Biochemical laboratories

Biochemical laboratories
Product Description

BSP Pharmaceuticals S.p.A. offers a wide range of services which includes biochemical laboratories. It 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, in vivo bio-assay. Contact us for more information.

BSP Pharmaceuticals

  • IT
  • 2015
    On CPHI since
Specifications
  • Selling Points
    Quality Service; Reputation
  • Supplied from
    Italy

BSP Pharmaceuticals

  • IT
  • 2015
    On CPHI since

More Products from BSP Pharmaceuticals (8)

  • Oral capabilities

    Product Oral capabilities

    With the highest level of technology and the most innovative solutions applied to all manufacturing areas, BSP can fulfill
    the most stringent requirements for handling conventional oral dosage forms as well the next generation of anticancer
    and cytotoxic products characterized by complex, non con...
  • ADCs Manufacturing services

    Product ADCs Manufacturing services

    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 proce...
  • Quality control laboratories services

    Product Quality control laboratories services

    BSP Pharmaceuticals S.p.A. offers a wide range of services which includes quality control laboratories services. The facility houses chemical, biochemical and microbiological laboratories for the following typologies of analyses: analytical methods transfer/validation; product release testing and stability...
  • Development services

    Product Development services

    BSP Pharmaceuticals S.p.A. offers a wide range of services which includes development services. It is conveniently situated in the production area of the plant. The specialists have the knowledge and training on the plant equipment and production requirements to reduce the risks of scale up failure. The se...
  • Chemical laboratories quality control services

    Product Chemical laboratories quality control services

    BSP Pharmaceuticals Srl offers a wide range of services which includes chemical laboratories quality control services. It includes analytical methods transfer, ich compliant method validation, in process, product release and stability testing, cleaning methods development and validation, raw materials test...
  • Microbiological laboratories

    Product Microbiological laboratories

    BSP Pharmaceuticals S.p.A. offers a wide range of services which includes microbiological laboratories. 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 an...
  • Clinical and Commercial supply services

    Product Clinical and Commercial supply services

    BSP Pharmaceuticals S.p.A. offers a wide range of services which includes clinical and commercial supply services. It offers a high level of expertise to support the manufacturing of clinical products from phase I to phase III; prepare and complete PPQ manufacturing and support commercial product for world...
  • Sterile suites capabilities

    Product Sterile suites capabilities

    CLINICAL AND COMMERCIAL MANUFACTURING
    A UNIQUE MANUFACTURING SYSTEM SPECIALLY DESIGNED FOR ANTICANCER DRUGS, WITH THE FLEXIBILITY TO MANAGE SMALL MOLECULES AND THE COMPLEXITY OF ADCs

BSP Pharmaceuticals resources (16)

  • Brochure Brochure Corporate

    OUR MISSION STATEMENT
    A VALUABLE AND TRUSTED NEIGHBOR IN THE ONCOLOGY COMMUNITY, OFFERING THE BEST TECHNOLOGY AND PROVEN EXPERIENCE TO INNOVATORS AT THE FOREFRONT OF THE FIGHT AGAINST CANCER.
    THE FIGHT AGAINST CANCER IS OURS TOO
    Every day our experience and technology are put to the service of all those forefront of the fight against cancer with determination and innovation FACED WITH SUCH A TOUGH CHALLENGE, ONLY REAL DEDICATION IS CALLED FOR The contribution of BSP to the research and development of drugs for the treatment of serious pathologies like cancer is the driving force in striving to achieve excellence In the constant evolution of anticancer drug research, the distinctive feature of the market in which BSP operates requires high specialization and continuous updating.
  • Brochure Development Services

    ONE STOP SHOP IN THE SUPPLY CHAIN OF ANTICANCER PRODUCTS
    BSP Pharmaceuticals is a Contract Development and Manufacturing Organization focused on production of anticancer and cytotoxic drugs as small molecules and ADC compounds.
    BSP Pharmaceuticals provides a full range of integrated services aimed to support the entire life cycle of a product.
    From the formulation and process development/optimization, through scale up/scale down studies, we can drive the product to cGMP manufacturing for clinical and commercial needs.
    QC laboratories are equipped to run all analytical testing (chemical and microbiological) on raw materials
  • Video BSP Pharmaceuticals QC Laboratories

