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バイオ医薬品のプロセス開発

 
 
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From Cell Line to Process Development


Over 32 years of biomanufacturing experience demonstrated through more than 250 projects including:

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Our goal is to enable our clients to reduce the time required to develop and produce cGMP biomolecules for clinical trials, through:
  • Developing robust and scalable manufacturing processes
  • Using the latest processing platforms and technologies
  • Responsive, experienced scientists and project management

Biopharm Process Development Services include:

  • Cell line development
  • Clone selection
  • Media & feed screening
  • Upstream process development
  • Master cell bank establishment
  • Downstream process development
  • Formulation development
  • Analytical methods development & optimization
  • Analytical process development support
  • Biosimilars comparability analytical programs

Leverage our experience with these cell lines, expression platforms, and development activities

CHO* 
Host
ExpressionMolecule TypeM & F Screening Process DevelopmentProduction Scale
CHOZN® CHOZN® Monoclonal antibody

20L-2000L

S DHFR Recombinant Protein 250L
DHFR Fc-Fusion 250L – 1,250L
GS Monoclonal antibody 250L – 1,250L
Catalent Monoclonal antibody 200L
DUKX DHFR Recombinant Protein
variant purification
250L (perfusion)
DHFR Monoclonal antibody 1,250L
DG44 DHFR Fc-Fusion 250L (perfusion)
Biowa Monoclonal antibody 250L – 1,250L
CHEF 1 Monoclonal antibody
K1/K1-
SV
DHFR Fc-Fusion 3L (perfusion)
GS Monoclonal antibody 20L – 2,000L
M Selexis Monoclonal antibody 20L – 2,000L
Horizon GS Monoclonal antibody 200L – 2,000L


 HostMolecule TypeM & F Screening Process DevelopmentProduction Scale
Hybridoma Monoclonal antibody

150L perfusion

NSO Monoclonal antibody

20L

SP2/0

Monoclonal antibody 200L


Plug & Play Upstream Development Service

Get straight to the point with our proprietary CHOZN® platform

Accelerate Identification of High-producing Cell Lines

Learn from Research BDS Scientist Lucie Grindes, BioReliance® End-to-End Solutions, about our mini-pool approach and how we can begin process development in parallel with cell line development.



Featured Resources
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Guidebook: Break Down Roadblocks to Clinical Success
The key to this success is to make the right decisions at the right time. In this guidebook, our experts share some key considerations to help biopharmaceutical companies successfully advance a molecule from the laboratory to the clinic as quickly as possible without sacrificing product quality, process efficiency, or patient safety.

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Case Study: Accelerate Time from DNA to Material
Learn how our approach to mini pools allows us to deliver high-producing clones in an accelerated timeline, saving up to 3 months. In addition, we are able to begin process development in parallel with cell line development for clients with very challenging timelines.

Read Now


Merck:/Freestyle/DIV-Divisional/Services/biopharm-services/parter-to-speed-thumb.jpgBrochure: Your Partner To Speed From DNA To Market
There are many parameters to consider in biologics development – we are your process development and manufacturing partner. Read our brochure.

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Merck:/Freestyle/DIV-Divisional/Services/biopharm-services/plug-play-thumb.jpgBrochure: Plug & Play Upstream Development Service
A service exactly tailored to small-sized biotechs and start-ups, needing to balance cost and speed to clinic while getting it right the first time.

Download Brochure