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TECHNOLOGY
CAPABILITY OVERVIEW

BSP PHARMACEUTICALS OFFERS A WIDE RANGE OF ORAL SOLID AND STERILE INJECTABLE DOSAGE FORMS FROM THE EARLY STAGES OF FORMULATION DEVELOPMENT THROUGH PRODUCT COMMERCIALIZATION IN ORDER TO FIT THE NEEDS OF ITS CLIENTS.

conventional special capabilities
ORAL SOLIDS

BSP Pharmaceuticals has capabilities to manufacture conventional and special oral solid formulations on development an, clinical and commercial scale:

capabilities

AMONG ITS ORAL SOLID TECHNOLOGIES,
BSP OFFERS

  • BLENDING OF POWDERS AND GRANULATES
  • WET GRANULATION, AQUEOUS AND ORGANIC SOLVENT BASED
  • ROTO GRANULATION (WET GRANULATION ONE WAY; LAYERING; WET GRANULATION WITH API SOLUTION)
  • DRY GRANULATION BY ROLLING COMPACTOR
  • TABLETTING
  • ENCAPSULATION
  • BANDING
  • LIQUID FILLING OF HARD GELATINE CAPSULES
  • FILM COATING, AQUEOUS AND ORGANIC SOLVENT BASED
  • DEDUSTING / METAL CHECK
  • WEIGHT SORTING
DEVELOPMENT SCALE FROM 200g TO 500g
GMP MANUFACTURING SCALE FROM 4g TO 80-100g

Secondary packaging for oral solid forms includes blisters with components such as ALU-ALU; PVC/PVDC and bottling both for tablets and capsules.

A team dedicated to oral solid dosage forms supports the projects at all stages with suitable equipment and analytical instruments specifically designed for the scale up of development processes to the GMP area.

liquid
LIQUID FILLED HARD GELATINE CAPSULES

IT IS A SPECIAL CAPABILITY FOR HIGH POTENT ANTICANCER
PRODUCTS WITH LOW SOLUBILITY AND LOW BIOAVAILABILITY.
CAPSULES CAN BE FILLED WITH DISPERSION OR SOLUTION OF
THE API IN AN OILY BASED FORMULATION.

EQUIPMENT

ORAL DEPARTMENT

INJECTABLE
DOSAGE FORMS

STERILE DEPARTMENTS ARE EQUIPPED TO MANUFACTURE STERILE LIQUIDS AND LYO PRODUCTS.

Primary packaging for sterile dosage forms covers vial dimensions from 2 ml up to 100 ml.
All sterile departments have a system for filling liquid and lyophilized products, as well as oxygen-sensitive products.
BSP can handle liquid or lyophilized lipid-based formulations, such as emulsion and suspension, by using special technologies and equipment, including:

  • MICROFLUIDIZER
  • HIGH PRESSURE HOMOGENIZER
  • EXTRUSION
  • HEAT EXCHANGERS
STERILE 1

THE STERILE 1 PRODUCTION AREA IS DEDICATED TO THE MANUFACTURING OF LIQUID
AND LYOPHILIZED VIALS FOR CLINICAL AND COMMERCIAL BATCHES.

The FILLING LINE is fully automated and allows the manufacturing of batch sizes from 20L to a maximum of 250L.

VIAL SIZES range from 2ml to 100ml.

The FILLING OPERATIONS are performed by a combined dosage system equipped with volumetric rotary piston pumps and peristaltic pumps, with four filling needles, automatic non disruptive in-line weight check system.

THE LINE is installed under cRABS to assure high containment.

MANUFACTURING OF LYOPHILIZED PRODUCTS is carried out by two cryogenic freeze driers of 10sqm each, explosion proof, with automatic loading and unloading system (ALUS System).

THE LINE is equipped with two external vial washing machines.

STERILE 2

THE STERILE 2 PRODUCTION AREA IS DEDICATED TO THE MANUFACTURING OF LIQUID AND LYOPHILIZED VIALS FOR small scale CLINICAL AND COMMERCIAL BATCHES.

The FILLING LINE is automatic low speed and allows the manufacturing of batch sizes from 2L to a
maximum of 100L.

VIAL SIZES range from 2ml to 100ml.

The FILLING OPERATIONS are performed by a peristaltic dosing system.

THE LINE is installed under isolator (sterilized in-situ by using VHP) to assure a high containment and the protection of the operators and the product.

MANUFACTURING OF LYOPHILIZED products is carried out by cryogenic freeze drier 1.5 sqm, explosion proof.

THE LINE is equipped with an external vial washing machine.

STERILE 3

THE STERILE 3 PRODUCTION AREA IS DEDICATED TO THE MANUFACTURING OF LIQUID AND LYOPHILIZED VIALS FOR COMMERCIAL BATCHES.

The FILLING LINE is fully automated and allows the manufacturing of batch sizes from 40L to a maximum of 650L.

