page 1 private & confidential nextpharma technologies holding limited sterile product...

Private & Confidential

NextPharma Technologies Holding Limited

Sterile Product Development Centre (SPDC)

At Braine-l’Alleud, Belgium


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


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


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


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


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)


The SPDC Facility in 3D


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


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


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


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


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

page 1 private & confidential nextpharma technologies holding limited sterile product...

Documents

cyto gmp area

packaging slide

clinical area

private confidential

formulation area

cyto gmp batches

capacity slide

sterile products spdc