Scientist, Prof. Kuentz developed several oral formulations and became in 2003 the global contact person in the field of oral lipid-based drug delivery formulations. After 7 years in industry, Prof. Kuentz joined the University of Applied Sciences Northwestern Switzerland in 2006 and was appointed as Professor in 2008.

We look forward to our collaboration with Prof Kuentz and the University of Applied Sciences Northwestern Switzerland.

Forging New Academic Alliances University of Applied Sciences Northwestern Switzerland

In this edition we cover our DV-II+ PRO Digital Viscometer. We chose this instrument because of its accuracy, reliability and versatility with the advantages of continuous sensing, temperature measurement and data output to PC or printer. When controlled by PC, the DV-II+ PRO becomes a Rheometer with variable speed capability from 0.01 to 200 rpm.

Knowledge of the flowability, rheological behavior over time and the physical state of the active pharmaceutical ingredient (API) in lipid based formulations (suspension/solution) are essential factors for predicting the processability and filling behavior prior to, and during liquid-fill encapsulation. Here, the characteristics of the formulation and its structural changes during processing must be investigated and also measured. Using this knowledge a robust production process can be designed and calculations of the final filling speed can be defined.

We set tight specifications for viscosities since, with some materials these can vary dramatically due to processing and particle size distribution. In some cases we also set a specification for particle size distribution and work with API suppliers to manage this important criteria. In a general sense, when dealing with lipid based suspensions, we aim to have a well defined range of particle size distribution of the active molecule, by either working with micronized, milled or sieved solids.

When working with lipid-based formulations using excipients of high glass transition temperature (Tg) and therefore semi-solids at ambient temperature, it is crucial to evaluate the rheological properties of the formulation by drawing thermorheograms in order to

determine the most suitable filling temperature for the product during production. Thanks to the availability of the laboratory scale viscometer DV-II+ PRO Digital at Tillotts Services, the following procedure is conducted when dealing with semisolid lipid based formulations. After carefully melting the semisolid excipient by heating it up to maximally 10 to 20°C above its melting point (MP), the API is incorporated and its physical state (suspension/solution) is evaluated by microscopically imaging of the mixture. Thereafter, the filling temperature of the product is determined based on the inflection point obtained from the thermorheogram of the product.

A hypothetical representation of such a rheological analysis is show in the Figure. The common praxis is to set up the filling temperature for production

between 2 to 3°C above the temperature of inflection (T inflexion) obtained from thermorheograms. With this information in hands, the product can be filled into hard shell capsules and finally kept at room temperature to allow solidification of the semisolid mass.

For more information please visit: http://www.brookfieldengineering.com/products/viscometers/laboratory-dv-ii.asp

Within this section we aim to profile a technology area related to our business.

European Launch CPhI in ParisTillotts Services was launched at the Chemical and Pharmaceutical Intermediates (CPhI) exhibition in Paris last October which included the introduction of our new branding which is consistent with our Tillotts Pharma AG corporate style.

Our new exhibition stand and literature is now supported by a new and interactive Tillotts Services website that allows current and prospective customers to

quickly access information or request proposals and quotations for projects. We have integrated the information request forms within our new Client Relation Management (CRM) system which ensures an expedient response time and ensures we meet our customers needs.

CPhI provided the ideal launch pad for Europe, our home market. We were invited to locate within the New Exhibitor Section and were able to benefit from this location with a good throughput of exhibitor traffic over the three days. CPhI continues to grow significantly in size and content each year and the drug product and manufacturing sections have added to its success as the premier event within Europe. So see you in Frankfurt this October, and of course we will also be bringing some more Swiss chocolate! We would also like to thank our CEO for taking this photo.

For our development and production needs this instrument was preferred and other key features & benefits included:

Continuous display of: Viscosity (cP or mPa·s), Temperature (°C or °F), Shear Rate, Shear Stress, % Torque, SpindleTorque measurement accuracy: 1% of full scale rangeRepeatability: 0.2% of full scale range 54 selectable speeds provide superior range of viscosity/shear measurements for use in stand-alone operation Download custom programs with DV Loader software (included) Automate program control by PC running optional Rheocalc® software; speed control from 0.01 to 200 rpmAutomatic data collection and historical comparison with optional Wingather™ softwareBuilt-in RTD temperature probe for sample monitoring Easy-to-use keypad for simple selection of test parameters Auto-zero function to ensure precision torque measurement Customizable options Parallel printer, serial RS-232 and analog voltage outputs

Copyright © Tillotts Pharma AG 2011

VISC

OSI

TY

TEMPERATURE T in�ection

www.tillotts.com

Figure

Page 3: Newsletter 1

New Frontiers Focus on TechnologyTillotts Services is now an integrated CRO and CMO, with a global reach that has a portfolio of technologies focused on liquid-fill encapsulation using two-piece, hard-shell capsules. Our strategy is to offer our customers a different experience when outsourcing their New Chemical Entity (NCE), clinical supply or commercial drug product supply.

Tillotts Services was launched at the American Association of Pharmaceutical Sciences (AAPS) conference and exhibition in New Orleans last November. The North American market represents new territory for us and we were delighted at the interest from the pharmaceutical and biotech companies that we met.

