C M C

Alexander WillemseCEO BioConnection

Chief Executive Optimist

E s t a b l i s h e d i n 2 005

Funded by Dutch governmentali n i t i a t i v e s ( 1 0 0 % )

YTD: solid customer base +proven business concept

Several ‘best-in-class’ EUmanufacturing partners

Located at the Life SciencesPark 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 COMPLEXP 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

12

4

SERVING CLIENTS WORLDWIDESince 2005

1

PROJECT DISTRIBUTION

Production &Development

Full service

Production

38%

33%

12%

17%

Markets

EU NL US ROW

(complex)small molecule

49%

Vaccine4%

Protein30%

Fusion protein2%

MAb4% 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 approvedTerminal sterilizationManual fill

Availablesizes

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 CornelissenBusiness Development ManagerE: Joost.cornelissen@bioconnection.eu

Dennis LinkBusiness Development ManagerE: Dennis.link@bioconnection.eu

Sjaak StevenseDirector Marketing & SalesE: Sjaak.stevense@bioconnection.eu

K l o o s t e r s t r a a t 95 3 4 9 A B O s sThe Nether lands

www.bioconnection.eu

B I O C O N N E C T I O N