1.
C M C
Alexander Willemse
CEO BioConnection
Chief Executive Optimist

2.
E s t a b l i s h e d i n 2 0 0 5
Funded by Dutch governmental
i n i t i a t i v e s ( 1 0 0 % )
YTD: solid customer base +
proven business concept
Several ‘best-in-class’ EU
manufacturing partners
Located at the Life Sciences
Park in Oss (Pivot park)

3.
BRIDGING THE CMC GAP
Active Pharmaceutical Ingredient
Registration
Clinical Trials
Market
Discovery
Development
(formulation, lyo cycle,
analytics) &
validation
Clinical scale F&F
+ freeze drying
Stability
studies
Label &
pack
Commercial scale
F&F + freeze
drying

4.
OUR BUILDING BLOCKS
CLIENT

5.
SYNTHESIS & DEVELOPMENT OF COMPLEX
P A R T I C L E S
L I P O S O M E S
NANO-SUSPENSIONS
M I C R O S P H E R E S
LEADER IN CHALLENGING

6.
6
40
1
2
4
SERVING CLIENTS WORLDWIDE
Since 2005
1

7.
PROJECT DISTRIBUTION
Production &
Development
Full service
Production
38%
33%
12%
17%
Markets
EU NL US ROW
(complex)
small molecule
49%
Vaccine
4%
Protein
30%
Fusion protein
2%
MAb
4% Peptide
11%
API type

8.
CAPABILITIES
Batch size liquid product:
• 2 – 50 L (200L in flexbags)
Freeze-Drier:
• Shelf surface 1 x 3 m2
Fill volumes vials:
• 0.5 ml – 50 ml
Fill volumes syringes:
• 0.5 ml – 10 ml
• Luer lock, stack-needles etc
• Batch size: 5,000 syringes
per hour
FDA and EMA approved
Terminal sterilization
Manual fill
Available
sizes
Liquid product
in vials
Lyophilized
product
2 R DIN 12,500 11,000
6 R DIN 10,000 5,700
10 R DIN 10,000 4,800
20 R DIN 6,000 3,000
25 R DIN 6,000 3,000
50 ml 6,000 1,400

9.
BIOCONNECTION NEW CAPABILITIES
D-class process development room with state-of-the-art TFF equipment
Opened in 2017, suited
for development and GMP

10.
BIOCONNECTION NEW CAPABILITIES
C-class flexible GMP setup (fifth floor, open to changes)
- Small scale areas
- In-room A class isolator
- Handfill with freeze-dry capacity
- BSL-2 license for cell therapy
- Supported by trained operators
- Available for rental
- Estimated opening: Q1-2018 -> Development under D, GMP in C
Second filling line with enhanced capacity
- Tunnel approach instead of sequential manual process steps
- Estimated opening: 2019/2020

11.
CONTACT
Joost Cornelissen
Business Development Manager
E: Joost.cornelissen@bioconnection.eu
Dennis Link
Business Development Manager
E: Dennis.link@bioconnection.eu
Sjaak Stevense
Director Marketing & Sales
E: Sjaak.stevense@bioconnection.eu
K l o o s t e r s t r a a t 9
5 3 4 9 A B O s s
The Netherlands
www.bioconnection.eu
B I O C O N N E C T I O N