    BSP Pharmaceuticals S.p.A. offers a wide range of services which includes quality control laboratories services. 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. It includes. Our chemical laboratories quality control services includes: analytical methods transfer, ich compliant method validation, in process, product release and stability testing, cleaning methods development and validation, raw materials testing. Our microbiological laboratories provides 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 ...
  • Video BSP Pharmaceuticals Development Laboratories

    BSP Pharmaceuticals S.p.A. offers a wide range of services which includes development services. It is conveniently situated in the production area of the plant. The specialists have the knowledge and training on the plant equipment and production requirements to reduce the risks of scale up failure. The service includes preformulation studies, dosage form selection, compatibility studies, cleanability studies, stability, formulations, process optimization and scale up, analytical method development and validation. Contact us for more information.
  • Brochure Sterile Injectable Capabilities

    ONE STOP SHOP IN THE SUPPLY CHAIN OF ANTICANCER PRODUCTSBSP Pharmaceuticals is a Contract Development and Manufacturing Organization focused on production of anticancer and cytotoxic drugs as small molecules and ADC compounds.
    BSP Pharmaceuticals provides a full range of integrated services aimed to support the entire life cycle of a product.
    From the formulation and process development/optimization, through scale up/scale down studies, we can drive the product to cGMP manufacturing for clinical and commercial needs.
    QC laboratories are equipped to run all analytical testing (chemical and microbiological) on raw materials, components, in process controls, release and stability testing.
  • Video BSP Pharmaceuticals Sterile vials filling injectable

    BSP Pharmaceuticals is a Contract Development and Manufacturing Organization focused on production of anticancer and cytotoxic drugs as small molecules and ADC compounds. BSP Pharmaceuticals provides a full range of integrated services aimed to support the entire life cycle of a product. From the formulation and process development/optimization, through scale up/scale down studies, we can drive the product to cGMP manufacturing for clinical and commercial needs. QC laboratories are equipped to run all analytical testing (chemical and microbiological) on raw materials, components, in process controls, release and stability testing. Internal Regulatory Affairs team to manage data collection and document preparation for DMF and CMC to support filing activities.
  • Brochure Oral Dosage Capabilities

    ONE STOP SHOP IN THE SUPPLY CHAIN OF ANTICANCER PRODUCTS
    BSP Pharmaceuticals is a Contract Development and Manufacturing Organization focused on production of anticancer and cytotoxic drugs as small molecules and ADC compounds.
    BSP Pharmaceuticals provides a full range of integrated services aimed to support the entire life cycle of a product.
    From the formulation and process development/optimization, through scale up/scale down studies, we can drive the product to cGMP manufacturing for clinical and commercial needs.
    QC laboratories are equipped to run all analytical testing (chemical and microbiological) on raw materials, components, in process controls, release and stability testing.
  • Brochure BSP Pharmaceuticals Oral dosage department

    BSP Pharmaceuticals is a Contract Development and Manufacturing Organization focused on production of anticancer and cytotoxic drugs as small molecules and ADC compounds. BSP Pharmaceuticals provides a full range of integrated services aimed to support the entire life cycle of a product. From the formulation and process development/optimization, through scale up/scale down studies, we can drive the product to cGMP manufacturing for clinical and commercial needs. QC laboratories are equipped to run all analytical testing (chemical and microbiological) on raw materials, components, in process controls, release and stability testing. Internal Regulatory Affairs team to manage data collection and document preparation for DMF and CMC to support filing activities.
  • Brochure ADCs Capabilities

    ANTIBODY DRUG CONJUGATES (ADCs)
    BSP Pharmaceuticals is specialized to support the manufacturing of ADC products from the Conjugation to the Fill-Finish and offers a full and integrated package of services from development to clinical and commercial supply.
    Development, Scale up/down, Quality control, Manufacturing, Registration
  • Video BSP Pharmaceuticals ADCs Liposome manufacturing

    BSP PHARMACEUTICALS is specialized to support the manufacturing of ADC Drug product 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.
  • Video BSP Pharmaceuticals warehouse

    BSP Pharmaceuticals warehouse
  • Video BSP Pharmaceuticals Technical Area

    BSP Pharmaceuticals Technical Area
  • Video Site overview

    Current Capabilities and ongoing expansions
  • Brochure BSP Pharmaceuticals Sterile vials filling injectable

