www.tillotts.com

IN THIS ISSUE

APV Seminar with Plant tour in our facilities: Tillotts Services had the opportunity to participate with speakers on a seminar organized by APV Mainz. The highlight was the plant tour at the Tillotts Services facilities.

GMP Pilot Laboratory in Ziefen: Tillotts Services has decided to transform the former development laboratory into a GMP pilot laboratory in order to be able to offer scale up trials as well as manufacturing for clinical trials or small commercial volumes which are requested from time to time for contract manufacturing.

Interview: Salvatore Apostolo, Warehouse Manager.

APV Seminar with Plant Tour in our Ziefen FacilitiesIt was a pleasure to have the opportunity to participate with speakers in a seminar organized by APV Mainz, Germany on the topic “Hard capsules, including liquid and semi-solid filling”.

ww

w.tillotts.com

T: +41 61 935 28 28 F: +41 61 935 28 29 E: services@tillotts.com

For more information, please contact us at:

Tillotts Pharma AGTillotts Services, Hauptstrasse 274417 Ziefen, Switzerland

Follow us on LinkedIn:Please join our LinkedIn Group “Tillotts Services” on LinkedIn. We will inform you about several forthcoming events as well as the latest news within Tillotts Services.

See us on YouTube:If you are interested in the Liquid Fill Encapsulation Technology as well as in the manufacturing process of Tillotts Services you have now the opportunity to follow us on YouTube.

NEWSLETTER

In this edition Karin Strübin interviews Salvatore Apostolo, Warehouse Manager

INT

ER

VIE

W

Issue 12

Let’s Have Coffee..

Salvatore, please tell us a little about yourselfI was born in Liestal (CH) as an Italian citizen and my home town is called “Cassano allo Jonio”, a village in Calabria. When I was 15 years old I went back to Italy with my parents and lived there until I was 20, finishing normal school as well as a commercial school. In 1987 we came back to Switzerland where I took several language courses to improve my German.

Today, I live in Bubendorf, which is only approx. 3 km away from Ziefen. My wife and I have three children, two 18 year old girls (twins) and a 14 year old boy. My hobbies are soccer (unfortunately only as a spectator at the moment), listening to music, meeting with my friends and, of course, my family.What I miss extremely in Switzerland is the sea!

When did you join Tillotts?I’ve been working at Tillotts since May 2002 in the Logistics Department. When I joined Tillotts, I had the opportunity to complete a logistics apprenticeship and then went on to get a federal diploma as a Logistics Expert.

Please describe your role within Tillotts?At present I am Head of the Warehouse and I’m responsible for the logistics apprentice. In addition, I work as a part-time professional school teacher as well as expert for exams in the logistics area.

Of which project are you most proud?I am proud that I could complete an apprenticeship successfully as well as an advanced training as an adult and family man. Furthermore, I am proud that I could realise one of my dreams – working as a professional school teacher and also as an expert for exams. I like it a lot to work with adolescents and therefore, I am very happy to be responsible for the apprentice in the logistics area at Tillotts.

What will be your next major challenge at Tillotts?The organisation of a new and much bigger warehouse at Tillotts.

When will the sites in Ziefen and Rheinfelden be combined to have only one warehouse in the end?

What I always wanted to say...

07 - 09 October 2014 CPhI/ICSE Paris, France http://www.cphi.com/event-calendar

For more information please visit:

05 - 07 May 2015 Vitafoods Geneva, Switzerland http://www.vitafoods.eu.com

11 - 13 May 2015 BioTrinity London, UK http://www.biotrinity.com

For more information please visit:

For more information please visit:

Tillotts Services will be represented at the following events during 2014 & 2015. We would be delighted to meet with you.

The Seminar took place on June 24 and 25, 2014 in the Basel region. This 2-day interactive seminar was very successful, a highlight for the participants being the plant tour of the Tillotts Services facilities where we presented the different manufacturing systems we use for the encapsulation of liquids and semi-solids in hard capsules and their sealing.

We held presentations with the following titles:

• Hard capsules (supported by our collaboration partner Qualicaps S.A.).

• Capsule liquid filling and sealing technologies.

