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Page 1 | 28.10.2016 Intro Quasaar
GMP-SERVICES
Guided By Innovation And Efficiency
Page 2 | 28.10.2016 Intro Quasaar
Innovation and efficiency – Added Value Quasaar
SERVICE OFFER QUASAAR
Attractive pricing model
Comprehensive, state-of-the-art
analytical techniques
Large volume capacity, versatile
stability center
Certified cooperation, all systems
and processes under GMP
Project stage / R&D to GMP -
interface to be defined by each
customer project
Fast track from GMP to R&D
Special expertise in all types of
particulate systems
Quality control and analytical support
Batch release analysis (release by QP on demand / EU – Retest)
Analytical support
Stability studies – storage (analytical investigations on demand)
Stress – and compatibility testing
Formulation screening
QC for API, raw material and excipients
Technology transfer
Method optimization (incl. robustness investigations)
Method transfer – concepts for GMP
Validation & qualification, design & performance
Cleaning validation, transport validation
Design & Performance of risk analysis
Method development & implementation into regulatory environment
Special techniques / methods (among more)
Added Value Quasaar: characterization of all kinds of particulate systems
Material Science – physical-chemical methods
Microbiology, Synthesis, Process optimization in cooperation with partners
Further services (among more)
GMP-Archiving, storage of retention samples, transport logistic
QP Services, preparation/execution of audits
Consulting and training concerning quality management, quality assurance, etc.
Page 3 | 28.10.2016
Dr. Christoph Jacobs
Study of chemistry, PhD in pharmaceutical and medical
chemistry
> 15 years GMP expertise in an industrial environment
Head of the API expert team with a provider of analytical
services (Across Barriers GmbH)
Head of QC with set-up and expansion of the QC lab
(PHAST GmbH)
Highly experienced with audits by FDA, European or local
authorities
Expert in dissolution studies and many other QC -
methods
Regular expert speaker about analytical methods under
GMP requirements
Know-how Quasaar
Management team with expertise and competence
MANAGEMENT
Dr. Markus Limberger
Study of chemistry, PhD in pharmaceutical and medical
chemistry
> 15 years GMP expertise in an industrial environment
Focus on drug QA
Many fold project experiences from collaborations with
almost all renown research driven pharma companies
> 10 years Head of Technical Management of a GMP service
provider (PHAST GmbH), installation of GMP and QM
systems
Regular expert speaker about QA and pharma analytics,
member of the respective committee within APV (an industry
association)
Author of several related publications (GMP Berater Verlag)
Page 4 | 28.10.2016
All customer requests realizable
ANALYTICAL TECHNIQUES
Benefits Quasaar
• Several redundant HPLC/UPLC stations
• All common methods realizable
• Technical upgrades and additional capacity on
demand
• Detectors: UV-VIS, PDA, refractive index
• Drug Release / Kinetics
• Paddle & Basket & special devices
• SUPAC studies
• Automated systems
• IVIVC
• Special dosage forms
• Biopharmaceutical characterization
• GC, GC-HS (residual solvent)
• (GC-MS / ICP-MS)
• Spectroscopy (UV, IR, fluorescence)
• Compendium methods (USP, EP, CHP
etc.)
• Water determination (Karl-Fischer etc.)
• volumetric/coulometric
• Oven method
• Pharmaceutical-technical methods• disintegration
• resistance to crushing
• friability
• appearance, opalescence, turbidity
• density, pH-value, osmolality
• leakage tests
• TOC-, TIC-Determination
• Special analytical methods for
investigation and characterization of
particles
Established base techniques in the analytical lab
Further techniques on request – can be realized based on a smooth internal GMP supply
yet within the still initial project activities
Page 5 | 28.10.2016
State-of-the-art outlay
Technical operations
efficient in design
All relevant climates
Capacity for small to big
units incl. as bulk ware or
on palettes
Easy scaling-up
500 m3 to be enlarged to
2000 m3
Extra warehouse for
retain samples
Up-coming:
500 m3 GMP-archive
Large and state-of-the-art capacity for stability
studiesSTABILITY CENTER
Available conditionsStandard / ICH climatic conditions
25°C/60% r.h. 280 m3
30°C/75% r.h. 180 m3
40°C/75% r.h. 50 m3
Refrigerator and freezer storage
-20°C ± 5 °C
5°C ± 3 °C
-80°C for special deep freeze samples
Available special conditions
25°C/40 % r.h.
30°C/65 % r.h
30°C/35 % r.h.
