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Page 1 Private & Confidential
NextPharma Technologies Holding Limited
Sterile Product Development Centre (SPDC)
At Braine-l’Alleud, Belgium
Page 2 Private & Confidential
Benefits of the SPDC for You
• The SPDC can provide early and scale-up development for your sterile products
• SPDC can handle cytotoxic and biologics/conventional drugs in segregated units
• No site transfer involved during development of your product – which means less risk and resource
• Less risk as there is a seamless process from development through to commercialisation
Page 3 Private & Confidential
Benefits of the SPDC for You
• Expertise in lyophilisation
• Expertise in sterile formulation development
• An experienced development team transfers projects into commercial production.
• A wide range of packaging can be offered
• Global capability to service Europe, Japan, Canada, Brazil and USA (clinical)
• FDA compliance programme is in progress
Page 4 Private & Confidential
SPDC Sterile Product Handling Capabilities
Products OEL Biohazard Level
Capabilities Exclusions
Cytotoxics Level 4 N/A Solutions (aqueous & alcohols), emulsion, suspension and lyophilised drugs.
Solids
Biologicals Level 4 Level 2 Peptides, proteins, Mabs, deactivated vaccines, growth hormones
Live vaccines, live viruses, living organisms
Conventionals Level 4 N/A Solutions (aqueous), emulsions, suspensions and lyophilised drugs. Controlled drugs
Radiopharmaceuticals, Beta-lactams
Page 5 Private & Confidential
SPDC Packaging Capabilities
Products Packaging Capabilities
Cytotoxics Vials, pre-filled syringes, cartridges and kit assembly
Clinical trial supplies labelling and packaging
Biologicals Vials, pre-filled syringes, cartridges, ampoules and kit assembly
Clinical trial supplies labelling and packaging.
Conventionals Vials, pre-filled syringes, cartridges, ampoules and kit assembly
Clinical trial supplies labelling and packaging
Page 6 Private & Confidential
P . S . P . S .
P .S .
P . S .
The SPDC Facility
Cyto GMP Unit
Biologics / ConventionalGMP Unit
Storage and Final Packaging Area
2 QC Laboratories
2 Technical Development Labs
(Formulation)
Page 7 Private & Confidential
The SPDC Facility in 3D
Page 8 Private & Confidential
GMP Layout – Cyto or Biological/Conventional Units
Security lock - personal
Corridor
Pre-washing area
C Personal lock
Incoming material lock
Security lock - material
Large equipment installation lock
Sterilization area
Sterile material collection
Technical area
Compounding area
Filling area
B/C Personal lock –way out
Security lock
B/C Personal lock – way in
Material lock - dispatch Emergency exit
Decontamination area
Emergency exit
IPC
Documentation
Documentation
Page 9 Private & Confidential
GMP Layout – Cyto or Biological/Conventional Units
Washing machine
Packing after wash
Storage cabinets + large equipment storage
Depyrogenization oven (space for washing machine, tunnel)
Autoclave
Alcohol pass through
Hot air passthrough
Sterilizable (UV) passthrough
Passthrough
Compounding within RABS (Cyto)
Filling machine
Mobile 40 l vessel
Freeze dryer
Capping machine
Sterile filtration /compounding within RABS (Cyto)
Hand made decontamination and labeling
Storage cabinets (inc. cold storage)
IPC deviceMaterial handling trolley
Material handling trolley
Stepover bench
Fixed 40 l vessel
Storage cabinets (inc. cold storage)
Passthroughs
Emergency shower
Page 10 Private & Confidential
Scope of Activities
• The SPDC will serve all early phase development needs (to Ph 2) for CMC (Chemistry, Manufacturing, Controls) data and clinical materials
• The facility will be able to develop Cytostatic, Biologics and other non-Cyto parenteral drugs in lyophilised or solution forms
• Drug forms can to be packed in a wide range of packagings: vials, cartridges, pre-filled syringes etc
• The facility can also develop eye drops, nasal preparations and other sterile forms in various packaging forms
• Design capacity of the SPDC is 150 batches per annum, operating on 1 shift/8 hour, 5 day week basis
• Offering 50 cyto GMP batches, 50 biologics/conventional GMP batches and 50 technical formulation batches per annum
• Direct staff numbers in the SPDC facility will be 27 persons, operating as a business unit at full capacity
Page 11 Private & Confidential
Clinical Development Capabilities
Amongst the range of capabilities and activities to be done in each clinical area are:
• Cyto GMP area - has 1.6 m2 freeze dryer, capable of up to 2000 standard (20 ml) size vials
- has mix vessels of 0.4, 4 and 40 Lt, fully compliant with FDA and Thissen scale-up
- can fill vials, pre-filled syringes and cartridges
• Biologics/conventionals GMP area - has 1.6 m2 freeze dryer, capable of up to 8000 standard (5 ml) size vials
- has mix vessels of 0.4, 4 and 40 Lt, fully compliant with FDA and Thissen scale-up
- can fill vials, pre-filled syringes, cartridges and ampoules
- can prepare diluents for cyto and bio/non-cyto kits
Page 12 Private & Confidential
Formulation, Analytical and Other Capabilities
Amongst the capabilities and activities of the formulation and analytical areas are:
• Formulation area- has 1.3 m2 lyophiliser, capable of up to 1600 standard (20 ml) size vials- has mix vessels of 0.4, 4 and 10 Lt, installed in RABS (restricted access barrier
system) for cyto and bio work- can do pre-formulation work on cyto and bio, for compatibility, lyo cycles etc- can do preliminary work on filling of vials, pre-filled syringes and cartridges
• Analytical laboratories- full testing capability for biologics, cyto and non-cyto drugs- in-process test labs within cyto and biologics/conventional GMP areas- method development capability for biologics, cyto and conventional drugs- stability storage and testing capabilities, as part of Braine l’Alleud facility
• Other services- has full cold-chain handling capability for cyto and biologics drugs
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