• Lipid-based formulations in hard capsules to improve bioavailability

Copyright © Tillotts Pharma AG 2014Colpermin is a registered trademark owned by Tillotts Pharma AG except in the UK and Ireland.

The rights to, including the rights to the trademark Asacol, are not owned by Tillotts Pharma AG in any of the following countries: Switzerland, USA, United Kingdom, Canada, Italy, Belgium, the Netherlands, and Luxembourg.

www.tillotts.com

Focus on TechnologyWithin this section we aim to profile a technology area related to our business.

GMP Pilot Laboratory in Ziefen is ready

In 2009 when no more space was available in the vicinity of the Ziefen site for the further growth of the company, the head office of Tillotts was moved from Ziefen to Rheinfelden into the B15 building there. The whole development group also moved from Ziefen to Rheinfelden as space was available in the new headquarters for laboratories for analytical development as well as for product development. In the development work Tillotts does, scale-up trials and manufacturing for clinical trials or small commercial volumes are requested from time to time and the same is offered by Tillotts Services in contract manufacturing.

In order to enable this manufacturing in-house, it was decided to start a project and transform the former development laboratory into a GMP pilot laboratory. The GMP pilot laboratory will serve Tillotts in the development of our own Asacol® and Colpermin® products as well as Tillotts Services for all kinds of contract manufacturing for third parties. The advantage of an own GMP pilot laboratory is, on the one hand, the reduction of external costs and, on the other hand and more importantly, the reduction of lead times. In all development work short lead times are of great importance. The reduction of development time in a project of weeks or months, will result in an earlier marketing of the product with the appropriate profit and the advantage against all the competitors.

After the decision of the board, to invest in a GMP pilot laboratory, the project was started. Project leader was our Head of Engineering, Thomas Kaiser and he ran the project in very close cooperation with Thomas Buser, our Advisor in Pharmaceutical Development. Both Thomas Kaiser and Thomas Buser have been with our company for more than 25 years and are very familiar with all the conditions at Tillotts. Running such a project with experienced internal resources is always very efficient, as all the staff know the actual situation exactly and they assume responsibility for a successful execution.

The project was divided into two parts:

a) Upgrading of the room to GMP conditions which meant upgrading the ventilation/climatisation system, installing an air lock for staff and material and adjusting the fittings in the room.

b) Evaluating, purchasing and installing the necessary equipment.

The whole project ran under our change control system which means all qualification and validation work was included in the project. The room conditions (temperature, humidity, pressure, particles, microbiological contamination) are monitored regularly. The cleaning of the room is regulated in an SOP and monitored by contact plates for microbiological contamination. In the GMP pilot laboratory we implemented the same conditions as we have in our GMP production rooms.

At present we have the following equipment ready to be used in our GMP pilot laboratory:

Pilot blister machine, EZ Blister T501-001-001 making it possible to use a variety of plastic blister foils and alu foil as cover.

a

b

Air lock for staff and material.

Beside the above mentioned machines we have all necessary devices for the preparation of mixtures, such as vessels, stirrers, homogenisers as well as a thermometer, balances, a weighing cabinet, a washing machine etc. in the GMP pilot laboratory.

Glatt Coater GMPC II Multi Lab with different sizes of coating drum for volumes between 2.5 and 12 liter. Aqueous as well as organic coating can be performed. The coating air is conditioned for the right temperature and humidity.

Capsule filling and banding machine ACG with a capacity of about 500 capsules per hour. All kinds of hard shell capsules (Gelatin and HPMC) can be filled with different kinds of filling mixtures from low viscosity oils to pasty mixtures or hot melt formulations.

In 1986, when the Tillotts factory in Ziefen was built, it was planned to have two laboratories in addition to the production and all necessary offices, namely a quality control laboratory and a development laboratory on site. During several years all development work for our products and for our projects was done in this development laboratory. With the growth of the company, the staff in the development team also increased and there came the time when we rented additional space for our development in facilities situated nearby.

Tablet/capsule counting device, SwiftCount for the filling of e.g. duma bottles.

Microscope for the visual check of particles in a formulation.