Cyclic conditions or transport validation
- 20 °C to 150°C
Benefits ÜberherrnTechnical characteristics
Redundant control systems for
temperature and humidity
Storage capabilities for palettes, barrels
or bulk ware
Protected against excess temperature
and humidity
Monitoring system Yokogawa
Alert system includes SMS & E-Mail
Benefits Quasaar
Page 6 | 28.10.2016
Characterization of particulate systems
SPECIAL KNOW-HOW ON PARTICLES
Bild S. 29 oben
Business Plan 24.03.2016
MJR PharmJet GmbH
Benefits Quasaar
*) EFSA: European Food Safety Authority
Methods for analyzing the particulate structure
Particle size (laser diffraction, Sympatec)
Zeta-Potential (Malvern)
Electron microscopy SEM / TEM (on request)
Particle counting, sieve analysis, Micro-Flow Imaging
and many more
Typical topics with particles
Particle size
Particle contamination, - count
Particle-based formulations
Particle size distribution
EFSA* threshold 100 nm
Agglomeration or disintegration, leakage
effects
Specific drug release profiles
Residual solvent in particulate systems,
elemental impurities
Encapsulation efficiency
Customized HPLC methods
Surface properties
and many more
Page 7 | 28.10.2016
How we collaborate with you
WORKING FOR OUR CUSTOMERS - I
GMP-Zertifikat
Quasaar
Built-up of collaboration
1. Agreed definition of basic concept for outsourcing cooperation
2. Ratification of secrecy agreement, exchange of relevant
documents
3. Quotation built on feasibility evaluation and compilation of
techniques and equipment to be used
4. Integration of all relevant GMP documents, ratification QAA /
service agreement
5. Audit
6. Definition of project team & time schedule plus capacity check
On-going collaboration
7. Installation of methods (if needed optimization & validation)
8. Sample logistic & storage of samples for stability tests
9. On-going work on tests and analysis
10. Certificates and stability reports, reporting of results to the
customers
11. Performance monitoring by KPI
12. Regular Jour Fixe with the customer team
Benefits Quasaar
Page 8 | 28.10.2016
IT safety and data communication within a project
WORKING FOR OUR CUSTOMERS - II
Benefits Quasaar
Data back-up
What will be backed up?
Analytical raw data and documents
Separate, Quasaar-exclusive server established
Commercial data and documents on separate ERP server
Where and when will be backed up?
Backup files: 2 times a day (12:00 / 16:00) to back-up server
Backup VMs: 1 times per day back-up server
Backup: analytical raw data and documents 1 times per week
on Blue-ray Disc
RawdataServer
FileServer
ERPServer
Back-upServer
Data transfer / communication
Technical data connection fiber optic network / internet
Up / Down synchronous lines 100-300 Mbit
Redundant connections to the fiber optic network
Direct entry of data into customer systems (LIMS, SAP)
Establishing local clients (IT) at Überherrn site
Archiving of relevant hardcopies in Quasaar system
Telecommunication: 8-24 parallel trunks (fiber optic)
Page 9 | 28.10.2016
Efficient Quality System guarantees GMP-compliant
workflows & proceedingsQA ELEMENTS QUASAAR - I
Benefits Quasaar
Quality Manual (QSH)
SMF, VMP, SOPs
Raw data, protocols, templates
Documentation
Change Management
Training
RiskManagement
Qualification
Validation
Deviation
Self inspection
Audits and inspections
Complaints
CAPA-Management
Lab evaluation,
Root cause analysis
OOX
(OOS, OOE, OOT, OOC)
Q
A
Page 10 | 28.10.2016
Quality Assurance, the basis for customer
satisfactionQA ELEMENTS QUASAAR - II
Benefits Quasaar
Elements QM - System
Document management
• All computerized systems are validated
acc. GAMP5
• Redundant data archiving
• Document system
• Quality Manual, SMF, VMP
• SOPs, testing specifications
• Raw data, protocols, templates
Deviation management established
• Traceability
• Central management by QA
GMP-compliant training & documentation
• Internal training
• External training
• Advanced training & education
• Surveillance
Risk management
• FMEA / FTA / Ishikawa
Qualification
Supplier & subcontractors
Equipment
Validation
• Methods
• Processes
• Computerized systems
Compliance with
regulatory requirements
Customer
satisfaction
Patient safety
Continuous
improvement
Product quality
Data integrity
Document management
Compilation
Steering
Distribution
Archiving
Sample monitoring
Registration
Storage
Stability
Qualification monitoring
Training
Supplier & subcontractors
CS and equipment
Regulatory guides
Audits und inspections
Deviation
Lab evaluation (root cause analysis)
OOX
Audits and self inspections
Customer complaints
CAPA-Management
Page 11 | 28.10.2016
Each project deserves specific attention
Project management
Customer orientation in outsourcing by Quasaar
Quasaar project management – embedded into the
customers project management
Long-standing experience with outsourcing
situations – gathered at both sides
Own management systems for continuous process
optimization
Highly qualified staff – including an own training
High dedication to deliver on time
Trusted relationships to authorities and customers
Interface development to GMP
Quasaar operates an established interface between
the GMP lab and the development lab
The Quasaar lab works within an environment for
pharma development
Well defined separation between development stage
and GMP
According to the customer needs
Development domain and GMP domain maintain
separate QM systems
Quasaar management highly experienced in GMP
Campus Überherrn provides further competencies to
lean on by a prolific network of partners
Highly flexible in the set-up of the desired test
design and the required documentation
Direct transfer of data into the customers IT systems
CHOICE BETWEEN GMP OR DEVELOPMENT STAGE
