Product/Service

Biologics: From Molecule To Market

Source: SGS Life Sciences Services
Developing a biologic therapy for market takes a special kind of expertise. SGS Life Science Services works with its clients to meet their specific needs in this complex field.

Developing a biologic therapy for market takes a special kind of expertise. SGS Life Science Services works with its clients to meet their specific needs in this complex field. With 35 years of experience as a global contract service organization, SGS provides integrated biologic solutions from preclinical activities to phase I-IV trials, bioanalytical and quality control testing.

Offering one on one consulting and a tailored package of services, stand alone or full program, SGS enables Biotech companies to efficiently and successfully achieve the objectives of their biologic development programs from Molecule to Market through its R&D center of Excellence for Biologicals, including:

  • Preclinical and Bioanalytical Services
  • Clinical Research Services, Phase I-IV
  • Biopharmaceutical Characterization and Quality Control Testing

R&D Center of Excellence for Biologicals
SGS has invested in and developed a Europe R&D Center of Excellence for Biologics and Vaccines, gathering its scientific expertise to offer preclinical and clinical solutions.

The analysis of biopharmaceuticals such as recombinant proteins and peptides, (monoclonal) antibodies, or nucleic acid-based drugs, requires a different skill set than those of small chemical entities. Due to the absence of well-described compendial methods, new methods need to be developed/validated and usually required new state of art equipment. Many of the analytical techniques such as LC/MS/MS, capillary electrophoresis, qPCR, flow cytometry, ELISA have emerged from an R&D type setting into routine quality control operation.

Team up with SGS for your biological and vaccine development

  • Full integrated specialized services from molecule to market including:
    • Lead qualification and optimization
    • Preclinical and clinical screening
    • Regulatory intelligence and Quality Control along the drug development process
  • Global thinking for local customized services thanks to our global laboratory network.
  • Strong geographic market driven approach to duplicate locally successful developments.
  • Partner with recognized First Class Biotech specialists.

Preclinical and Bioanalytical Services
SGS has the expertise and capacity to both develop assays from scratch (including immunoassays) and to support large scale routine sample analyses, from pre-clinical and clinical studies

  • Largest European CRO in Bioanalysis featuring mass spectrometry and immunoassays.
  • Two GLP bioanalytical laboratories in France and Belgium.

Services:

  • Biomarker and Immunoanalysis Development & Testing
  • Bioanalytical Services
  • Preclinical Biopharmaceutical Characterization

Clinical Research Services, Phase I-IV
SGS is one of Europe's largest First-In-Human pharmacology centers and Bioanalytical service providers. SGS has the expertise to develop and the capacity to deliver on time complex trials supporting screening or large scale trials and analysis, from pre-clinical and clinical studies.

  • Phase I-IIa Clinical Trials
    • First-in-Human
    • ADME 14C
    • Exploratory Trials
  • Phase II-IV Clinical Trials
  • Data Management and Biostatistics
  • Regulatory and Medical Affairs

Team up with SGS for your complete Clinical Development

  • Leading European company in Exploratory and Pharmacology trials including First-in-Human, combined protocols, QT/QTc prolongation, C14 ADME, AMS, PET and POC in-patients trials
  • Global expert in Clinical Trial Management focusing on Infectious Diseases
  • Strong Biometrics group; pioneer in use of EDC systems for phase I to IV, CDISC compliant
  • Full support Regulatory Affairs and Pharmacovigilance services

Facilities

  • Two FDA inspected Clinical Pharmacology Units in Europe (Paris/Antwerp) - 172 beds
  • Global Clinical Trial Monitoring and Management
    • Seven offices covering Europe (incl. CEE) and North America

Biopharmaceutical Characterization and Quality Control Testing:

  • Development, optimization, transfer and validation of methods
  • Biologics Safety Testing (Mycoplasma, Endotoxin, and Viruses)
  • Host Cell Impurity Testing (Host cell proteins, residual DNA, culture derived impurities)
  • Protein Analysis (characterisation, post-translational modifications, aggregation)
  • Glycosylation and Antibody Testing
  • Molecular biology tests (Species-specific virus detection, gene copy number)
  • Cell Line Characterization
  • Cell-Based Assays (Potency assay)
  • Stability Studies (ICH Q5C)
  • Microbiology
  • Extractables and Leachables
  • Raw Material Testing

Global Laboratory Network
With harmonized global network of 13 laboratories in USA, Canada, Germany, France, Belgium, India, Thailand, Singapore, Taiwan, and China, the analytical development and quality control Services Team provides regulatory compliant (GLP, GMP and/or ISO) analytical services to clients. In addition, two GLP/GCP bioanalytical centers in Europe featuring mass spectrometry and immunoassays complement our quality control network. All laboratories have been inspected by local regulatory authorities and where applicable, the US-FDA. One global Quality Manual, harmonized SOP's and process flow, global QA, and a standardized LIMS system ensure consistent high quality services across all laboratories.

  • Team up with SGS for your R&D and Quality Control Testing
  • Global harmonized network of analytical labs and consultancy in major markets
  • An organization with quality control testing as its core competence
  • Comprehensive breadth and depth of tests performed in one source
  • Analyses performed under cGMP, GLP, GCP, ISO 17025, and ISO 9001
  • FDA registered laboratories
  • Responsive customer service
  • Experienced staff