Copyright © Tillotts Pharma AG 2014Colpermin is a registered trademark owned by Tillotts Pharma AG except in the UK and Ireland.

The rights to, including the rights to the trademark Asacol, are not owned by Tillotts Pharma AG in any of the following countries: Switzerland, USA, United Kingdom, Canada, Italy, Belgium, the Netherlands, and Luxembourg.

www.tillotts.com

Focus on TechnologyWithin this section we aim to profile a technology area related to our business.

GMP Pilot Laboratory in Ziefen is ready

In 2009 when no more space was available in the vicinity of the Ziefen site for the further growth of the company, the head office of Tillotts was moved from Ziefen to Rheinfelden into the B15 building there. The whole development group also moved from Ziefen to Rheinfelden as space was available in the new headquarters for laboratories for analytical development as well as for product development. In the development work Tillotts does, scale-up trials and manufacturing for clinical trials or small commercial volumes are requested from time to time and the same is offered by Tillotts Services in contract manufacturing.

In order to enable this manufacturing in-house, it was decided to start a project and transform the former development laboratory into a GMP pilot laboratory. The GMP pilot laboratory will serve Tillotts in the development of our own Asacol® and Colpermin® products as well as Tillotts Services for all kinds of contract manufacturing for third parties. The advantage of an own GMP pilot laboratory is, on the one hand, the reduction of external costs and, on the other hand and more importantly, the reduction of lead times. In all development work short lead times are of great importance. The reduction of development time in a project of weeks or months, will result in an earlier marketing of the product with the appropriate profit and the advantage against all the competitors.

After the decision of the board, to invest in a GMP pilot laboratory, the project was started. Project leader was our Head of Engineering, Thomas Kaiser and he ran the project in very close cooperation with Thomas Buser, our Advisor in Pharmaceutical Development. Both Thomas Kaiser and Thomas Buser have been with our company for more than 25 years and are very familiar with all the conditions at Tillotts. Running such a project with experienced internal resources is always very efficient, as all the staff know the actual situation exactly and they assume responsibility for a successful execution.

The project was divided into two parts:

a) Upgrading of the room to GMP conditions which meant upgrading the ventilation/climatisation system, installing an air lock for staff and material and adjusting the fittings in the room.

b) Evaluating, purchasing and installing the necessary equipment.

The whole project ran under our change control system which means all qualification and validation work was included in the project. The room conditions (temperature, humidity, pressure, particles, microbiological contamination) are monitored regularly. The cleaning of the room is regulated in an SOP and monitored by contact plates for microbiological contamination. In the GMP pilot laboratory we implemented the same conditions as we have in our GMP production rooms.

At present we have the following equipment ready to be used in our GMP pilot laboratory:

Pilot blister machine, EZ Blister T501-001-001 making it possible to use a variety of plastic blister foils and alu foil as cover.

a

b

Air lock for staff and material.

Beside the above mentioned machines we have all necessary devices for the preparation of mixtures, such as vessels, stirrers, homogenisers as well as a thermometer, balances, a weighing cabinet, a washing machine etc. in the GMP pilot laboratory.

Glatt Coater GMPC II Multi Lab with different sizes of coating drum for volumes between 2.5 and 12 liter. Aqueous as well as organic coating can be performed. The coating air is conditioned for the right temperature and humidity.

Capsule filling and banding machine ACG with a capacity of about 500 capsules per hour. All kinds of hard shell capsules (Gelatin and HPMC) can be filled with different kinds of filling mixtures from low viscosity oils to pasty mixtures or hot melt formulations.

In 1986, when the Tillotts factory in Ziefen was built, it was planned to have two laboratories in addition to the production and all necessary offices, namely a quality control laboratory and a development laboratory on site. During several years all development work for our products and for our projects was done in this development laboratory. With the growth of the company, the staff in the development team also increased and there came the time when we rented additional space for our development in facilities situated nearby.

Tablet/capsule counting device, SwiftCount for the filling of e.g. duma bottles.