    BSP Pharmaceuticals is a Contract Development and Manufacturing Organization focused on production of anticancer and cytotoxic drugs as small molecules and ADC compounds. BSP Pharmaceuticals provides a full range of integrated services aimed to support the entire life cycle of a product. From the formulation and process development/optimization, through scale up/scale down studies, we can drive the product to cGMP manufacturing for clinical and commercial needs. QC laboratories are equipped to run all analytical testing (chemical and microbiological) on raw materials, components, in process controls, release and stability testing. Internal Regulatory Affairs team to manage data collection and document preparation for DMF and CMC to support filing activities.
  • Brochure BSP Pharmaceuticals Development Laboratories

    BSP Pharmaceuticals S.p.A. offers a wide range of services which includes development services. It is conveniently situated in the production area of the plant. The specialists have the knowledge and training on the plant equipment and production requirements to reduce the risks of scale up failure. The service includes preformulation studies, dosage form selection, compatibility studies, cleanability studies, stability, formulations, process optimization and scale up, analytical method development and validation. Contact us for more information.
  • Brochure BSP Pharmaceuticals ADCs Liposome manufacturing

    BSP PHARMACEUTICALS is specialized to support the manufacturing of ADC Drug product 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.

Frequently Viewed Together

  • Product Sterile Dosage Filling and Lyophilization

    IDT Biologika GmbH provides a wide range of pharmaceutical services which includes sterile dosage filling in vials and pre-filled syringes. With a facility size of 3,600m2, this integrated pharmaceutical/ biological site houses more than 7 filling lines for the aseptic filling of syringes, vials, ampoules ...
  • Product Biologics

    End-to-end development and manufacturing capabilities across different therapeutic modalities and the entire product lifecycle

    Cutting-edge technology platforms for high yielding cell lines (both mammalian and microbial) and high concentration formulations


    Integrated and flexible drug sub...
  • Product Biological Analysis

    Solvias provides high calibre microbiology, chemistry, toxicology and cell biology services according to GMP, CGMP (FDA), GLP and ISO 17025 standards.Testing for sterile and non-sterile products / Environmental testing / Specialised studies (antibiotics, integrity testing, alternative methods) / Endoxin an...
  • Product Drug-device combinations

    Deep technical expertise spanning device conceptualization, drug-device evaluation, assembly process, cGMP supplies and testing

    Capability to assemble and test multiple pens /autoinjector devices from different device manufacturers, offering great flexibility


    Manufacturing excellence wit...
  • Product Biologic drug substance CDMO services

    From pre-clinical development to commercial supply, Patheon by Thermo Fisher Scientific is an industry leader in the development and manufacture of mammalian cell culture drug substances. Patheon offers biotech and pharmaceutical companies the ability to pursue opportunities around the globe with a fully i...
  • Product Physical Sciences - Preformulation & Solid State Services

    Almac's Physical Sciences groups' comprehensive range of services and expertise will help strengthen the success of your product. Identifying and consistently producing a drug in its optimal physical form is vital to any successful drug development programme. It also avoids the need for bridging toxicologi...
  • Product Chemical Development Solutions

    Chemical Development Solutions of GVK BIO provides a convenient, single-site distribution of infrastructure, thereby delivering a seamless and innovative transition of solutions from lab to pilot plant and bulk manufacturing, with speed and quality.

    We ensure quality in the process during th...
  • Product Pharmaceutical packaging machine for ampoules and vials – as a turnkey s...

    The pharmaceutical packaging machine is designed to pack ampoules of two different sizes into boxes of one, two, five or ten pieces each. Furthermore, vials, some with pipettes, are packed individually into boxes in four different sizes. Separator inserts or inner compartments are used with all formats to ...
  • Product Pharmacokinetics of Therapeutic Proteins

    We are fully compliance with the EMA guideline on Clinical Investigation of the Pharmacokinetics of Therapeutic Proteins and other regulations and guidelines of the FDA. Our experience covers a wide range of different kind of large molecules: • Hormones • Biosimilars: protein...
  • Product GxP Audits and Inspection Readiness

    Our auditors have real world experience supporting regulatory inspections and preparing companies for pre-approval inspections. Our team of specialists includes former regulatory agency inspectors and qualified auditors who are proficient in conducting mock inspections, internal audits, vendor and s...
  • Product Cell-based Neutralization Assays

    Experienced cell-based neutralizing antibody assay capabilities. Our experts, at our GLP/GCP compliant laboratory, evaluate each therapeutic, conduct tailored assay development and ensure that each assay is optimized to suitably determine the presence of NAb with maximum possible level of drug toleran...
  • Product Biosimilars Testing Services

    Testing services for biosimilars: Our biosimilar analytical comparability programs provide highly relevant data for early stage characterisation and later stage comparison. These programs evaluate and compare all pertinent features of the biosimilar product and are based on the ICH Q6B. Programs encompa...
  • Product Human Biological Samples Sourcing Service

    CliniSciences offers a sourcing service for fresh, frozen or fixed biological products of human origin from healthy or patients with a disease.

