Newsletter 6
4
www.tillotts.com We are delighted to present you with our third quarterly 2012 newsletter which we hope you enjoy. Within our technology section we profile our TOC Analyser which is a key piece of kit within our QC department. We also report on our recent presentation at the Biotech Outsourcing Strategies meeting in Copenhagen. Finally we provide details of our forthcoming conference and exhibition attendance along with our staff interview. This month we were invited to present a paper at the “Biotech Outsourcing Strategies” CMC conference in Copenhagen entitled, “Lipid Self-Dispersing Formulations to Improve Biopharmaceutical Properties of Weak Soluble Compounds”. This is becoming an increasingly important area as evidenced by a continued increase in poorly water soluble compounds coming through early development. With respect to our own technology focus within liquid- fill encapsulation using two-piece, hard-shell capsules, the development of lipid-based oral drug delivery formulations is primarily driven by the desire to increase and/or make reproducible the oral bioavailability of poorly aqueous soluble molecules. These typically exhibit erratic and variable pharmacokinetic profiles after the oral administration of conventional solid forms. Lipid- based formulations range from simple oily solutions to complex mixtures of oils, surfactants, co-surfactants and co-solvents, classified as lipid self-emulsifying (SEDDS) or micro-emulsifying drug delivery systems (SMEDDS). Due to their ability to maintain the active molecule dissolved and/or to prevent precipitation in vivo, self- dispersing lipid formulations are of high pharmaceutical interest for improving biopharmaceutical properties of active molecules. Our presentation gave an overview of the development methodology of lipid self-dispersing formulations for hard shell capsules, covering important bio-relevant in vitro tests for assessing the formulation performance. Within Tillotts Services, we have the state of the art instruments and equipment available from early development up to large scale industrial manufacturing, as such we can offer a “one-stop-shop” approach from early pre-clinical development through to commercial manufacture and supply. Summary of Benefits for a Lipid-based approach: Lipid Self Emulsifying Formulations represent a powerful approach to increase solubility and oral bioavailability of poorly soluble drugs SMEDDS should be tailor-made developed for the corresponding active compound (not “as general model-formulation or formulation kit”) For BCS class II compounds, an early investigation of the lipid formulation approach is advisable for the satisfactory drug product development In vitro bio-relevant tests should be considered in pharmaceutical development and as basis for in vitro – in vivo predictions (i.e. dispersion in simulated gastrointestinal fluids and lipolysis test) For a copy of our presentation please contact Miriam Adler, Marketing Assistant Tel. +41 61 935 2804 If you want further details of how we can help, please contact Claudio Scialdone, Senior Manager Contract Services & Business Development Tel. +41 61 935 2840 Issue 6 NEWSLETTER Biotech Outsourcing Strategies cmc - Copenhagen
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Tillotts Services Newsletter Issue 6
Transcript of Newsletter 6
25 September 2012
Biotech Outsourcing Strategies 2012London, UKPlease come and visit us on stand 25 For more information please visit: http://www.bio2bevents.com
9 – 11 October 2012 CPhI Madrid, SpainPlease come and visit us on stand 10A93 For more information please visit:http://www.cphi.com
14 - 18 October 2012
aapsChicago, USAFor more information please visit:http://www.aaps.org/annualmeeting/
www.tillotts.com
We are delighted to present you with our third quarterly 2012 newsletter which we hope you enjoy. Within our technology section we profile our TOC Analyser which is a key piece of kit within our QC department. We also report on our recent presentation at the Biotech Outsourcing Strategies meeting in Copenhagen. Finally we provide details of our forthcoming conference and exhibition attendance along with our staff interview.
This month we were invited to present a paper at the “Biotech Outsourcing Strategies” CMC conference in Copenhagen entitled, “Lipid Self-Dispersing Formulations to Improve Biopharmaceutical Properties of Weak Soluble Compounds”. This is becoming an increasingly important area as evidenced by a continued increase in poorly water soluble compounds coming through early development.
