Transcript SPDC marketing

NextPharma Technologies Holding Limited
Sterile Product Development Centre (SPDC)
At Braine-l’Alleud, Belgium
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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
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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
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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
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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
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The SPDC Facility
Cyto GMP Unit
2 Technical
Development Labs
(Formulation)
P. S.
2 QC Laboratories
P. S.
P. S.
P .S .
Storage and Final
Packaging Area
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Biologics / Conventional
GMP Unit
Private & Confidential
The SPDC Facility in 3D
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Private & Confidential
GMP Layout – Cyto or Biological/Conventional Units
Large equipment
installation lock
Pre-washing area
Emergency exit
Sterilization area
Security lock personal
Sterile material
collection
Documentation
Technical area
C Personal lock
Compounding area
Filling area
Incoming material
lock
B/C Personal lock –
way out
Corridor
Security lock
Security lock material
Material lock dispatch
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B/C Personal lock –
way in
Decontamination
area
IPC
Emergency exit
Documentation
Private & Confidential
GMP Layout – Cyto or Biological/Conventional Units
Storage cabinets +
large equipment
storage
Depyrogenization
oven (space for
washing machine,
tunnel)
Hot air
passthrough
Washing machine
Packing after wash
Autoclave
Passthroughs
Alcohol pass
through
Compounding
within RABS (Cyto)
Storage cabinets
(inc. cold storage)
Sterile filtration
/compounding
within RABS (Cyto)
Fixed 40 l vessel
Material handling
trolley
Filling machine
Mobile 40 l vessel
Freeze dryer
Stepover bench
Capping machine
Sterilizable (UV)
passthrough
Emergency shower
Material handling
trolley
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IPC device
Storage cabinets
(inc. cold storage)
Private & Confidential
Passthrough
Hand made
decontamination
and labeling
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
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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
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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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Private & Confidential