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Tillotts Services Newsletter Issue 5
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24 - 26 April 2012
BioTrinityNewbury, UK
For more information please visit: http://www.biotrinity.com
22 – 23 May 2012
ICSEPhiladelphia, USA
For more information please visit:http://www.icsexpo.com/usa
23 – 24 May 2012
Outsourcing Pharmaceutical Manufacturing and AnalyticsHamburg, Germany
For more information please visit:http://www.informaglobalevents.com/event/outsourcingpharma
14 June 2012
Biotech Outsourcing Strategies cmcCopenhagen, Denmark
For more information please visit:http://www.bio2bevents.com
www.tillotts.com
In this issue we provide an overview of our Project Management System which is integrated into our new Project Portfolio System. Within our “Focus on Technology” section we profile our experience with Differential Scanning Calorimetry. Finally we provide an update on forthcoming events and our staff interview.
Within Tillotts Services we manage a range of development, commercial and life-cycle management projects, hence it is important for us to predict and manage workflows and remove potential resource constraints. The Project Management System (PMS) is an important management tool within our business and has been established through the careful consideration of how individual projects are supervised, planned and controlled. At the outset, careful consideration is given to clearly defining the project goal(s), key milestones, budget, project organisation structure and is supported by a thorough risk assessment. Project schedules are generated using MS-Project in which specific milestones are defined by our customer and supported by regular internal and external project review meetings that maximises the chances of a positive project outcome and on-time delivery to our customer.
Project Organisation is also an essential element where clearly defined responsibilities within the project team are established. An additional consideration is the manner and frequency in how we communicate within the project organisation, we use a combination of face-to-face meetings and applicable IT tools. Therefore a defined project organisation is mandatory and issued for each individual project within our business. Projects are managed by one of our experienced colleagues from the Tillotts Services Team. In Figure 1 an example of a typical Project Organisation is shown.
In addition to the PMS, a Project Portfolio System (PPS) has also been implemented to handle, evaluate and coordinate our projects. This approach allows good coordination with our customers project teams at both the scientific and operational levels.
Issue 5
NEWSLETTER
Acknowledgements: Design by David Anthony, AK Design (Scotland) Ltd.
For more information, please contact us at:
Q: So Simon please tell us a little about yourself?
A: I live in Bubendorf (next village to Ziefen). I have two children, a 17 year old son and a 19 year old daughter. In my free time I spend a lot of time on my motorbike, play football, go in-line skating and travel.
Q: When did you join Tillotts?
A: I joined in April 2000.
Q: What is your function at Tillotts?
A: I am head of production and packaging and manage all internal production and packaging orders in our facility in Ziefen and I am responsible for 20 employees.
Q: What was the biggest challenge for you at Tillotts?
A: Every day is a new challenge and this makes my work in Ziefen very attractive. To support the staff in uncertain situations, to motivate them, build up and maintain a well harmonised team. Being there for each other and we can give our best. Every person should be motivated at work.
Q: Of which projects are you most proud?
A: The expansion of our packaging capabilities was a challenge as was the training of new staff to manage new products.
Q: What will be your next big challenge at Tillotts?
A: The installation and establishment of our new Enema Line and Coating equipment will be my next big challenge. Therefore it is important to train the staff to operate the new equipment.
I have been with Tillotts now for 12 years and have always received a lot of support as well as using my experience to support other departments. In my opinion that is not a matter of course and so I am proud to be a member of the Tillotts team.
In this edition Claudio Scialdone interviews Simon Kiener, Head of Production and Packaging within Tillotts Services.
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 the next quarter.We would be delighted to meet with you.
Let’s Have Coffee..
Tillotts Services will be located at Exhibition Stand 33. Please come and visit us.
Project Management System within Tillotts Services
Project Giver / Customer
Project Manager
Administration
Sub-Project Manager(Sub-Project A)
Sub-Project Manager(Sub-Project B)
Sub-Project Manager(Sub-Project C)
InternalStakeholders
Management Finance
QALogistics
QC
ExternalStakeholders
CustomersSuppliers
GMP /Authorities Regulatory
Others
Figure 1 Typical Project Organisation
Case Studies:Do you already know our case studies? 1. Colpermin® 2. Optimisation of a Phase II Formulation 3. NCE bioavailability enhancement using a SMEDDS formulation.Available on our website!