With respect to our own technology focus within liquid-fill encapsulation using two-piece, hard-shell capsules, the development of lipid-based oral drug delivery formulations is primarily driven by the desire to increase and/or make reproducible the oral bioavailability of poorly aqueous soluble molecules. These typically exhibit erratic and variable pharmacokinetic profiles after the oral administration of conventional solid forms. Lipid-based formulations range from simple oily solutions to complex mixtures of oils, surfactants, co-surfactants and co-solvents, classified as lipid self-emulsifying (SEDDS) or micro-emulsifying drug delivery systems (SMEDDS). Due to their ability to maintain the active molecule dissolved and/or to prevent precipitation in vivo, self-dispersing lipid formulations are of high pharmaceutical interest for improving biopharmaceutical properties of active molecules. Our presentation gave an overview of the development methodology of lipid self-dispersing formulations for hard shell capsules, covering important bio-relevant in vitro tests for assessing the formulation performance.
Within Tillotts Services, we have the state of the art instruments and equipment available from early development up to large scale industrial manufacturing, as such we can offer a “one-stop-shop” approach from early pre-clinical development through to commercial manufacture and supply.
Summary of Benefits for a Lipid-based approach:
Lipid Self Emulsifying Formulations represent a powerful approach to increase solubility and oral bioavailability of poorly soluble drugs
SMEDDS should be tailor-made developed for the corresponding active compound (not “as general model-formulation or formulation kit”)
For BCS class II compounds, an early investigation of the lipid formulation approach is advisable for the satisfactory drug product development
In vitro bio-relevant tests should be considered in pharmaceutical development and as basis for in vitro – in vivo predictions (i.e. dispersion in simulated gastrointestinal fluids and lipolysis test)
For a copy of our presentation please contact Miriam Adler, Marketing Assistant Tel. +41 61 935 2804
If you want further details of how we can help, please contact Claudio Scialdone, Senior Manager Contract Services & Business DevelopmentTel. +41 61 935 2840
Issue 6
NEWSLETTER
Acknowledgements: Design by David Anthony, AK Design (Scotland) Ltd.
For more information, please contact us at:
Q: So Sarah please tell us a little about yourself?
A: I was born in Germany where I completed an apprenticeship as a “Chemical Technician Assistant”. During the last 6 years I have lived in Switzerland. Initially I worked as a Lab-Technician at MDS Pharma Services in Zurich. After that I moved to Basel, and worked for a range of life science companies so I have been lucky to develop a range of experience which I can now apply at Tillotts Services.
My hobbies are mountain biking, dancing (Standard/Latin and Lindy Hop) and spending time with my boyfriend.
Q: When did you join Tillotts?
A: I joined Tillotts as a Lab-Technician in the Quality Control in September 2010.
Q: What is your role within Tillotts?
A: Within my current role I analyse and evaluate the samples from our production department and report back the results. I also manage the ordering of chemicals for the Lab, and write the Analytical Report. However my role is about to change.
Q: What was the biggest challenge for you at Tillotts?
A: I have enjoyed the challenge of managing a diverse and complex workload that now includes a secondment to Quality Assurance.
Q: What will be your next big challenge at Tillotts?
A: My next bigger challenge will be my move from Quality Control to Quality Assurance. In the future I will undertake the approval of all GMP-Documents at our Ziefen facility such as SOPs/working instructions or deviation reports. The biggest challenge for me will be to learn more about our GMP-System. For the future it means that I still work with the Quality Control but also with all other departments in Ziefen.
Q: Of which project are you most proud?
A: I’m proud of the new ordering system for our laboratory chemicals which facilitates good stock control and on-time delivery from our suppliers.
In this edition Miriam Adler interviews Sarah Lutz, Lab Technician 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 2012. We would be delighted to meet with you.
Let’s Have Coffee..
Biotech Outsourcing Strategies cmc - Copenhagen
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.
Copyright © Tillotts Pharma AG 2012 www.tillotts.com
Focus on TechnologyWithin this section we aim to profile a technology area related to our business.
