GMP-SERVICES Guided By Innovation And Efficiency · Page 5 | 28.10.2016 State-of-the-art outlay...

| 28.10.2016 Intro Quasaar

GMP-SERVICES

Guided By Innovation And Efficiency

| 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.

| 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)

| 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

| 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

| 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

| 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

| 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)

| 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

| 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

| 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

| 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


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

| 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


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)

| 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

| 28.10.2016 Joint Know-how

The Campus in Überherrn

The commonly shared campus

at Überherrn is provided and

managed by Instillo GmbH.

| 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

| 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

| 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

| 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

| 28.10.2016

Contact

Quasaar GmbH

Dr. Markus Limberger

T +49 (6836) 9691 212

[email protected]

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

[email protected]

Company Run 2016

GMP-SERVICES Guided By Innovation And Efficiency · Page 5 | 28.10.2016 State-of-the-art outlay...

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