VIAL SIZES range from 2ml to 100ml.

The FILLING OPERATIONS are performed by a combined dosage system equipped with volumetric rotary piston pumps and peristaltic pumps, with eight filling needles, automatic non disruptive in-line weight check.

THE LINE is installed under cRABS to assure high containment.

MANUFACTURING OF LYOPHILIZED products is carried out by two cryogenic freeze driers of 30 sqm each, explosion proof, with automatic loading and unloading system (ALUS System).

THE LINE is equipped with two external vial washing machines.

STERILE 4

THE STERILE 4 PRODUCTION AREA WILL BE DEDICATED TO THE MANUFACTURING OF LIQUID AND LYOPHILIZED VIALS FOR COMMERCIAL BATCHES.

The FILLING LINE is fully automated and allows the manufacturing of batch sizes from 20L to a maximum of 400L.

VIAL SIZES range from 2ml to 100ml.

The FILLING OPERATIONS are performed by a combined dosage system equipped with volumetric rotary piston pumps and peristaltic pumps, with six filling needles, 100% automatic non disruptive in-line weight check.

THE LINE is installed under cRABS to assure high containment.

MANUFACTURING OF LYOPHILIZED PRODUCTS is carried out by two cryogenic freeze driers of 20sqm each, explosion proof, with automatic loading and unloading system (ALUS System).

THE LINE is equipped with two external vials washing machines.

STERILE 5

THE STERILE 5 PRODUCTION AREA WILL BE DEDICATED TO THE MANUFACTURING OF LIQUID AND LYOPHILIZED VIALS FOR COMMERCIAL BATCHES.

The FILLING LINE is fully automated and allows the manufacturing of batch sizes from 20L to a maximum of 400L.

VIAL SIZES range from 2ml to 100ml.

The FILLING OPERATIONS are performed by a combined dosage system equipped with volumetric rotary piston pumps and peristaltic pumps, with six filling needles, 100% automatic non disruptive in-line weight check.

THE LINE is installed under cRABS to assure high containment.

MANUFACTURING OF LYOPHILIZED PRODUCTS is carried out by two cryogenic freeze driers of 20sqm each, explosion proof, with automatic loading and unloading system (ALUS System).

THE LINE is equipped with two external vials washing machines.

STERILE 6

THE STERILE 6 PRODUCTION AREA WILL BE DEDICATED TO THE MANUFACTURING OF LIQUID AND LYOPHILIZED VIALS FOR COMMERCIAL BATCHES.

The FILLING LINE is fully automated and allows the manufacturing of batch sizes from 20L to a maximum of 250L.

VIAL SIZES range from 2ml to 100ml.

The FILLING OPERATIONS are performed by a combined dosage system equipped with volumetric rotary piston pumps and peristaltic pumps, with six filling needles, 100% automatic non disruptive in-line weight check.

THE LINE is installed under cRABS to assure high containment.

MANUFACTURING OF LYOPHILIZED PRODUCTS is carried out by two cryogenic freeze driers of 6 sqm each, explosion proof, with automatic loading and unloading (ALUS System).

THE LINE is equipped with two external vials washing machines.

injectable clinical commercial
CONJUGATION

BSP PHARMACEUTICALS IS SPECIALIZED TO SUPPORT THE MANUFACTURING OF ADC DRUG PRODUCTS FROM THE CONJUGATION TO THE FILL FINISH.

Manufacturing lines, process flows as well as storage capabilities have been specially designed taking into consideration the critical process parameters and the risk factors associated with the handling and production of this class of compounds.

DEVELOPMENT & GMP MANUFACTURING

banner development scale
DEVELOPMENT SCALE FROM 100mg TO <2g
GMP MANUFACTURING SCALE FROM 4Kg TO 4Kg +
  • Multiple buffer vessel configuration from 50 lt up to 10,000 lt capacity in order to support DF steps for applications and processes
  • Jacketed process vessels with stirring systems both designed to reduce thermal and mechanical stress during manufacturing steps
  • Buffer and process vessels can be cleaned and sterilized in place
  • Diafiltration systems can host most of the commercial cartridges/cassets systems suitable for development, clinical and commercial scale
  • Bottle filling machine equipped with a peristaltic dosing system to fill BDS in a wide range of primary packaging components (i.e. bottles with different capacity, bags or cryo-vessels)
  • Filling machine installed under isolator to assure high containment and the protection of the operators and the product
  • Operations performed in a "class C" area
  • Dedicated cold storage areas for BDS, monoclonal antibodies, toxin and finished product (+2/+8°c; from -20°C up to -80°C)

ANALYTICAL SERVICES

Dedicated capabilities are installed to support ADC characterization and manufacturing activities (IPCs as well as full release of the product). A specific area of the QC lab has been fully assigned to cytotoxicity studies to carry out testing on determination of ADCs potency.