Fusion
Purity
Polymorphism
Crystallinity
Water/Hydrates
Drug/Excipientinteraction
Heat capacitymeasurement
Degradation/Decomposition
Glasstransition
Copyright © Tillotts Pharma AG 2012 www.tillotts.com
Focus on TechnologyWithin this section we aim to profile a technology area related to our business.
Differential Scanning Calorimetry (DSC) is an important tool used in early pharmaceutical development and conforms to the Quality by Design (QbD) principle (ICHQ8). Key advantages of this technique are the; (i) expedient physicochemical characterisation, (ii) rapid screening of API’s or excipients and (iii) use of very small sample(s).
Application: DSC is a thermal analytical technique that provides valuable data in relation to the physical and enthalpic (energetic) properties of a substance. Enthalpic transitions may be; (i) endothermic e.g. fusion, vaporisation, desolvation, or (ii) exothermic e.g. crystallisation, condensation, solidification, solvation or others such as glass transition.
Important applications of DSC are shown in Figure 2. The most commonly used applications by Tillotts Services are those related to lipid-based formulations such as the characterisation of thermo-softening excipients to control crystallisation on cooling as well as their stability on heating over time at different temperatures. This is useful in the early investigation of changes that could occur during filling of the lipid-based formulation into hard gelatine capsules, especially those at high temperatures (up to 75° C for liquid-fill encapsulation). Moreover, most lipid-based formulations exhibit changes in crystal structure (polymorphism) on cooling or aging, thus DSC is a very powerful analytical tool in identifying this behaviour. Another important application is the determination of drug-excipient interaction during pre-formulation studies.
Principle: The DSC measures the energy difference of two linearly heated pans (sample and reference) as a function of temperature (Figure 3). The instrument can be used to control the heating or cooling of the samples. Improved sensitivity can be achieved through increasing the scanning rate, while reducing the rate improves the resolution. Other advanced modes include modulated DSC (MDSC) and dynamic DSC (DDSC). MDSC with a sinusoidal ramp can be applied to avoid hiding of peaks that suggest other transitions if the conventional DSC technique is applied.
This technique is very useful for detecting the recrystallisation of different components of a lipid excipient such as Gelucire. Due to its high resolution, the identification of differentiating overlapping transitions as well as distinguishing between reversible and irreversible transitions is possible. Another useful technique is dynamic DSC (DDSC) which involves repeated scans in either “Heat-Cool” or “Iso-Scan” scan modes. The Heat-Cool repeated scan is applied to extract an obscured glass transition especially on storage. The Iso-Scan is composed of multiple temperature program steps i.e. the heating rate program is combined with iso-thermal holds.
Samples: are analysed in small metal pans, Figure 4, with optimal conductivity e.g. aluminum, platinum, stainless steel, silver, gold. Pans may be open, pin-hole, covered or sealed. Sample sizes of 3–7 mg are common for pharmaceutical materials.
Figure 3 DSC two ovens with covers, one for the sample (left) and one for the reference (right)
Figure 4 Aluminium Pans sealed and with hole for sample analysis
Figure 1PerkinElmer Differential Scanning Calorimeter (DSC 8000)
Figure 2 Pharmaceutical applications of DSC
20
Figure 5 DSC Thermogram for a lipid material showing some characteristic thermodynamic parameters
Figure 5 shows the DSC thermogram for a lipid material that is subjected to heating (red) and cooling (green) cycles.
The material is melted at 37.7° C and solidified at 17.59° C; a shift in these values with storage would indicate a polymorphic change.
00 5 10 15 20 25 30
Temperature (° C)
End = 15.20° C
Hea
t Fl
ow E
ndo
Up
(mW
)
35 40 45 50 55 60
2
4
6
8
10
12
14
16
18
Onset = 19.38° CEnd = 38.89° C
Onset = 34.56° C
Peak = 37.73° CPeak Height = 3.5558mW
Peak = 17.59° CPeak Height = -2.9906mW
Area = 337.463 mJDelta H = 64.8967 J/g
Area = -141.138 mJDelta H = -27.1420 J/g
Differential Scanning Calorimetry
Fusion
Purity
Polymorphism
Crystallinity
Water/Hydrates
Drug/Excipientinteraction
Heat capacitymeasurement
Degradation/Decomposition
Glasstransition
Copyright © Tillotts Pharma AG 2012 www.tillotts.com
Focus on TechnologyWithin this section we aim to profile a technology area related to our business.
