Integrated biologics and vaccine development

Integrated biologics and vaccine development
Product Description

E BioSol provides integrated development support for biologics and vaccines, helping clients advance programs from early development through clinical supply, technology transfer and commercial manufacturing.

Our services include:

  • Developability and technical feasibility assessments
  • Cell-line and microbial-strain development support
  • Upstream and downstream process development
  • Process optimization, scale-up and characterization
  • Formulation and drug-product development
  • Analytical method development, qualification and validation
  • Stability studies and product characterization
  • Clinical-supply manufacturing
  • Technology transfer and process validation
  • Regulatory and CMC documentation support
  • Commercial manufacturing readiness
  • Integrated program management across development, drug substance and drug product
  • Our multidisciplinary teams bring together process development, ana...

    BIOLOGICAL E. LTD

    • Country/Region:
      India
    • On CPHI since:
      2015
    • Employees:
      5000+
    Company types
    Manufacturer/Innovator
    Specifications
    • Details
      E BioSol provides integrated development support for biologics and vaccines, helping clients advance programs from early development through clinical supply, technology transfer and commercial manufacturing.

      Our services include:

    • Developability and technical feasibility assessments
    • Cell-line and microbial-strain development support
    • Upstream and downstream process development
    • Process optimization, scale-up and characterization
    • Formulation and drug-product development
    • Analytical method development, qualification and validation
    • Stability studies and product characterization
    • Clinical-supply manufacturing
    • Technology transfer and process validation
    • Regulatory and CMC documentation support
    • Commercial manufacturing readiness
    • Integrated program management across development, drug substance and drug product
    • Our multidisciplinary teams bring together process development, ana...
  • Supplied from
    India
  • BIOLOGICAL E. LTD

    • Country/Region:
      India
    • On CPHI since:
      2015
    • Employees:
      5000+
    Company types
    Manufacturer/Innovator

    More Products from BIOLOGICAL E. LTD (21)

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      Product Cartridge Filling

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    • Cell-line, upstream and downstream process development

      Product Cell-line, upstream and downstream process development

      BE BioSol provides integrated process-development support for biologics, vaccines and recombinant proteins. Our capabilities include cell-line and clone selection, media and feed optimization, fermentation and cell-culture process development, and scale-up. Downstream services include harvest clarification...
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      Product Clinical and Commercial Sterile Manufacturing

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    • Clinical-Supply Manufacturing

      Product Clinical-Supply Manufacturing

      BE BioSol provides flexible clinical-supply manufacturing for biologics, vaccines and sterile injectable products, supporting programs from early-phase development through pivotal clinical studies. Our teams work closely with clients to establish practical, phase-appropriate manufacturing strategies that b...
    • Commercial Technology Transfer and Lifecycle Management

      Product Commercial Technology Transfer and Lifecycle Management

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    • Formulation and drug-product development

      Product Formulation and drug-product development

      BE BioSol provides formulation and drug-product development services designed to improve product stability, manufacturability and delivery. Capabilities include buffer and excipient screening, pH and concentration optimization, stability and stress studies, container-closure compatibility, and lyophilizati...
    • Integrated Development-to-Commercial Supply

      Product Integrated Development-to-Commercial Supply

      BE BioSol provides an integrated pathway that supports biologics, vaccines and sterile injectable products from early development through clinical manufacturing and dependable commercial supply. By bringing scientific, technical, regulatory and manufacturing expertise together within one organization, we h...
    • Lyophilized-Vial Filling and Cycle Development

      Product Lyophilized-Vial Filling and Cycle Development

      BE BioSol provides integrated formulation, lyophilization-cycle development and aseptic vial-filling services for biologics, vaccines and complex injectable products requiring enhanced stability or extended shelf life. Our teams support programs from early development and clinical manufacturing through pro...
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      Product Mammalian Drug-Substance Manufacturing with four 5,000 L Single-Use Bioreactor Trains

      BE BioSol is expanding its mammalian drug-substance manufacturing capabilities with four 5,000 L single-use bioreactor trains, providing up to 20,000 L of total production capacity. The flexible, modular design will support efficient product changeover, parallel manufacturing campaigns and scalable product...
    • Microbial Fermentation from 50 L to 4,000 L

      Product Microbial Fermentation from 50 L to 4,000 L

      BE BioSol offers scalable microbial-fermentation capabilities ranging from 50 L to 4,000 L, supporting the development and manufacture of vaccines, recombinant proteins and other microbial-derived biological products. This flexible capacity enables clients to select the appropriate scale for process develo...
    • Prefilled-Syringe Filling (PFS)

      Product Prefilled-Syringe Filling (PFS)

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    • Process Characterization, Scale-Up and Technology Transfer

      Product Process Characterization, Scale-Up and Technology Transfer

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