BSP Pharmaceuticals

COMPANY PROFILE

BSP Pharmaceuticals S.p.A. is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end pharmaceutical services for both oncological and non-cytotoxic innovative drugs.

Description

BSP Pharmaceuticals is a CDMO, technologically developed to meet needs of groundbreakers and specialized in manufacturing Oncology and Immunotherapy drug, including autoimmune disease, immunotherapy & CNS among others, with a strategic interest in specifcic therapeutic areas. The facility is designed to handle conventional small molecules, Biologics and ADCs (from Conjugation to Fill Finish) and very much focused on innovative compounds. With full containment facility, applying the most advanced and safe technologies, BSP can offer a wide range of services for Pre-Clinical, Clinical and Commercial supply in compliance with the highest Quality requirements. Ensuring supply security for these life-saving product categories is the basis of the strategic partnerships that BSP has established to date.

Type of Drugs Manufactured:

Small Molecule;Biologics

Which CDMO Services do you offer?:

Drug Substance Manufacturing (API);Drug Product Formulation (FDF);Aseptic Fill Finish;Research & Development;Clinical Trials materials and logistics;Analytical Development

No. of Manufacturing Facilities:

1

Please select any High Potent Products capabilities:

OEB 4-5

Facilities Locations:

Europe

Regulatory Approvals for your facilities:

FDA (United States);EMA (Europe);ISO;GMP;PMDA (Japan);NMPA (China);Health Canada;ANVISA (Brazil)

Manufacturing Technologies:

Liquids;Lyophilized amps/vials

Company Products and Services:

CMO/CDMO

Current Capacity:

BSP has had the foresight to anticipate the current need being ready with significant capacity to satisfy the market needs. We have a clear vision on how the company will continue its organic growth in the next 5 years and we are confirming the strategic positioning of our services in selected therapeutic areas. In alignment with our continued investment strategy, we have added substantial fill-and-finish liquid and lyophilization capacities to meet the rising demand for injectable products. We also decided to expand new capacity in novel modalities to sustain the actual demand of manufacturing of new ADCs, as well as non-conventional formulations, like lipid based nano medicines, peptides or polypeptides, proteins and oligonucleotides both in the oncology, immune-oncology and immunotherapy field.
Certification
Brazil ANVISA, Canada Health Canada, United States FDA, Europe EMA, Italy AIFA, Russia Roszdravnadzor, South Korea MFDS, Kenya, Saudi Arabia, ISO 14001

Contact Information

Address
Via Appia Km 65.561, 04100, Latina, Italy
Zip/Post Code
4013
Facility Locations
Italy

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