In July 2011 a new TOC Analyser was installed and qualified in Quality Control. This equipment is used for measuring the Total Organic Carbon (TOC) content in liquid, solid or gaseous samples. It can be used in many applications for example cleaning validations, to verify the effectiveness of cleaning procedures and analysing the purity of different water qualities e.g. waste water, drinking water and water for pharmaceutical use. The TOC content is a very important sum parameter and implemented in many monographs in all pharmacopoeias. The TOC analysis is an unspecific method determining all organic components that can be oxidised to carbon dioxide (CO2) which is determined quantitatively and very precisely by UV absorption. The advantage is that all components are measured in one run and that even unknown compounds like impurities are captured. In contrast other methods like chromatography (HPLC) or spectroscopy (UV, IR) detect and quantify a specific component only like the active substance (e.g. mebeverine hydrochloride) or a cleaning agent.
There are two different kinds of preparation methods: the wet chemical oxidation and the combustion catalytic oxidation method. The commercially available TOC Analysers all have very wide measuring ranges over several decades of e.g 4 μg/L up to 30’000 mg/L for the actual type TOC-L CPH of Shimadzu. This is facilitated by diluting the sample solution. The calibration of the analytical method is done by means of a standard solution with a certified content of organic carbon of 1000 mg/L. Of course, an SST (system suitability test) is performed with two independent references (benzoquinone, saccharose) to show the proper function of the whole system.
Conclusion:
The new TOC-L CPH Analyser of Shimadzu was installed and qualified without problems. It was used since then in cleaning validations (showing in 3 runs the validity of the general cleaning procedure) and in the verification of a single cleaning procedure e.g. after the custom manufacturing of capsules for a clinical trial where only one batch of placebo and verum were produced. Here the result of the cleaning is available on the next day and enables a quick decision whether a second cleaning is necessary or not and therefore avoiding long times of cessation in production.
It is a very useful piece of equipment that is also quite robust; after some initial trials we are now familiar with its routine use. It has a wide measuring range and the analysis can be performed very quickly with high precision. The handling of the TOC system (equipment and software) is easy, so an effective and efficient working is possible. Last but not least we chose Shimadzu because of having a partner with great experience and reliable service not only in TOC analysis but other analytical techniques (IR, UV) that gives support in technical aspects, methods and qualification. We have a service contract in place like for other analytical equipment.
Summary description of the TOC Analyser in QC
Model: Shimadzu TOC-L CPH (see figure 1)
Type: combustion type analyser
Software: compliant to 21 CFR Part 11 (FDA)
Use of normal or sensitive catalyst, analysing down to a limit of detection in ppm to ppb range*
Autosampler ASI-L for effective and efficient working
Automatic sample acidification/sparging
Automatic dilution function (if the TOC content is too high for direct measuring)
*ppm = parts per million (10-6), ppb = parts per billion (10-9)
Figure 1Actual TOC Analyser (right) with Autosampler (left)
Figure 2TOC Analyser with SSM-5000A (solid sampler module)
Figure 3Sampler for simultaneous analysis of TOC and Nitrogen
Figure 4Shimadzu TOC-V system (wet chemical oxidation)
TOC Analyser in Quality Control
There are other variable accessories and kits for each type of application e.g. solid sampler module SSM-5000A (see figure 2), simultaneous analysis of TOC and Nitrogen (see figure 3), wet chemical oxidation (see figure 4).
Tillotts Services will be located at Exhibition Stand 25. Please come and visit us.
Copyright © Tillotts Pharma AG 2012 www.tillotts.com
Focus on TechnologyWithin this section we aim to profile a technology area related to our business.
In July 2011 a new TOC Analyser was installed and qualified in Quality Control. This equipment is used for measuring the Total Organic Carbon (TOC) content in liquid, solid or gaseous samples. It can be used in many applications for example cleaning validations, to verify the effectiveness of cleaning procedures and analysing the purity of different water qualities e.g. waste water, drinking water and water for pharmaceutical use. The TOC content is a very important sum parameter and implemented in many monographs in all pharmacopoeias. The TOC analysis is an unspecific method determining all organic components that can be oxidised to carbon dioxide (CO2) which is determined quantitatively and very precisely by UV absorption. The advantage is that all components are measured in one run and that even unknown compounds like impurities are captured. In contrast other methods like chromatography (HPLC) or spectroscopy (UV, IR) detect and quantify a specific component only like the active substance (e.g. mebeverine hydrochloride) or a cleaning agent.