Microscope for the visual check of particles in a formulation.

www.tillotts.com

IN THIS ISSUE

APV Seminar with Plant tour in our facilities: Tillotts Services had the opportunity to participate with speakers on a seminar organized by APV Mainz. The highlight was the plant tour at the Tillotts Services facilities.

GMP Pilot Laboratory in Ziefen: Tillotts Services has decided to transform the former development laboratory into a GMP pilot laboratory in order to be able to offer scale up trials as well as manufacturing for clinical trials or small commercial volumes which are requested from time to time for contract manufacturing.

Interview: Salvatore Apostolo, Warehouse Manager.

APV Seminar with Plant Tour in our Ziefen FacilitiesIt was a pleasure to have the opportunity to participate with speakers in a seminar organized by APV Mainz, Germany on the topic “Hard capsules, including liquid and semi-solid filling”.

ww

w.tillotts.com

T: +41 61 935 28 28 F: +41 61 935 28 29 E: services@tillotts.com

For more information, please contact us at:

Tillotts Pharma AGTillotts Services, Hauptstrasse 274417 Ziefen, Switzerland

Follow us on LinkedIn:Please join our LinkedIn Group “Tillotts Services” on LinkedIn. We will inform you about several forthcoming events as well as the latest news within Tillotts Services.

See us on YouTube:If you are interested in the Liquid Fill Encapsulation Technology as well as in the manufacturing process of Tillotts Services you have now the opportunity to follow us on YouTube.

NEWSLETTER

In this edition Karin Strübin interviews Salvatore Apostolo, Warehouse Manager

INT

ER

VIE

W

Issue 12

Let’s Have Coffee..

Salvatore, please tell us a little about yourselfI was born in Liestal (CH) as an Italian citizen and my home town is called “Cassano allo Jonio”, a village in Calabria. When I was 15 years old I went back to Italy with my parents and lived there until I was 20, finishing normal school as well as a commercial school. In 1987 we came back to Switzerland where I took several language courses to improve my German.

Today, I live in Bubendorf, which is only approx. 3 km away from Ziefen. My wife and I have three children, two 18 year old girls (twins) and a 14 year old boy. My hobbies are soccer (unfortunately only as a spectator at the moment), listening to music, meeting with my friends and, of course, my family.What I miss extremely in Switzerland is the sea!

When did you join Tillotts?I’ve been working at Tillotts since May 2002 in the Logistics Department. When I joined Tillotts, I had the opportunity to complete a logistics apprenticeship and then went on to get a federal diploma as a Logistics Expert.

Please describe your role within Tillotts?At present I am Head of the Warehouse and I’m responsible for the logistics apprentice. In addition, I work as a part-time professional school teacher as well as expert for exams in the logistics area.

Of which project are you most proud?I am proud that I could complete an apprenticeship successfully as well as an advanced training as an adult and family man. Furthermore, I am proud that I could realise one of my dreams – working as a professional school teacher and also as an expert for exams. I like it a lot to work with adolescents and therefore, I am very happy to be responsible for the apprentice in the logistics area at Tillotts.

What will be your next major challenge at Tillotts?The organisation of a new and much bigger warehouse at Tillotts.

When will the sites in Ziefen and Rheinfelden be combined to have only one warehouse in the end?

What I always wanted to say...

07 - 09 October 2014 CPhI/ICSE Paris, France http://www.cphi.com/event-calendar

For more information please visit:

05 - 07 May 2015 Vitafoods Geneva, Switzerland http://www.vitafoods.eu.com

11 - 13 May 2015 BioTrinity London, UK http://www.biotrinity.com

For more information please visit:

For more information please visit:

Tillotts Services will be represented at the following events during 2014 & 2015. We would be delighted to meet with you.

The Seminar took place on June 24 and 25, 2014 in the Basel region. This 2-day interactive seminar was very successful, a highlight for the participants being the plant tour of the Tillotts Services facilities where we presented the different manufacturing systems we use for the encapsulation of liquids and semi-solids in hard capsules and their sealing.

We held presentations with the following titles:

• Hard capsules (supported by our collaboration partner Qualicaps S.A.).

• Capsule liquid filling and sealing technologies.

• Lipid-based formulations in hard capsules to improve bioavailability