Differential Scanning Calorimetry (DSC) is an important tool used in early pharmaceutical development and conforms to the Quality by Design (QbD) principle (ICHQ8). Key advantages of this technique are the; (i) expedient physicochemical characterisation, (ii) rapid screening of API’s or excipients and (iii) use of very small sample(s).
Application: DSC is a thermal analytical technique that provides valuable data in relation to the physical and enthalpic (energetic) properties of a substance. Enthalpic transitions may be; (i) endothermic e.g. fusion, vaporisation, desolvation, or (ii) exothermic e.g. crystallisation, condensation, solidification, solvation or others such as glass transition.
Important applications of DSC are shown in Figure 2. The most commonly used applications by Tillotts Services are those related to lipid-based formulations such as the characterisation of thermo-softening excipients to control crystallisation on cooling as well as their stability on heating over time at different temperatures. This is useful in the early investigation of changes that could occur during filling of the lipid-based formulation into hard gelatine capsules, especially those at high temperatures (up to 75° C for liquid-fill encapsulation). Moreover, most lipid-based formulations exhibit changes in crystal structure (polymorphism) on cooling or aging, thus DSC is a very powerful analytical tool in identifying this behaviour. Another important application is the determination of drug-excipient interaction during pre-formulation studies.
Principle: The DSC measures the energy difference of two linearly heated pans (sample and reference) as a function of temperature (Figure 3). The instrument can be used to control the heating or cooling of the samples. Improved sensitivity can be achieved through increasing the scanning rate, while reducing the rate improves the resolution. Other advanced modes include modulated DSC (MDSC) and dynamic DSC (DDSC). MDSC with a sinusoidal ramp can be applied to avoid hiding of peaks that suggest other transitions if the conventional DSC technique is applied.
This technique is very useful for detecting the recrystallisation of different components of a lipid excipient such as Gelucire. Due to its high resolution, the identification of differentiating overlapping transitions as well as distinguishing between reversible and irreversible transitions is possible. Another useful technique is dynamic DSC (DDSC) which involves repeated scans in either “Heat-Cool” or “Iso-Scan” scan modes. The Heat-Cool repeated scan is applied to extract an obscured glass transition especially on storage. The Iso-Scan is composed of multiple temperature program steps i.e. the heating rate program is combined with iso-thermal holds.
Samples: are analysed in small metal pans, Figure 4, with optimal conductivity e.g. aluminum, platinum, stainless steel, silver, gold. Pans may be open, pin-hole, covered or sealed. Sample sizes of 3–7 mg are common for pharmaceutical materials.
Figure 3 DSC two ovens with covers, one for the sample (left) and one for the reference (right)
Figure 4 Aluminium Pans sealed and with hole for sample analysis
Figure 1PerkinElmer Differential Scanning Calorimeter (DSC 8000)
Figure 2 Pharmaceutical applications of DSC
20
Figure 5 DSC Thermogram for a lipid material showing some characteristic thermodynamic parameters
Figure 5 shows the DSC thermogram for a lipid material that is subjected to heating (red) and cooling (green) cycles.
The material is melted at 37.7° C and solidified at 17.59° C; a shift in these values with storage would indicate a polymorphic change.
