Paragon Bioservices
Catalent Biologics is a global leader in biologics development and manufacturing, offering comprehensive solutions from development to finished product supply. With advanced technologies like GPEx®, SMARTag®, and AAV vectors, they help create next-generation therapies. Their integrated approach, OneBio®, accelerates development and supply, emphasizing quality, innovation, and flexibility to support life-changing medications.
Industries
Nr. of Employees
large (251-1000)
Paragon Bioservices
Products
Cell line development platform for mammalian expression
Platform process for rapid generation of stable, high-titer mammalian production cell lines suitable for downstream process development and scalable manufacturing.
Site-specific bioconjugation platform for ADCs
A chemoenzymatic conjugation approach enabling aldehyde-tag-based, site-specific payload attachment with control over payload location and drug-to-antibody ratio to produce homogeneous ADCs.
Platform AAV manufacturing process
A scalable, cGMP-ready AAV platform process designed to accelerate production of clinical material for early-stage gene therapy programs.
Closed GMP-compliant cell therapy manufacturing workflow
Integrated closed manufacturing workflow for autologous cell therapies designed to meet GMP requirements and support clinical manufacturing throughput.
Cell line development platform for mammalian expression
Platform process for rapid generation of stable, high-titer mammalian production cell lines suitable for downstream process development and scalable manufacturing.
Site-specific bioconjugation platform for ADCs
A chemoenzymatic conjugation approach enabling aldehyde-tag-based, site-specific payload attachment with control over payload location and drug-to-antibody ratio to produce homogeneous ADCs.
Platform AAV manufacturing process
A scalable, cGMP-ready AAV platform process designed to accelerate production of clinical material for early-stage gene therapy programs.
Closed GMP-compliant cell therapy manufacturing workflow
Integrated closed manufacturing workflow for autologous cell therapies designed to meet GMP requirements and support clinical manufacturing throughput.
Services
Large-molecule analytical services (GMP and non-GMP)
Comprehensive analytical testing including method development/validation, GMP lot release, characterization, stability testing, biosimilarity and investigational studies for biologics and advanced therapies.
Drug substance development and manufacturing
Cell line development, upstream process development (fed-batch and perfusion), and CGMP manufacturing using single-use or stainless-steel bioreactors to supply clinical and commercial biologics.
Drug product development and manufacturing (fill/finish)
Formulation development, process development, analytical development and fill/finish operations (vial, syringe, cartridge) with integrated device assembly, inspection and packaging at clinical through commercial scale.
Bioconjugate and ADC development services
Site-specific bioconjugation development, linker/payload optimization, analytical characterization and partnering/licensing options to support ADC discovery through clinical stages.
Cell and gene therapy process development and manufacturing
Platform AAV production and closed GMP-compliant workflows for cell therapies to accelerate manufacture of clinical material for gene and cell therapy programs.
Clinical supply and cold-chain logistics
Clinical supply management, comparator sourcing, cold-room secondary packaging, global cold-chain distribution (EPS/VIP/PCM systems), temperature monitoring and import/export regulatory support.
Large-molecule analytical services (GMP and non-GMP)
Comprehensive analytical testing including method development/validation, GMP lot release, characterization, stability testing, biosimilarity and investigational studies for biologics and advanced therapies.
Drug substance development and manufacturing
Cell line development, upstream process development (fed-batch and perfusion), and CGMP manufacturing using single-use or stainless-steel bioreactors to supply clinical and commercial biologics.
Drug product development and manufacturing (fill/finish)
Formulation development, process development, analytical development and fill/finish operations (vial, syringe, cartridge) with integrated device assembly, inspection and packaging at clinical through commercial scale.
Bioconjugate and ADC development services
Site-specific bioconjugation development, linker/payload optimization, analytical characterization and partnering/licensing options to support ADC discovery through clinical stages.
Cell and gene therapy process development and manufacturing
Platform AAV production and closed GMP-compliant workflows for cell therapies to accelerate manufacture of clinical material for gene and cell therapy programs.
Clinical supply and cold-chain logistics
Clinical supply management, comparator sourcing, cold-room secondary packaging, global cold-chain distribution (EPS/VIP/PCM systems), temperature monitoring and import/export regulatory support.
Expertise Areas
- Biologics CDMO services (end-to-end development and manufacturing)
- Large-molecule analytical development and GMP testing
- Formulation development for parenteral biologics
- Drug product process development and QbD
Key Technologies
- Aseptic isolator filling technology
- Automated high-speed vial and syringe filling
- Capillary electrophoresis and CE-SDS
- SEC-UHPLC and ion-exchange HPLC