    A- Blood derived products         i- whole blood, plasma, serum, Leukopak      
       ii- cryo...
  • Product R-GIN (L-ARGININE 500 MG)

    R-GIN (L-ARGININE 500 MG)EXPERT FERTILITY  SUPPLEMENTSUPPORT HEALTHY BLOOD FLOW
  • Product Development services

    BSP Pharmaceuticals S.p.A. offers a wide range of services which includes development services. It is conveniently situated in the production area of the plant. The specialists have the knowledge and training on the plant equipment and production requirements to reduce the risks of scale up failure. The se...
  • Product Ex Vivo Solid Tumor Model: The Oncogramme®, a new functional test in onc...

    The Oncogramme® is a standardized functional assay that enables the quantitative evaluation of the anti-cancer capacities of a therapeutic molecule or combination of molecules, directly on cancer primary cells extracted from a patient's tumor.

    As the results of this in vitro evaluation are more ...
  • Product Clinical and Commercial supply services

    BSP Pharmaceuticals S.p.A. offers a wide range of services which includes clinical and commercial supply services. It offers a high level of expertise to support the manufacturing of clinical products from phase I to phase III; prepare and complete PPQ manufacturing and support commercial product for world...
  • Product Hooded HEPA

    Hooded Housing with HEPA
  • Product Microbiological laboratories

    BSP Pharmaceuticals S.p.A. offers a wide range of services which includes microbiological laboratories. 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 an...
  • Product Analytical Services

    With 55+ years of experience, our expert teams develop 1,000+ analytical methods and validate 250+ methods annually. Drawing upon an extensive range of analytical technology, combined with a wealth of analytical knowledge, we can add real value to your drug development and commercialisation programs....
  • Product MODDE® | Explore. Improve. Advance!

    MODDE®  offers Design of Experiments Software that Accelerates Progress.  
    Design of Experiments (DOE) is the fastest and most cost-efficient way to design effective experiments, increase productivity, and tackle your toughest challenges in development and manufacturing. With MODDE®&n...
  • Product Sterile suites capabilities

    CLINICAL AND COMMERCIAL MANUFACTURING
    A UNIQUE MANUFACTURING SYSTEM SPECIALLY DESIGNED FOR ANTICANCER DRUGS, WITH THE FLEXIBILITY TO MANAGE SMALL MOLECULES AND THE COMPLEXITY OF ADCs
  • Product Chemical laboratories quality control services

    BSP Pharmaceuticals Srl offers a wide range of services which includes chemical laboratories quality control services. It includes analytical methods transfer, ich compliant method validation, in process, product release and stability testing, cleaning methods development and validation, raw materials test...
  • Product Serialization & Aggregation Worlwide

    CIT can manage (and authorized) all the different Track & Trace metrics


    EU
    US FDA
    RUSSIA
    CHINA
    KR
  • Product FLUOLEAD

    Innovative nucleophilic fluorination agentBest alternative to DAST, Deoxo-fluor,... Ketone (non-enol form) and carboxylic acid can be fluorinated HIgh thermal stability Easy to handle (solid product) Only 1 step needed for deoxo-fluorination
  • Product Research & Development

    Discovery - Biology, Lead Optimization, Libraries, Synthetic & Medicinal ChemistryDevelopment - Chemical Process R&D, Fermentation, Formulation Development, High Potency, Kilo Lab & Small Scale Manufacturing, Lipid Nanoparticle, Method Development/Material Science, Rare/Orphan, Separation Scien...
  • Product POLEPHARMA BIOTESTING DAYS - EVENT

    4th & 5th of February 2020
    In CCI Portes de Normandie, Evreux (France)
    The event will bring together 200 decision-makers and stakeholders of biotherapies’ development and production. It will last two days during which will be presented conferences, round tables, experien...
  • Product TRIS(Pharma grade)

    CAS NO.:77-86-1Product Code:S0002
  • Product Outsourcing

    Patheon by Thermo Fisher Scientific has a broad manufacturing platform for pharmaceutical and biologic products which provides sustainable solutions for mammalian cell-based and microbial-based manufacturing, green chemistry R&D and manufacturing technologies, and finished dosage production of biopharm...
  • Product PharmaLex

