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Contract Development and Manufacturing Services

Services HBS

  • Aseptic fill-and-finish

    • Formulation and fill-and-finish of sterile drug products:
      • Comprehensive formulation services for sterile drug products
      • Fill-and-finish operations for liquid vials
      • Ensuring compliance with stringent sterility and quality standards throughout the process
    • Manufacturing facilities formulation:
      • Reactors until 1,200L working volume
      • Hi-pressure homogenizers
      • Hi-shear agitators
      • 2,000L single-use mixers
    • Aseptic filling lines: 
      • Isolator technology high-speed (24,000 u/h) filling line with 100% IPC (from 2R to 10R vials)
  • Microbial platform

    • E. coli and yeast protein expression systems including microbial culture, production of peptides, and production of recombinant proteins
    • Production of the GMP Master Cell bank
    • Upstream production:
      • Scale: fermenters and single-use bioreactors ranging from 50L to 2,000L
    • Downstream production:
      • Chromatography equipment
      • Tangential flow filtration systems
      • High-pressure homogenizer
      • Single-use systems for downstream processing
  • Cell culture platform

    • Adherent and suspension cell lines including production of recombinant proteins, monoclonal antibodies, and viral antigens, using mammalian, avian, or insect cell lines
    • Production of the GMP Master Cell bank
    • Upstream development and production:
      • Scale: Single-use bioreactors ranging from 50L to 500L
    • Downstream development and production:
      • Chromatography equipment
      • Tangential flow filtration systems
      • Single-use systems for downstream processing
  • Preclinical development studies

    • Design and performance of detailed protocols for in-vivo studies, ensuring adherence to relevant guidelines and regulatory requirements to ensure robust and reliable study outcomes
    • Development and optimization of appropriate animal models tailored to the specific requirements of the research, facilitating accurate and relevant pre-clinical evaluations
    • Development and validation of analytical methods to assess the immunogenicity and safety of the products
    • Execution of preclinical development studies in accordance with Good Laboratory Practices (GLP), ensuring rigorous adherence to quality standards and regulatory compliance throughout the study process
    • Preparation of final reports summarizing the results and conclusions of the in-vivo studies, providing clear and detailed documentation for regulatory submission and scientific review
  • Analytical methods development

    • Development and validation of analytical methods for both drug substance and drug product to ensure consistent product quality. Our approach  includes establishing methods that guarantee accuracy, precision, and reliability of analytical results, in strict compliance with GMP regulations
    • Smooth transfer of analytical methods ensuring that all methods are properly implemented and validated
    • Broaden analytical capabilities and expertise to assist in all phases of process development through to manufacturing
    • Specialized analytical techniques, such as ELISA, qPCR, peptide mapping, HILIC (hydrophilic interaction liquid chromatography), BLI (Bio-layer Interferometry), sterility and endotoxin testing, SEC-HPLC, and CE-SDS, among others
  • Process development and scale up

    • Process development, validation and industrial scale up, from small-scale and early stages to commercial batch production, covering  both Drug Substance and Drug Product
    • High-throughput small-scale bioreactors to perform DoE process optimization and characterization (e.g., Ambr system), and robust scale-up methodologies
    • Formulation development, including but not limited to adjuvant selection where applicable, and scaling these formulations for industrial production
    • Strategic workflow for process characterization and validation
    • Efficient technology transfer of production methods, both inbound and outbound, to enable seamless transitions and scaling up of production
  • Biologics Cell Line and Strain Development

    • Drug discovery capabilities, including viral and bacterial antigens for vaccine development, recombinant proteins (such as mAbs), peptides, enzymes, and more
    • Cell line and strain development tailored for both cell culture (mammalian, avian, or insect) and microbial (bacterial and yeast)
    • Accelerated cell line development pipeline "from gene to manufacturing scale" for the production of recombinant proteins and monoclonal antibodies
    • Stability studies and final buffer composition development are conducted to assess, ensure, and extend the longevity and reliability of biological products

Step inside our cutting-edge facilities and discover our services firsthand.