North America Launch AAPS in New Orleans

We are delighted to announce a research and development collaboration with Professor Dr.

Martin Kuentz and the University of Applied Sciences Northwestern Switzerland in the field of oral lipid based suspensions and Quality by Design (QbD). Professor Kuentz is an internationally recognised expert in the field of pharmaceutical technology. He is head of a research group working in the areas of oral lipid based drug delivery formulations, modelling of drug absorption as well as in Quality by Design (QbD). Prof. Kuentz has published more than 40 scientific articles in high impact journals and is member of the AAPS and APV. After his degree in Pharmacy from the University of Basel, Prof. Kuentz started his industrial career at Hoffmann-La Roche in the Formulation Research and Development Team. As a Senior Scientist, Prof. Kuentz developed several oral formulations and became in 2003 the global contact person in the field of oral lipid-based drug delivery formulations. After 7 years in industry, Prof. Kuentz joined the University of Applied Sciences Northwestern Switzerland in 2006 and was appointed as Professor in 2008.

We look forward to our collaboration with Prof Kuentz and the University of Applied Sciences Northwestern Switzerland.

Forging New Academic Alliances University of Applied Sciences Northwestern Switzerland

In this edition we cover our DV-II+ PRO Digital Viscometer. We chose this instrument because of its accuracy, reliability and versatility with the advantages of continuous sensing, temperature measurement and data output to PC or printer. When controlled by PC, the DV-II+ PRO becomes a Rheometer with variable speed capability from 0.01 to 200 rpm.

Knowledge of the flowability, rheological behavior over time and the physical state of the active pharmaceutical ingredient (API) in lipid based formulations (suspension/solution) are essential factors for predicting the processability and filling behavior prior to, and during liquid-fill encapsulation. Here, the characteristics of the formulation and its structural changes during processing must be investigated and also measured. Using this knowledge a robust production process can be designed and calculations of the final filling speed can be defined.

We set tight specifications for viscosities since, with some materials these can vary dramatically due to processing and particle size distribution. In some cases we also set a specification for particle size distribution and work with API suppliers to manage this important criteria. In a general sense, when dealing with lipid based suspensions, we aim to have a well defined range of particle size distribution of the active molecule, by either working with micronized, milled or sieved solids.

When working with lipid-based formulations using excipients of high glass transition temperature (Tg) and therefore semi-solids at ambient temperature, it is crucial to evaluate the rheological properties of the formulation by drawing thermorheograms in order to

determine the most suitable filling temperature for the product during production. Thanks to the availability of the laboratory scale viscometer DV-II+ PRO Digital at Tillotts Services, the following procedure is conducted when dealing with semisolid lipid based formulations. After carefully melting the semisolid excipient by heating it up to maximally 10 to 20°C above its melting point (MP), the API is incorporated and its physical state (suspension/solution) is evaluated by microscopically imaging of the mixture. Thereafter, the filling temperature of the product is determined based on the inflection point obtained from the thermorheogram of the product.

A hypothetical representation of such a rheological analysis is show in the Figure. The common praxis is to set up the filling temperature for production

between 2 to 3°C above the temperature of inflection (T inflexion) obtained from thermorheograms. With this information in hands, the product can be filled into hard shell capsules and finally kept at room temperature to allow solidification of the semisolid mass.

For more information please visit: http://www.brookfieldengineering.com/products/viscometers/laboratory-dv-ii.asp

Within this section we aim to profile a technology area related to our business.

European Launch CPhI in ParisTillotts Services was launched at the Chemical and Pharmaceutical Intermediates (CPhI) exhibition in Paris last October which included the introduction of our new branding which is consistent with our Tillotts Pharma AG corporate style.

Our new exhibition stand and literature is now supported by a new and interactive Tillotts Services website that allows current and prospective customers to

quickly access information or request proposals and quotations for projects. We have integrated the information request forms within our new Client Relation Management (CRM) system which ensures an expedient response time and ensures we meet our customers needs.

CPhI provided the ideal launch pad for Europe, our home market. We were invited to locate within the New Exhibitor Section and were able to benefit from this location with a good throughput of exhibitor traffic over the three days. CPhI continues to grow significantly in size and content each year and the drug product and manufacturing sections have added to its success as the premier event within Europe. So see you in Frankfurt this October, and of course we will also be bringing some more Swiss chocolate! We would also like to thank our CEO for taking this photo.

