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SERVICES
GENERAL OVERVIEW
A ONE-STOP-SHOP
IN THE PHARMACEUTICAL SUPPLY CHAIN

BSP is a Contract Development and Manufacturing Organization focused on production of anticancer and cytotoxic drugs as small molecule products and more innovative drugs, like proteasome inhibitors, ADCs (conjugation and fill/finishing), lipid-based formulations (nano and micro-emulsions, liposomal formulations), from Development to Clinical and Commercial Supply.

DEVELOPMENT SERVICES
CLINICAL SUPPLY
COMMERCIAL SUPPLY
DEVELOPMENT SERVICES
A STRATEGIC BUSINESS FRAME

The laboratories for formulations and process development are conveniently situated in the production area of the plant. Our specialists have the knowledge and training on the plant equipment and production requirements to reduce the risks of scale up failure.

OUR FACILITY PROVIDES WORLD-CLASS SERVICES FOR THE DEVELOPMENT
OF CONVENTIONAL AND INNOVATIVE DOSAGE FORMS.
 
preformulation studies
 
dosage form selection
 
compatibility studies
 
cleanability studies
 
stability
 
formulations, process optimization and scale up
 
analytical method development and validation

The pharmaceutical dosage forms
prepared by our development labs are:

ORAL SOLID oral solid
INJECTABLE injectable
CLINICAL SUPPLY SERVICES
WE MOVE WITH SCIENTIFIC RESEARCH

BSP OFFERS A HIGH LEVEL OF EXPERTISE TO SUPPORT THE MANUFACTURING OF CLINICAL PRODUCTS FROM PHASE I TO PHASE III.

The versatility of our plants allows us to easily transfer processes that are suitable for scale-up and scale-down on automated equipment.

CLINICAL MANUFACTURING SERVICES
COMMERCIAL SUPPLY SERVICES
RELIABILITY IN SUPPLY

THE PROCESS ROBUSTNESS AND THE ACCURACY OF A TECHNOLOGY TRANSFER ARE THE BASIS FOR A HIGH QUALITY PRODUCT.

The Client can choose from a vast range of dosages: from the conventional pharmaceutical form in lyophilized vials, vials with aseptic liquid filling and final sterilization upon request, tablets and capsules, to the high technology pharmaceutical dosage form, like the liquid filled hard gelatine capsules with the ADC (conjugation and fill/finish) products, the lipid based and biological solvent based formulations.

Commercial Supply Services
ANALYTICAL SERVICES
QUALITY CONTROL LABORATORIES

The objective of BSP is to deliver results that meet the requirements of global regulatory health authorities.
The facility houses chemical, biochemical and microbiological laboratories for the following typologies of analyses:

  • analytical methods transfer/validation
  • product release testing and stability
  • cleaning controls
  • environmental monitoring
  • raw materials testing in compliance with cGMP
CHEMICAL LABORATORIES
QUALITY CONTROL

The Quality Control chemical lab supports the cGMP manufacturing of Clinical and Commercial anticancer drug products
with the following activities:

  • analytical methods transfer
  • ICH compliant method validation
  • In Process
  • product release and stability testing
  • cleaning methods development and validation
  • raw materials testing

A wide range of analytical instruments enables the laboratory to run tests such as:

  • identification and assay
  • organic impurities and residual solvents
  • inorganic impurities
  • physicochemical characterization
  • osmolality and osmolarity

Stability and photostability studies are performed according to ich conditions:

climate chamber
CLIMATE CHAMBER PARAMETERS
25°C;/60%RH | 30°C;/65%RH | 30°C;/75%RH | 40°C;/75%RH | PHOTOSENSITIVITY
MICROBIOLOGICAL LABORATORIES
QUALITY CONTROL

Providing assays suitable for regulatory submission aligned with several regulatory agency requirements and equipped to
carry out tests, such as:

  • analytical methods validation
  • product release testing and stability
  • Environmental Monitoring
  • Cleaning controls
  • cleaning methods development and validation
  • Raw materials testing in compliance with cGMP

Our microbiological laboratory supports the following testing:

  • Bioburden
  • Sterility
  • Bacterial Endotoxins

BIOCHEMICAL LABORATORIES
QUALITY CONTROL

The biochemical laboratory has experience in establishing, validating and conducting routine bioassays according to cGMP standards.
Fully validated assays suitable for regulatory submission are provided.

Characterization work includes the determination of physicochemical and structural properties, purity, impurities and quantity of the monoclonal antibody, in line with ICH Q6B.

The main services offer comprises:

  • Method Transfer
  • ICH compliant Method Validation
  • Biopharmaceuticals Product Release Testing
  • END-POINT BINDING MEASUREMENTS
  • ABSORBANCE/FLUORESCENCE MEASUREMENTS
biochemical test
THE BIOCHEMICAL TESTS PERFORMED
TO DETERMINE PHYSICOCHEMICAL
PROPRIETIES ARE:

Molecular weight or size
Specific cytotoxicity assay
Isoform pattern
Extinction coefficient
Electrophoretic patterns
Liquid chromatographic patterns