00 5 10 15 20 25 30
Temperature (° C)
End = 15.20° C
Hea
t Fl
ow E
ndo
Up
(mW
)
35 40 45 50 55 60
2
4
6
8
10
12
14
16
18
Onset = 19.38° CEnd = 38.89° C
Onset = 34.56° C
Peak = 37.73° CPeak Height = 3.5558mW
Peak = 17.59° CPeak Height = -2.9906mW
Area = 337.463 mJDelta H = 64.8967 J/g
Area = -141.138 mJDelta H = -27.1420 J/g
Differential Scanning Calorimetry
24 - 26 April 2012
BioTrinityNewbury, UK
For more information please visit: http://www.biotrinity.com
22 – 23 May 2012
ICSEPhiladelphia, USA
For more information please visit:http://www.icsexpo.com/usa
23 – 24 May 2012
Outsourcing Pharmaceutical Manufacturing and AnalyticsHamburg, Germany
For more information please visit:http://www.informaglobalevents.com/event/outsourcingpharma
14 June 2012
Biotech Outsourcing Strategies cmcCopenhagen, Denmark
For more information please visit:http://www.bio2bevents.com
www.tillotts.com
In this issue we provide an overview of our Project Management System which is integrated into our new Project Portfolio System. Within our “Focus on Technology” section we profile our experience with Differential Scanning Calorimetry. Finally we provide an update on forthcoming events and our staff interview.
Within Tillotts Services we manage a range of development, commercial and life-cycle management projects, hence it is important for us to predict and manage workflows and remove potential resource constraints. The Project Management System (PMS) is an important management tool within our business and has been established through the careful consideration of how individual projects are supervised, planned and controlled. At the outset, careful consideration is given to clearly defining the project goal(s), key milestones, budget, project organisation structure and is supported by a thorough risk assessment. Project schedules are generated using MS-Project in which specific milestones are defined by our customer and supported by regular internal and external project review meetings that maximises the chances of a positive project outcome and on-time delivery to our customer.
Project Organisation is also an essential element where clearly defined responsibilities within the project team are established. An additional consideration is the manner and frequency in how we communicate within the project organisation, we use a combination of face-to-face meetings and applicable IT tools. Therefore a defined project organisation is mandatory and issued for each individual project within our business. Projects are managed by one of our experienced colleagues from the Tillotts Services Team. In Figure 1 an example of a typical Project Organisation is shown.
In addition to the PMS, a Project Portfolio System (PPS) has also been implemented to handle, evaluate and coordinate our projects. This approach allows good coordination with our customers project teams at both the scientific and operational levels.
Issue 5
NEWSLETTER
Acknowledgements: Design by David Anthony, AK Design (Scotland) Ltd.
For more information, please contact us at:
Q: So Simon please tell us a little about yourself?
A: I live in Bubendorf (next village to Ziefen). I have two children, a 17 year old son and a 19 year old daughter. In my free time I spend a lot of time on my motorbike, play football, go in-line skating and travel.
Q: When did you join Tillotts?
A: I joined in April 2000.
Q: What is your function at Tillotts?
A: I am head of production and packaging and manage all internal production and packaging orders in our facility in Ziefen and I am responsible for 20 employees.
Q: What was the biggest challenge for you at Tillotts?
A: Every day is a new challenge and this makes my work in Ziefen very attractive. To support the staff in uncertain situations, to motivate them, build up and maintain a well harmonised team. Being there for each other and we can give our best. Every person should be motivated at work.
Q: Of which projects are you most proud?
A: The expansion of our packaging capabilities was a challenge as was the training of new staff to manage new products.
Q: What will be your next big challenge at Tillotts?
A: The installation and establishment of our new Enema Line and Coating equipment will be my next big challenge. Therefore it is important to train the staff to operate the new equipment.
I have been with Tillotts now for 12 years and have always received a lot of support as well as using my experience to support other departments. In my opinion that is not a matter of course and so I am proud to be a member of the Tillotts team.
In this edition Claudio Scialdone interviews Simon Kiener, Head of Production and Packaging within Tillotts Services.
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 the next quarter.We would be delighted to meet with you.
Let’s Have Coffee..
Tillotts Services will be located at Exhibition Stand 33. Please come and visit us.
Project Management System within Tillotts Services
Project Giver / Customer
Project Manager
Administration
Sub-Project Manager(Sub-Project A)
Sub-Project Manager(Sub-Project B)
Sub-Project Manager(Sub-Project C)
InternalStakeholders
Management Finance
QALogistics
QC
ExternalStakeholders
CustomersSuppliers
GMP /Authorities Regulatory
Others
Figure 1 Typical Project Organisation
Case Studies:Do you already know our case studies? 1. Colpermin® 2. Optimisation of a Phase II Formulation 3. NCE bioavailability enhancement using a SMEDDS formulation.Available on our website!