There are two different kinds of preparation methods: the wet chemical oxidation and the combustion catalytic oxidation method. The commercially available TOC Analysers all have very wide measuring ranges over several decades of e.g 4 μg/L up to 30’000 mg/L for the actual type TOC-L CPH of Shimadzu. This is facilitated by diluting the sample solution. The calibration of the analytical method is done by means of a standard solution with a certified content of organic carbon of 1000 mg/L. Of course, an SST (system suitability test) is performed with two independent references (benzoquinone, saccharose) to show the proper function of the whole system.
Conclusion:
The new TOC-L CPH Analyser of Shimadzu was installed and qualified without problems. It was used since then in cleaning validations (showing in 3 runs the validity of the general cleaning procedure) and in the verification of a single cleaning procedure e.g. after the custom manufacturing of capsules for a clinical trial where only one batch of placebo and verum were produced. Here the result of the cleaning is available on the next day and enables a quick decision whether a second cleaning is necessary or not and therefore avoiding long times of cessation in production.
It is a very useful piece of equipment that is also quite robust; after some initial trials we are now familiar with its routine use. It has a wide measuring range and the analysis can be performed very quickly with high precision. The handling of the TOC system (equipment and software) is easy, so an effective and efficient working is possible. Last but not least we chose Shimadzu because of having a partner with great experience and reliable service not only in TOC analysis but other analytical techniques (IR, UV) that gives support in technical aspects, methods and qualification. We have a service contract in place like for other analytical equipment.
Summary description of the TOC Analyser in QC
Model: Shimadzu TOC-L CPH (see figure 1)
Type: combustion type analyser
Software: compliant to 21 CFR Part 11 (FDA)
Use of normal or sensitive catalyst, analysing down to a limit of detection in ppm to ppb range*
Autosampler ASI-L for effective and efficient working
Automatic sample acidification/sparging
Automatic dilution function (if the TOC content is too high for direct measuring)
*ppm = parts per million (10-6), ppb = parts per billion (10-9)
Figure 1Actual TOC Analyser (right) with Autosampler (left)
Figure 2TOC Analyser with SSM-5000A (solid sampler module)
Figure 3Sampler for simultaneous analysis of TOC and Nitrogen
Figure 4Shimadzu TOC-V system (wet chemical oxidation)
TOC Analyser in Quality Control
There are other variable accessories and kits for each type of application e.g. solid sampler module SSM-5000A (see figure 2), simultaneous analysis of TOC and Nitrogen (see figure 3), wet chemical oxidation (see figure 4).
Tillotts Services will be located at Exhibition Stand 25. Please come and visit us.
25 September 2012
Biotech Outsourcing Strategies 2012London, UKPlease come and visit us on stand 25 For more information please visit: http://www.bio2bevents.com
9 – 11 October 2012 CPhI Madrid, SpainPlease come and visit us on stand 10A93 For more information please visit:http://www.cphi.com
14 - 18 October 2012
aapsChicago, USAFor more information please visit:http://www.aaps.org/annualmeeting/
www.tillotts.com
We are delighted to present you with our third quarterly 2012 newsletter which we hope you enjoy. Within our technology section we profile our TOC Analyser which is a key piece of kit within our QC department. We also report on our recent presentation at the Biotech Outsourcing Strategies meeting in Copenhagen. Finally we provide details of our forthcoming conference and exhibition attendance along with our staff interview.
This month we were invited to present a paper at the “Biotech Outsourcing Strategies” CMC conference in Copenhagen entitled, “Lipid Self-Dispersing Formulations to Improve Biopharmaceutical Properties of Weak Soluble Compounds”. This is becoming an increasingly important area as evidenced by a continued increase in poorly water soluble compounds coming through early development.