Benefits Quasaar
Page 12 | 28.10.2016 Know-how Quasaar
Topics for our customers - I
TYPICAL CUSTOMER PROJECTS
Maintenance and variations support, GMP and analytical support
Life Cycle Management "old methods" because of new regulatory requirements, check validation
documents - concept to update the validation (including robustness)
Comparative studies SUPAC for relevant changes in production/formulation (validation of the
relevant methods)
Scientific assessment concerning monograph methods (e.g. Chinese Pharmacopeia), planning
and implementation of relevant validation or verification activities
Compatibility tests drug / excipients, generic methods for evaluating, implementing studies with
small batches of the final dosage form (production of batches MJR-PharmJet)
Development of concepts for qualification, implementation and compilation of GMP-compliant
documentation
Stability and analytical support in development projects - project team consisting of R&D of the
customer, MJR PharmJet for formulation (particulate systems, small batch sizes) and Quasaar to
develop the relevant criteria (e.g. encapsulation efficiency, residual solvents, drug release etc.. )
and many more
Page 13 | 28.10.2016 Know-how Quasaar
Topics for our customers - II
TYPICAL CUSTOMER PROJECTS
Quality Control
Batch release analysis for finished products, active ingredients and excipients (full analysis,
reporting, certificate)
QC of raw materials incl. method optimization and validation of methods according to current
GMP requirements and transfer back to the customer (protocol & report, laboratory training)
Biopharmaceutical characterization and comparison of finished product (pH solubility profiles,
release profiles)
Qualification and auditing of suppliers
GMP-compliant quality control of excipients, risk-based approach validation of analytical methods
Stability
Storage of large-volume batches at ICH conditions (parenteral products, veterinary drugs, bulk),
creation of the GMP documentation stability (storage plans, cumulative stability reports)
Performing of stress tests to proof stability-indicating properties of analytical methods
Determination of shelf life for standard substances and reagents, qualification of standard
substances
and many more
Page 14 | 28.10.2016 Benefits Quasaar
Pricing differentiated by customer needs – Quasaar
solutions quite often more efficientPRICING
Hourly rates vary by
- Involvement of personnel
- Involvement of installed technical base
- Technical complexity
- Additional training & consulting
Examples of typical hourly rates
- € 95 base lab staff (pure documentation)
- € 100–125 (depending on equipment class)
- € 150 – 200 technical / academic experts
Quotations react on
- Individual project needs
- Individual customer needs
Pricing in the stability center
- Cost go by volume in units of 10 l
- Initial registration costs by time and effort
Attractive relation volume to cost
- due to large-volume climate chambers
- Suitable for high volume sku’s (incl. bulk)
- RFID-technology currently build-up
Prices for samples in the stability chambers
- € 0,80 – 1,0.- per l per month in standard
ICH-climate conditions
Quotations react on
- Individual project needs / customer needs
Analytical Laboratory Stability Center
Project performance based on KPITaylor-made pricing quotations on request
Page 15 | 28.10.2016 Know-how Quasaar
Scientific projects and a very competent network
ensure continuous innovationCOMPETENCE
Additional partner within a scientific
network – additional competence and
techniques
Mecadi GmbH
APV Arbeitsgemeinschaft, FG
Qualitätssicherung und Analytik
Technische Universität
Braunschweig
HTW Saarbrücken (Ibo-Institut,
Ri-Comet)
Helmholtz Institut (HIPS)
IBMT Fraunhofer, BioCryo
Synnovating GmbH
NanoBioNet
MikroBiologie Krämer GmbH
and more
Recent Publications Quasaar-Team
The Transfer of Analytical Procedures
Influence of X-ray as PAT-Method on Drug Products
GMP-Berater, Kapitel 14G Ergebnisse außerhalb der Spezifikation
(OOX-Ergebnisse)
GMP-Berater, Kapitel 14B Substanzen im Labor
In-situ Drug Release Monitoring with a Fiber Optic System
Partikelmessung von F&E bis GMP
GMP-Berater, Kapitel 14H Dokumentation im Labor
GMP-Berater, Kapitel Geräte im Labor (in Erstellung)
Recent scientific projects – often with competent partners
Development of new methods and techniques for determining and
predicting stability data (IBMT Fraunhofer)
Use of RFID technology in the pharmaceutical environment (Ibo Institute,
Ri-Comet)
Nano-formulations in the context of biological barriers (MJR-PharmJet)
Development of analytical instruments to test innovative dosage forms
Increasing efficiency in the laboratory environment (Synnovating AG)
Permeation and new methods for leakage testing for packaging materials
(Mecadi)
Page 16 | 28.10.2016 Innovation & Efficiency
Benefits Quasaar
Combination of flexibility and expertise in a regulated environment
Project team with many fold management experiences in outsourcing
GMP trained team
Well sufficient capacity in laboratory and stability center – further scaling-up possible
Definition of the interface between development stage and GMP according to customers
requirements
Seamless transfer of R&D results into the GMP domain
Analytical lab embedded into an environment for research and product development
Flow of samples and data in continuously optimized processes – and very efficiently
Sustainable quality ensured by integrated staff management and own training efforts
Handling of CTM (Clinical Trial Material), specific qualification/validation projects or teaming-up
within larger programs - as examples - available as service as well.