    PharmaLex is one of the largest providers of Development Consulting, Regulatory Affairs, Quality Management & Compliance and Pharmacovigilance worldwide. Our global teams of experts can take you through early strategic planning activities and nonclinical requirements to clinical deve...
  • Product Development Sciences

    Our development laboratories are well equipped for conducting a diverse range of experiments. These encompass formulation development, cycle design and process refinement, as well as evaluating finished product. Ease of scale-up is accomplished by completing process development studies within a pilot scale...
  • Product Enzyme development

    We develop enzymes for a variety of industries using a proven platform to access unique enzymes from biodiversity. Sequence- and function-driven approaches are ready to support the creation of novel panels of biocatalysts with focus on a single asset with FTO or a strong patent position.

  • Product Clinical Trial Services: Business Planning

    Business Planning 
    Collaborate and build strategic plansConduct gap analysisEvaluate risks and benefitsConduct market and competitive landscape analysis
  • Product Peptide and Protein Technology

    Almac’s peptide and protein technology offering is a key component within our suite of services.  We offer a complete range of peptide and protein services from catalogue products through to GMP manufacture from early phase to commercial launch.  We have a proven track record in high quality supp...
  • Product 2-8°C Clinical Trials, Biologics, Vaccines

    Cold Chain expertise.
    CIT can pack any farmaceutical form at 2-8°C
    Vials, ampoules, bags,...


    Ask for our developed service of 2-8°C monitoring via blockchain
  • Product Pao aerosol generator

    M k teknology 1 pvt. Ltd Offers a wide range of products which includes laskin nozzle aerosol generator. Features: It is used to produce poly disperse liquid aerosols which are reproducible in particle size distribution and aerosol mass concentration. Meets all known specifications for filter testing. Cont...
  • Product Biopharmaceutical Secondary Packaging

    Any pharmaceutcal form

    Commercal & Clinical Supply
  • Product UNITYqa

    Our Software System is designed for performing Quality Assurance in case processing. This comprehensive system offers robust features to effectively manage and monitor error handling for both Periodic and Ad-hoc Quality Assurance processes.
  • Product Medical Device Testing

    R&D Analytical SupportIntertek’s significant expertise in bioanalysis and clinical pharmacokinetic studies allows us to support medical device companies working in the areas of preclinical and clinical drug development. Our support services include assay development for API’s, impurities, trace metals ...
  • Product Enzyme screening & proof-of-concept studies

    We offer tailor made screenings of internal and external enzyme panels to identify applicable off-the-shelf biocatalysts for your target reaction. We integrate analytical services such as method development and validation throughout the process to get a reliable statement about the feasibility of your ...
  • Product Gene Synthesis

    • Gene Synthesis • Mutagenesis • PCR cloning • Plasmid Preparation • OEM Service



    Get 4µg of 100% guaranteed gene sequence in 7 days!
  • Product Pharmaceutical packaging in compliance with high pharmaceutical safety s...

    The main task was to integrate the different packaging formats and pack sizes of the sensitive pharmaceutical products on a compact, easy-to-operate packaging line – without losing sight of the high safety requirements typical for the pharmaceutical industry. Both 50- and 100-millilitre vials had to be pac...
  • Product Quality control laboratories services

    BSP Pharmaceuticals S.p.A. offers a wide range of services which includes quality control laboratories services. The facility houses chemical, biochemical and microbiological laboratories for the following typologies of analyses: analytical methods transfer/validation; product release testing and stability...
  • Product ADCs Manufacturing services

    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 proce...
  • Product GMP Therapeutic Expert CDMO

    Plasmid DNA
    Proteins
    mRNAs
    Oligos
    Peptides

    Multimodal and flexible therapeutic manufacturing since 1985.

    FDA inspected company.
  • Product Development of chemo-enzymatic processes

    Inspired by solutions found in biological systems, we are proficient in developing robust chemo-enzymatic processes to produce your target compound. A strong platform on biocatalytic transformations and the ability to develop novel bio-inspired synthesis strategies for your product are our unique selli...
  • Product BioScoutr

    BioScoutr is an innovative end-to-end lead generation service tailored specifically for Contract Development and Manufacturing Organizations (CDMOs), Contract Research Organizations (CROs), and Life Science service providers. This specialized platform aims to bridge the gap between these service providers ...