Biopharma

MISSION

We offer unique and complete technological solutions to the leading local and global manufacturers in the Life Science industries. This way, we fulfil our commitment to the personal and professional growth of our employees in a challenging and demanding business environment, at the same time supporting the development of the local environment.

VISION

We want to become one of the leading global solution providers for unique process systems to Life Science Industries.

FACTS

• 40 years of experience in industrial process systems for Biopharmaceutical, Pharmaceutical and Food industry

• Family owned

• Located in Sora, 15 km north of Ljubljana, Slovenia

VALUES

Accuracy and expertise > QUALITY

Curiosity, excitement and sense of initiative > INNOVATION

Responsiveness, team work and multitasking > FLEXIBILITY

Fairness, respect, commitment and loyalty > RELIABILITY

• Staff: 400+, of whom more than 150 engineers

• 90% of entire profit is reinvested to the most demanding pharma markets

• More than 90% of process systems are exported

• Factory facilities total area: 20,000 m2

• Production, assembly & FAT testing area: 16,000 m2

• One of the largest manufacturers of biopharma skids in Europe

“ONE-STOP-SHOP” - BRINOX INTEGRATED TURN-KEY APPROACH

Faster time-to-market and first-class quality

Research & Development

Brinox offers fully integrated services from engineering and production to installation and qualification of first-class customised process systems.

Our customers benefit from this approach, which allows us to be more flexible, respond quickly to any changes during the project and ensure continuous quality control at all project stages.

All know-how and lessons learned are retained and cumulated under one roof which enables us to foresee potential risks during projects and react on time.

Documentation

Qualifications

Sales & Service

Project Management

Quality

Customer

On-Site

Installation

Costs

Lead Time

Process

Development & Integration

Process Design

Mechanical Design & Piping

FAT Testing

Manufacturing & Assembling

Production of Vessels

Automation & Electrical Design

BRINOX PROJECT LIFE CYCLE

A project team precisely defines the project scope with the exact production process, and assures implementation of all client requirements and engineering standards. As experts we also implement value engineering during process design, mechanical (3D) design, electrical design and automation.

The benefits of our project execution:

• Project lead time control � fast-track projects

• Faster time-to-market

• Manufacturing control with engineering competence from a single source

• Quality control and cost transparency

• Fast response to changes during project execution � flexibility.

High-tech manufacturing facilities and extensive skills enable us to design and manufacture first-class quality equipment, even for fast-track projects.

Our integrated turn-key approach gives us the flexibility to react to last-minute changes, even in the later stages of a project.

We implement quality control on critical points during design and production. Customers can be sure of proven quality and compliance of their purchased equipment or process system with factory acceptance tests (FAT), performed at Brinox or remotely, if required. After delivery and on-site installation, we execute or support commissioning and on-site qualification.

YOUR PROCESS...

PROCESS

PROCESS

...OUR EQUIPMENT

Microbial Bioreactors

Cell Line Bioreactors

Media and Buffer Preparation Process Vessels and Systems

• 10 L up to 30,000 L volume

• With top or bottom agitator

• With single or double mechanical seal agitator

• Automated CIP, SIP

• cGxP compliant

• Full control, PAT

• Fully customized

• Optionally with perfusion (ATF or TFF)

• From 10 L up to 20,000 L volume

• With magnetic agitator

• Automated CIP, SIP

• cGxP compliant

• Full control, PAT

• Fully customized

• Efficient mixing

• Automated CIP, SIP

• With media distribution

• System can be separated in technical and clean room area

• cGxP compliant

• Fully customized

• For biochemical and chemical reactions

• Vacuum systems

• Different mixing solutions available

• Double wall, half pipe or pillow plate

• cGxP compliant

• Fully customized

Filtration

Mobile Vessels Chromatography

Clean Utilites, CIP and COP Systems

• Microfiltration

• Ultrafiltration / Diafiltration

• Nanofiltration

• Depth filtration

• Using filter type by client choice

• Footprint adjusted to required space

• cGxP compliant

• Fully customized

• Batch chromatography

• With or without HETP test

• Slurry vesels

• For resin or membrane column

• Footprint adjusted to required space

• cGxP compliant

• Fully customized

• Volumes up to 1,600 L

• Different mixing solutions available

• Connection to a central CIP, SIP and DIP module

• Use of retractable washing heads for CIP

• Automated dosing of ingredients and weighing

• cGxP compliant

• Fully customized

• Water for injection

• Purified water

• Clean steam

• Pure gas system

• CIP skids

• Brinox Cleaning Systems

• Fully automated units

• Can be offered with storage and distribution.