SUMMARY
Page 17 | 28.10.2016 Joint Know-how
The Campus in Überherrn
The commonly shared campus
at Überherrn is provided and
managed by Instillo GmbH.
Page 18 | 28.10.2016
The Überherrn premises
LOCATION / CAPABILITIES
Well located for logistics
D, F, Benelux within easy reach
5 min to motorway A 620, 10 min to A32/A4
(F)
40 min to Luxemburg airport
25 min to TGV/ICE
Paris – Saarbrücken - Frankfurt
Characteristics for the campus
12’000 m² total premises
5000 m² buildings
350 m² office space
1000 m² laboratory area –
further expandable
500 m3 stability center –
further expandable
Very modern energy concept
- photovoltaic arrays
- Batteries (also for safety reasons)
- Block heat and power plant
based on existing industrial premises.
Campus is operated by instillo GmbH.
Industrial area „Im Häsfeld“
Comotorstr. 2
Visitors: Industriestr. 1B
66802 Überherrn
Joint Know-how
Page 19 | 28.10.2016
State-of-the-art labs on the campus
CAMPUS ÜBERHERRN
GMP area of labs Quasaar
Development lab nanoSaar
Joint Know-how
Access to GMP area only via chip card control
Development lab MJR PharmJet
Page 20 | 28.10.2016
GMP area - clearly separated
CAMPUS ÜBERHERRN
Access control
- Chip system
- Restricted key list
Monitoring system to control room temperature
- Sensor system
- Fully closed rooms
Pest control at critical points
Stability Center
Office building
Reception
GMP lab QuasaarDevelopment lab nanoSaar
Utilities
GMP resp. Quasaar-domain
Joint Know-how
Development lab MJR PharmJet
Page 21 | 28.10.2016
Combined know-how on the campus and beyond
NETWORK OF COMPETENCIES
Including many fold external partner via the network of all companies on the campus
Joint Know-how
MJR PharmJet GmbH
CRO for pharma
Formulation development
for exacting substances –
with all suitable methods
Cooperation partner to
medtech companies
Application of the MJR
patents & technologies
in medtech
Quasaar GmbH
Outsourcing partner
QC & product control
Stability studies
Analytics & methods
Technology transfer
GMP-support
GMP-consulting
nanoSaar AG
Applications: Consumer,
non-Pharma and
cosmetics and other
Promotion of the
technology in specialty
chemicals & technical
applications
License models as well
as product supply on
choiceCompetence Center on the Campus Überherrn
Cost synergies
via the combined
group of
companies
Transfer of know-
how and
competencies
across the group
Fast track from
R&D to GMP
BEST OF 2016MIKROSYSTEMTECHNIK
MJR PharmJet also received the Gips-Schüle Award 2015 in Research: “Nano particles in the environment friendly production of solar cells”
nanoSaar also was a finalist (one of 4) with «Innovationspreis der Deutschen Wirtschaft 2016»
CPhI Pharma Awards
Winner 2014Best Innovation in Formulation
GMP-certified
2015
Page 22 | 28.10.2016
Contact
Quasaar GmbH
Dr. Markus Limberger
T +49 (6836) 9691 212
M +49 (162) 9677500
Comotorstr. 2
66802 Überherrn
www.quasaar.de
Your Partner in Outsourcing & Product Control
Dr. Christoph Jacobs
T +49 (6836) 9691 222
Company Run 2016