For our development and production needs this instrument was preferred and other key features & benefits included:

Continuous display of: Viscosity (cP or mPa·s), Temperature (°C or °F), Shear Rate, Shear Stress, % Torque, SpindleTorque measurement accuracy: 1% of full scale rangeRepeatability: 0.2% of full scale range 54 selectable speeds provide superior range of viscosity/shear measurements for use in stand-alone operation Download custom programs with DV Loader software (included) Automate program control by PC running optional Rheocalc® software; speed control from 0.01 to 200 rpmAutomatic data collection and historical comparison with optional Wingather™ softwareBuilt-in RTD temperature probe for sample monitoring Easy-to-use keypad for simple selection of test parameters Auto-zero function to ensure precision torque measurement Customizable options Parallel printer, serial RS-232 and analog voltage outputs

Copyright © Tillotts Pharma AG 2011

VISC

OSI

TY

TEMPERATURE T in�ection

www.tillotts.com

Figure

Page 4: Newsletter 1

11 Apr, 2011 - 13 Apr, 2011Global Pre-Formulation and Formulation summitAmsterdam, Netherlands

To be held at Mercure Hotel Amsterdam Aan de Amstel, The Netherlands

For more information please visit:www.pharmaceuticalpreformulation.com

10 May, 2011 - 11 May, 2011Delivering a potent and high potent API manufacturing and handling strategiesMunich, Germany

Dr Joe Carey will be presenting a paper entitled “Establishing a High Potent development capability in liquid-fill encapsulation”

For more information please visit:www.nextlevelpharma.com

12th MayPharmaTrans Scientific & Technical Forum Basel, Switzerland

The PharmaTrans 8th Scientific & Technical Forum on “Innovative Drug Delivery Systems“ will be held in Basel on 12th May, please come and visit us at our exhibition stand.

For more information please visit:http://www.pharmatrans-sanaq.com/Forum2011.html

www.tillotts.com

Welcome to the first edition of our quarterly newsletter which we have launched in order to provide you with our latest news and developments within Contract Research, Drug Delivery and Contract Manufacturing at Tillotts Services.

Following the acquisition of Tillotts Pharma AG by Zeria Pharmaceutical Co., Ltd. in September 2009, the decision was made to expand our already successful contract manufacturing business and introduce contract R&D in order to better serve the needs of our customers.

A strategic review of our business in early 2010 and the recruitment of new staff, was followed by the European launch of Tillotts Services at CPhI in Paris in October 2010. Our North American launch was next at AAPS in New Orleans during November.

As an innovator in gastro-intestinal (GI) therapies and associated drug delivery technologies, we believe that Tillotts Services can add value through our established capabilities in solving difficult formulation challenges for our pharmaceutical and biotechnology customers. A key element of our strategy is to align our resources to the needs of our customers.

Our new strap-line,

captures both our expertise in liquid-fill encapsulation with our strategy to innovate in enabling drug delivery technologies and in doing so provide differentiation. We aim to be unique in terms of both capability and service to our customers.

Many large multinationals such as J&J, Pfizer, GSK and Teva already trust Tillotts Services for their commercial drug product supply. Our strategy to integrate a new contract research capability represented a natural progression, we have further built upon this through investing in pioneering drug delivery research. Being part of the global Zeria organisation means that our customers are dealing with a financially secure and stable partner throughout the development process and life-cycle of their drug product.

Issue 1

Analytical/QC

Regulatory Support

Pre-formulation Development

Formulation Development

Clinical Supply : PI, II & III

Poorly Soluble API’s

Pre- and Probiotics

High Potency Drugs

Oral Drug Delivery

Gastro IntestinalLiquid-Fill

Manufacturing

Contract Research

Core Competencies CapabilitiesProduct Focus Areas

Capability Platform

Tillotts Services Expanding a Quality and Reliable Service into a New Brand....

we encapsulate innovation

Tillotts Services A new Global CRO/CMO Service concept...

Contract Research

Contract Manufacturing

Packaging

ProcessDevelopment

Pre-formulationDevelopment

Logistics

ProcessValidation

ProjectManagement

FormulationDevelopment

Clinical Supply(Phase I to IV)

Analytical Chemistry,QC, QA, QP &

Regulatory Support

NEWSLETTER

Acknowledgements: Photography by Gary Baker Photography. Design by David Anthony, AK Design (Scotland) Ltd.

For more information, please contact us at:

Putting a name to a face So who is behind our new brand?...

Q: So Kanda please tell us a little about yourself:

A: I am originally from Thailand and joined Tillotts three years ago. I live with my husband in Lausen which is in the Canton of Baselland, so the drive to work is not too long.

Q: Please describe your role within Tillotts Services:

A: I work within the Production Team, my role involves visual inspection, sorting and bulk packaging of our liquid filled hard gelatin capsules.

Q: So how do you feel about the new marketing material?

A: I am very proud that a picture of me was chosen for the new branding. From my perspective, this branding reflects our quality.

Q: So what is it like working at Tillotts?A: We have a very good and warm working atmosphere with a lot of very nice and friendly colleagues and this is always an important aspect of work.

As part of our launch we engaged the photographic services of Gary Baker from Scotland. Gary had a simple brief which was to capture the key elements of our business; our people and our products. Snapping away around our production area he captured a number of excellent pictures including one that is now our brand.

The picture is of Kanda Nägelin who is one of our hardworking production staff. Claudio Scialdone who manages our manufacturing services, caught up with Kanda and found out a little more...

ww

w.tillotts.com T: +41 61 935 28 28

F: +41 61 935 28 29E: [email protected]

Tillotts Pharma AGTillotts ServicesHauptstrasse 274417 ZiefenSwitzerland

Tillotts Services will be represented at the following events during 2011. We would be delighted to meet with you.

Let’s Have Coffee...