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Biotechnology Consulting

Biotechnology ConsultingBiotechnology ConsultingBiotechnology Consulting

Biotechnology Consulting

Biotechnology ConsultingBiotechnology ConsultingBiotechnology Consulting

About

With almost a decade of experience in cell and gene therapy, we bring a wide array of skills and experience to each project. We believe in the power of biotechnology to transform lives, and are dedicated to helping clients harness this potential and achieve their goals. Whether you’re looking to optimize your manufacturing processes, navigate regulatory hurdles, or understand market trends, our team is here to guide you every step of the way.

Areas of Expertise

Manufacturing, Science and Technology (MSAT)

  • Support/management of process improvement, technology transfer, and process troubleshooting.  
  • Batch Production Record, Development Protocol, and Standard Operating Procedure (SOP) development/revision. 
  • Process validation projects, including Aseptic Process Simulation, Process Performance Qualification, and Electronic system validation (Electronic Batch Record, spreadsheet, etc.)

Process Development

  • Identification of manufacturing process gaps.
  • Implementation of process scale-up and compliance updates.
  • Implementation of process automation. 

Electronic Systems

  • Custom database development and implementation.
  • Identification/development of software solutions to streamline workflows.
  • Data management and analysis.

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