With respect to our own technology focus within liquid-fill encapsulation using two-piece, hard-shell capsules, the development of lipid-based oral drug delivery formulations is primarily driven by the desire to increase and/or make reproducible the oral bioavailability of poorly aqueous soluble molecules. These typically exhibit erratic and variable pharmacokinetic profiles after the oral administration of conventional solid forms. Lipid-based formulations range from simple oily solutions to complex mixtures of oils, surfactants, co-surfactants and co-solvents, classified as lipid self-emulsifying (SEDDS) or micro-emulsifying drug delivery systems (SMEDDS). Due to their ability to maintain the active molecule dissolved and/or to prevent precipitation in vivo, self-dispersing lipid formulations are of high pharmaceutical interest for improving biopharmaceutical properties of active molecules. Our presentation gave an overview of the development methodology of lipid self-dispersing formulations for hard shell capsules, covering important bio-relevant in vitro tests for assessing the formulation performance.
Within Tillotts Services, we have the state of the art instruments and equipment available from early development up to large scale industrial manufacturing, as such we can offer a “one-stop-shop” approach from early pre-clinical development through to commercial manufacture and supply.
Summary of Benefits for a Lipid-based approach:
Lipid Self Emulsifying Formulations represent a powerful approach to increase solubility and oral bioavailability of poorly soluble drugs
SMEDDS should be tailor-made developed for the corresponding active compound (not “as general model-formulation or formulation kit”)
For BCS class II compounds, an early investigation of the lipid formulation approach is advisable for the satisfactory drug product development
In vitro bio-relevant tests should be considered in pharmaceutical development and as basis for in vitro – in vivo predictions (i.e. dispersion in simulated gastrointestinal fluids and lipolysis test)
For a copy of our presentation please contact Miriam Adler, Marketing Assistant Tel. +41 61 935 2804
If you want further details of how we can help, please contact Claudio Scialdone, Senior Manager Contract Services & Business DevelopmentTel. +41 61 935 2840
Issue 6
NEWSLETTER
Acknowledgements: Design by David Anthony, AK Design (Scotland) Ltd.
For more information, please contact us at:
Q: So Sarah please tell us a little about yourself?
A: I was born in Germany where I completed an apprenticeship as a “Chemical Technician Assistant”. During the last 6 years I have lived in Switzerland. Initially I worked as a Lab-Technician at MDS Pharma Services in Zurich. After that I moved to Basel, and worked for a range of life science companies so I have been lucky to develop a range of experience which I can now apply at Tillotts Services.
My hobbies are mountain biking, dancing (Standard/Latin and Lindy Hop) and spending time with my boyfriend.
Q: When did you join Tillotts?
A: I joined Tillotts as a Lab-Technician in the Quality Control in September 2010.
Q: What is your role within Tillotts?
A: Within my current role I analyse and evaluate the samples from our production department and report back the results. I also manage the ordering of chemicals for the Lab, and write the Analytical Report. However my role is about to change.
Q: What was the biggest challenge for you at Tillotts?
A: I have enjoyed the challenge of managing a diverse and complex workload that now includes a secondment to Quality Assurance.
Q: What will be your next big challenge at Tillotts?
A: My next bigger challenge will be my move from Quality Control to Quality Assurance. In the future I will undertake the approval of all GMP-Documents at our Ziefen facility such as SOPs/working instructions or deviation reports. The biggest challenge for me will be to learn more about our GMP-System. For the future it means that I still work with the Quality Control but also with all other departments in Ziefen.
Q: Of which project are you most proud?
A: I’m proud of the new ordering system for our laboratory chemicals which facilitates good stock control and on-time delivery from our suppliers.
In this edition Miriam Adler interviews Sarah Lutz, Lab Technician 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 2012. We would be delighted to meet with you.
Let’s Have Coffee..
Biotech Outsourcing Strategies cmc - Copenhagen
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.
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