Fraunhofer IPT & Harro Höfliger—

From lab-scale to industrial production:
We automate your life science processes

Transformation of yourmanufacturing process for
medical and biological products
from the laboratory toprofessional industrial production

VISIONMISSION
We support you in the design ofyour system, taking into accountproduct relevant design
requirements and bring yoursetting up to industrial standards

—

The combination of the Fraunhofer IPT's research capabilities and Harro Höfliger's
industrial expertise will revolutionize life science production!

© Copyright

New therapies driven by a fusion of science and industry

The best of both worlds

We know how to keep your cells happy!

Harro Höffliger

Fraunhofer IPT

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Valley of tears in the ATMP development process
When should I automate my production?
At the end of the preclinical phase,when clinical trials are to begin, all
ATMP manufacturing processes
must be established
Design FreezeFrom Phase II onwards, manual
production is no longer costefficient due to the increased
throughput and is later no longer
feasible. The process must bechanged at great regulatory
expenseValley of Tears

In the long term, even a
subsequently partially automatedprocess does not achieve theproductivity of a production plantthat has been fully automated fromthe start

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Transforming Efficiency and Quality in Life Sciences Production
Increasing innovative strength and competitiveness

Cost savings

Quality & Consistency

 Lower personnel costs
 Lower COGs
 Increase product yield Standardization
 Minimization of human errorand bias

Traceability & Regulatory

Scalability

Documentation
 Process Data Management
 Process Digitalization

 Flexibility in Adaption
 Easier scaling

Automation as an enabler for next-generation productionin the life sciences industry

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Your journey with us, get on board!

New therapies driven by a fusion of science and industry

Process mapping

Automation
concept

Small scaleproduction

Up-Scaling

High Volumeproduction

 Need of automation
 Automation strategy
 Economic relevance Automation
Scenarios Implementation
strategy End-to-endautomation
 Fully digitalizedprocesses

 Scale upstrategy
 Transformationto industrial
standard

Fraunhofer IPT
Wherever you are, we help along the entire process
and production chain

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Large-scale,
fully
automated,industrial
production

Fraunhofer IPT - Research manufacturing platforms
Our current Projects

Stemcell
Discvoery

Page 8
7/4/2024
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Let's shape the future of your production together!

Provided by Fraunhofer IPT Research and Harro Höfliger Production Design Consulting

Engineering

Economics

Roadmap

Set up & ScaleYou are provided with
schemes and scaled 2D (or3D) drawings of the designed
production system including aparts list of all components.
This forms the technical basis
for commissioning theconstruction of a fully
automated production system.

Our profitability analysis
comparing manual andautomated production
processes provides you withwell-founded data proving thelucrativeness of an investment
into an automated production
system compared to themanual production.

At the end of our consulting,
we develop a detailed
roadmap for you, which
recommends the next steps tobe taken in order to lead yourproduction to full automation.

We build your fully automatedproduction system, or help
you to scale your current
system, using the latest
technologies and experts from
more than ten specialist
areas.

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Fraunhofer IPT Automation Consulting

Five building blocks for successful laboratory automation

EXPERIENCE DAY(ONSITE AT IPT)
Introduction to theautomation solutions
for stem cell
production
developed at theFraunhofer IPT

QUICK SCAN &PARTNER'S VISIONCURRENT STATEANALYSIS

SOP analysis andautomation feasibilityassessment

Economic andtechnologicalanalysis of thecurrent
manufacturing
process

POTENTIAL & GAP
ANALYSIS
Derivation of thepotential regarding
the automation ofthe considered
process

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ROADMAPPING &IMPLEMENTATIONSTRATEGY

Concrete
implementation
strategies for an
automated
production processHarro Höfliger

Offering from lab to production

Engineering

Economics

Roadmap

Set up & Scale

We have a three step design
approach from basic design,concept design including
packaging design and userrequirements development anddetailed design. Finalizing thesteps lead to manufacturing of
the machines and executing
the built of the equipment.

We can compare and leverage
manual and automatedprocesses in regard toinvestment, risk,
contamination control andcritical quality attributes of theproduct. After that, the results
are incorporated into the basic
design of the manufacturingsolution.

At the end of our basic design
engineering, we start defining
with you all the details of theproject, help on designing theURS and start into detailed
design, followed by the built
and commissioning of theequipment until the final
acceptance of the machines
together with our partners.

We build your manufacturingsystem from lab scale
applications to fully automatedcommercial production lines,
always offering the diverseand broad range of the Harroportfolio of 6 different
business units and 16
different market systems

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Harro Höfliger Portfolio Overview
Your product – our focus

ASSEMBLY TECHNOLOGIESPHARMACEUTICAL TECHNOLOGIES

Inhalation

CapsuleFilling &Weighing

Aseptic
Processing

Microneedles

Combination
ProductsWEB TECHNOLOGIES

Wound &Skin Care

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Ostomy &Continence
CareTransdermals& Oral Films

ParenteralDevice
Assembly

MedicalDevice
Assembly

NewTechnologies

PACKAGING TECHNOLOGIESEye CarePortionPacks

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Packaging

SurgicalSutures

Diagnostics

Aseptic Processing

Basic Information and Philosophies
Aseptic Technology Design Standards■ Driven by GMP Annex 1■ Harro Höfliger Aseptic Whitepaper – The design specification

for aseptic machines■ Hygienic design standards■ Covers, sealings, product contacts parts■ Materials, certificates, surface finishes■ Compatibility with cleaning & disinfection agents

Pharma Service & Engineering and Innovation
Services■ Proof of concepts■ Filling, assembly and sealing trials■ Active product analysis, lab and cleanrooms available■ Product handling and packaging for aseptic infeed (VHP /NTT…)

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Aseptic Processing

Basic Information and Philosophies
CFD Simulations■ Laminar airflow & turbulences■ First air contact■ Air velocities■ Pressure cascades & overflow into surrounding areas

Mock-up Sessions■ Aseptic set-up and preparation for VHP-Deco. &production■ Glove port positions, door sizes & hinge positions■ Environmental monitoring■ Reachability, Accessibility, Cleanability & Ergonomics

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Get in touch with us!

Louisa Weltin, M. Sc.
Research Fellow
Automation in Life Science
Tel. +49 241 8904 236
louisa.weltin@ipt.fraunhofer.de

22.05.2024 I Seite 15

Kai Janning, M. Sc.
Business Innovation Manager
Automation in Life Science
Tel. +49 241 8904 302
kai.janning@ipt.fraunhofer.de

Christian Kolleker, M. Sc.
Director Sales
Aseptic Processing
Tel. +49 7191 501 1594
Christian.Kollecker@hoefliger.de