Biopharmaceutical_21x21_001

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Biopharmaceutical Facilities



This prospectus describes three examples of typical

biopharmaceutical facilities. The aim of the prospectus

is to give an overview of investment cost, time schedul-

ing and capacity for biotech projects and to be a source

of inspiration for your new facility.

The three examples of biopharmaceutical API facilities

are:

Development Laboratory with small-scale fermentation

and purification of new processes as well as production

of APIs for performing clinical trials in phase I and II.

Pilot Plant for the development and up-scaling of

processes as well as product manufacture for clinical

phases II and III.

Production Facility for large-scale production of bio-

pharmaceutical APIs.

The examples in the prospectus are completed projects

with minor changes to make the examples more general.

The prospectus looks at size, layout, capacity, investment

cost and legislation.

Contents

Development Laboratory

Pilot Plant

Production Facility

Biotech and Legislation in

Copenhagen

2



3



Seed lab.

Office

In-processlab.

Generalstorage

Generalmicrobiology

lab.

HPLC

room

Generalchemistry

lab.

Clean steam

Purified water treatment

Compressedair handling

Waste treatment

Electric boards

Available Storage

Laboratories

Reporting office

Reception

Canteen

LaboratoriesWeighing

and storage

Samplereceipt and

storage

Manager

Secretary

Office

Office

Media preparation Rest area

Meetingroom

OfficeOffice

Cold storage Autoclave

Cell culture

Purification

Basement

First floor

Second floor

Third floor

Administration

Cell bank

Utensilwashing

4



Laboratory for Development

and Clinical Trials

Total area 4,000 m2 / 42,000 ft2

Administration 1,000 m2

Laboratories 1,000 m2

Pilot Plant 2,000 m2

Fermentation

2 x 50-litre reactors, 6 x 10-litre reactors

Downstream processing

4 steps to accommodate the above reactors

Capacity

100-1,000 g protein per year

with a fermentation yield of 50-100 mg/l

All utilities included

Electrical power

WFI

CIP

Pure steam, etc.

Other functions

Administration

Laboratories

Development Laboratory Total investment cost (excl. cost of land)

USD 10 million – 2002

5



Basement

First floor

Second floor

Comp. air

Maintenance Change room

Storage

Media prep.

Fermentation hall

Inactivation

Cooling Water treatment

CIP system

Storage andreceipt/dispatch

Media prep.

Laboratories Administration

Control room Utensil washing

Capture& purificationFermentation hall

Small-scale pilot plant

6



Pilot PlantTotal investment cost (excl. cost of land)


Pilot Plant Facility for Process Improvement,

Up-scaling and Clinical Trial Production

Total area 4,200 m2 / 44,000 ft2

Pilot 1,500 m2

Laboratories 600 m2


Utility and storage 1,000 m2

Equipped with

Cell bank

1 x 2,500-litre fermentor

3 x 500-litre fermentors


Flexible 4-step multi-purpose purification

to accommodate fermentation output

Capacity

20-150 kg protein per year

with fermentation yield of 200-400 mg/l

All utilities included

Power

CIP

Pure steam

WFI

Cooling

HVAC

Other functions

Administration

Laboratories

7



Overview Production

Utility center (WFI, clean steam, CIP)

Energy center

A d m i n i s t r a t i o n / L a b o r a t o r i e s

Purification

Fermentation

Heating

Compressed aircooling

8



Facility for Large-scale Production

Total area 14,000 m2 / 150,000 ft2

Production 7,000 m2


Utility and storage 5,000 m2

Equipped with

2 x 5,000-litre reactors

2 x 500-litre reactors

4 x 50-litre reactors


4 steps in 2 separate lines to accommodate

the above reactors

Capacity

400-800 kg protein per year with

fermentation yield of 500 mg/l

All necessary utilities

Power

CIP

Pure steam

WFI

Cooling

HVAC

Other functions

Administration

Canteen

Staff lockers

Maintenance

QC lab.

Production Facility Total investment cost (excl. cost of land)


9



Biotech in Denmark

Denmark has a long biotechnological tradition, which is a

prolongation of the agriculture’s historically very central

role, and which is also shown in the outstanding develop-

ment of the brewing culture in the 1800-century.

Presently, it is a Danish company that is the world’s

largest producer of industrial enzymes and this contributes

to the fact that generally the population appreciates and

accepts biotechnological companies – and trusts the com-

panies’ handling of the environmental consequences.

Copenhagen – at the Center of Medicon Valley

Copenhagen is located in the center of the cross-border

pharmaceutical and biotech cluster, Medicon Valley.

Medicon Valley is responsible for approximately 60% of the

Scandinavian pharmaceutical and medical industry. Medicon

Valley – which encompasses the Danish Capital Region Greater

Copenhagen and the Skåne region in southern Sweden – is the

largest pharmaceutical and biotechnological growth center in

Scandinavia and one of the strongest in Europe.

Medicon Valley employs around 41,000 full-time workers –

two thirds of them on the Danish side. The region is a leading

center in medico-technology and biotechnology thanks to its

extensive community of high-tech companies, modern labora-

tory facilities and world-class research.

The region holds a strong scientific position within this area in

Europe and hosts an impressive number of biotechnological,

pharmaceutical and medical device and service companies. The

companies established in the region form an industry that is

larger than the US biotech industry measured per capita.

