Successfully reported this slideshow.
We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. You can change your ad preferences anytime.

170928 Presentation BioConnection (SMB meeting)

48 views

Published on

Presentation by BioConnection at the SMB meeting of september 28th on Novio Tech Campus

Published in: Health & Medicine
  • Be the first to comment

  • Be the first to like this

170928 Presentation BioConnection (SMB meeting)

  1. 1. C M C Alexander Willemse CEO BioConnection Chief Executive Optimist
  2. 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. 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. 4. OUR BUILDING BLOCKS CLIENT
  5. 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. 6 40 1 2 4 SERVING CLIENTS WORLDWIDE Since 2005 1
  7. 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. 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. 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. 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. 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

×