• cGxP compliant

• Fully customized

OUR REFERENCES

Cell-line Upstream Process

PROJECT SCOPE:

• 4 x 150 L Seed bioreactor with perfusion

• 4 x 600 L Production bioreactor

• 4 x 1,800 L Media preparation system

• 2 x 750 L Harvest vessel

• 3 x CIP units

Microbial (Vaccine) Upstream Process

PROJECT SCOPE:

• 2 x 600 L Production fermenter

• 1 x 750 L Hold tank

• 1 x 500 L Media preparation tank

• 1 x CIP unit

Microbial (mAb Fragments) Upstream Process

PROJECT SCOPE:

• 1 x 200 L Seed fermenter system

• 1 x 3,000 L Production fermenter system

• 1 x 1,300 L Media preparation system

• 1 x 120 L Media preparation system

• 1 x 1,000 L Media hold vessel

• 1 x 75 L Acid vessel

• 1 x 3,000 L Harvest vessel

• 2 x Transfer panel

• 1 x Filtration skid

• 3 x CIP unit

16.6 m

15.1 m

5.1 m

Plasma Fractionation

PROJECT SCOPE:

• 2 x 9,000 L Precipitation system

• 2 x 3,200 L Precipitation system

• 3 x 1,500 L Precipitation system

• 3 x 1,000 L Precipitation system

• 3 x 3,500 L Buffer prep system

• 5 x CIP Units

mAb Downstream with Media Preparation

PROJECT SCOPE:

• 2 x UF/DF system with 200 L vessel

• 3 x Chromatography

• 1 x Column packing system

• 1 x 7,500 L DSP tank

• 3 x 2,000 L DSP tank

• 2 x 2,000 L Media preparation

• 1 x 200 L Media preparation

• 1 x 1,000 L Buffer vessel

• 1 x 1,000 L WFI vessel

• 3 x 200 L Mobile vessels with docking station

• 5 x CIP units

ADC Bioconjugation Process

PROJECT SCOPE:

• 1 x 600 L Bioconjugation system

• 1 x 5,600 L Conditioning system

• 1 x UF/DF system with 1,200 L vessel

• 2 x UF/DF system with 500 L vessel

• 1 x Chromatography system

• 1 x 150 L Vaccuum evaporation system

• 1 x CIP unit

Media & Buffer Super Skid

PROJECT SCOPE:

• 2 x 6,000 L Media preparation vessels

• 3 x 6,000 L Media hold vessels

• 2 x 2,500 L Buffer preparation vessels

• 5 x 2,500 L Buffer hold vessels

12 m

21,5 m

11.5 m

mRNA Process

PROJECT SCOPE:

• 2 x 3,000 L Buffer vessels

• 51 x 1,600 L Holding vessels

• 5 x 1,200 L Buffer vessels

• 10 x 800 L Buffer, quench and holding vessels

• 21 x 300 L Lipids, mRNA and holding vessels

• 7 x 50-150 L Formulation and holding vessels

GMP-compliant Cleaning Systems

Washing machines of several sizes, and automated cleaning concepts compliant to cGMP, FDA, EMA, and GAMP for different wash items:

• IBC containers

• Pallets

• Machine parts/tools for tableting and capsule-filling machines, packaging lines, format parts etc.

• Weighing tools and devices

• Flexible hoses

CIP Skids Battery

PROJECT SCOPE:

• 13 x CIP skid with 2 x 2,000 L vessels

Brinox d.o.o. Sora 21 1215 Medvode

Slovenia

T: +386 1 361 97 30

info@brinox.eu

Brinox Deutschland GmbH

Maria-und-Georg-Dietrich Str. 2 77652 Offenburg

Germany

T: +49 781 970 678 10 info@brinox.de

Brinox Innovations AG Poststrasse 14 6300 Zug

Switzerland

T: +41 41 727 81 50 info@brinox-innovations.ch

Brinox USA, Inc. 101 S. Tryon St., Suite 2700 Charlotte, NC 28280

United States of America

T: +1 704 898 3698 info@brinox-usa.com

Photo: © Marko Prezelj