10

FINLAND

AUSTRIA

ITALYSPAIN

SWEDENNORWAY

GERMANY

FRANCE HUNGARY ROMANIA

BULGARIA

DENMARK

POLAND BYELARUS

UKRAINE

CZECHREPUBLIC SLOVAKIA

GREECE

NETHER-LANDS

BELGIUM

IRELAND

SERBIA

ALBANIA

LITHUANIA

LATVIA

ESTONIA

LUX.

MONTENEGRO

BOSNIACROATIA

SLOVENIA

SWITZERLAND

MACEDONIA

U. K.

English Channel

Bay of Biscay

North Sea

Baltic Sea

Gulf of Bothnia

Tirane

Minsk

Sarajevo

Sofia

Zagreb

Prague

Copenhagen

Helsinki

Paris

Budapest

Rome

Riga

Vilnius

Skopje

Monaco

Amsterdam

Oslo

Warsaw

Bucharest

Bratislava

Madrid

Stockholm

Bern

Vienna

Brussels

Tallinn

Berlin

Dublin

Ljubljana

London

Denmark Sweden

Companies in the Region

Among the companies in the region are large pharmaceutical

groups such as Novo Nordisk, H. Lundbeck, AstraZeneca,

Leo Pharmaceuticals, Ferring and ALK-Abelló. The biotech-

nological sector is represented by companies like Pharmexa,

NeuroSearch, Active Biotech, Biora, HemeBiotech, Exiqon

and Pantheco.

Some of the American companies represented in Medicon

Valley are Genmab, Acadia Pharmaceuticals, Maxygen,

Structural Bioinformatics and Ciphergen.



Health Care

A strong and efficient health care system is a key factor behind

Medicon Valley’s concentration of medical companies. In

Medicon Valley’s 26 university hospitals there are 14,000 beds.

More than 14,000 physicians, 2,000 dentists and pharmacists,

and 20,000 nurses work in the region. All citizens have equal

and free of charge access to treatment, which makes the public

health services the best domestic market imaginable for the

medical industry.

Approval of Drugs

Traditionally, the Danish health authorities approve drugs and

the observation of GMP-rules is based on an open dialogue

with the producing companies.

The authorities have a pragmatic approach to disputed points

and an openness towards the industry’s input, which con-

tributes to following professional discussions all the way

through.

The drug manufacturer will be linked-up with a dedicated

drug inspector who will receive all requests regarding disputed

points concerning GMP-related matters and registration. In

many cases the request can be settled by phone – more compli-

cated questions in writing.

In EU a formalised collaboration exists between the European

countries’ drug inspectorates and here Denmark plays a very

active role in the development and interpretation of EU’s

GMP-rules. Denmark is thus up front when it comes to

knowledge of the trends and possible developments within the

GMP-area – a position, which the industry takes advantage of

in the collaboration with the inspectors.

11

Legislation in Denmark

Pharmaceutical companies are required to apply for permits

and authorizations from various authorities. The companies,

however, generally meet a flexible and efficient administration.

The municipalities in the area are very favourable to trade and

industry and it is a tradition to create a trustworthy collabora-

tion between companies and public administration.

The following are some of the most important permits and

authorizations which must be obtained;

Environmental Permits

Before obtaining a building permit, a pharmaceutical facility is

required to obtain an environmental permit through an envir-

onmental application.

Approval time is typically 9-12 months and approval is nor-

mally effected in a co-operation between the pharmaceutical

company and the engineering company.

Building Permits

Before starting excavations, the project requires a building per-

mit. After construction, the facility is inspected and approved

by the Building and Fire Inspector and the Health and Safety

Department for the issuing of an occupancy permit.

Manufacturing Authorization

After establishment, qualification and validation of a new

pharmaceutical facility, the facility is inspected and approved

by the health authorities for the issuing of a manufacturing

authorization.

The manufacturing authorization is obtained by submitting a

master file to the authorities, who then inspect the facility.



D e s i g n : N N E A / S , V i s u a l i z a t i o n . P r i n t : L i t o t r y k K ø b e n h a v n A / S . N o v e m b e r 2 0 0 3

This prospectus is an outcome of the collaboration

between Copenhagen Capacity and NNE A/S.

Copenhagen Capacity is a service agency for foreign

companies that are interested in locating in the region.

Moreover, Copenhagen Capacity strives to support the

region’s commercial development – and thereby con-

tributes to strengthening the role of Greater Copenhagen

as a center of international commerce and economic

growth.

NNE A/S is an engineering company specialised in engi-

neering consultancy to the pharmaceutical and biotech

industries. NNE A/S is the leading engineering company

for these industries in the region.

For further information on Medicon Valley visit

www.mediconvalley.com or contact Copenhagen Capacity.

NNE A/S

Krogshoejvej 55

DK-2880 Bagsvaerd

Denmark

Tel. +45 44 44 77 77

Fax +45 44 44 37 77

[email protected]

www.nne.dk / www.nne.biz

Copenhagen Capacity

Gammel Kongevej 1

DK-1610 Copenhagen V

Denmark

Tel.: +45 33 22 02 22

Fax: +45 33 22 02 11

[email protected]

www.copcap.com

All rights reserved. No part of this prospectus may be reproduced

in any form or by any means without a written permission from

either Copenhagen Capacity or NNE A/S.

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