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C M C
Alexander Willemse
CEO BioConnection
Chief Executive Optimist
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)
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
OUR BUILDING BLOCKS
CLIENT
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
40
1
2
4
SERVING CLIENTS WORLDWIDE
Since 2005
1
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
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
BIOCONNECTION NEW CAPABILITIES
D-class process development room with state-of-the-art TFF equipment
Opened in 2017, suited
for development and GMP
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
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

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170928 Presentation BioConnection (SMB meeting)

  • 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
  • 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.
  • 7.
  • 8.
  • 10. 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
  • 11. 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
  • 12.
  • 13. BIOCONNECTION NEW CAPABILITIES D-class process development room with state-of-the-art TFF equipment Opened in 2017, suited for development and GMP
  • 14. 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
  • 15.
  • 16. 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