Typical Project Features:

  • Biologic Drug Substance Production
  • US FDA / EU Regulatory Compliance
  • Weigh / Dispense and QC Sampling
  • Upstream and Downstream Unit Operations
  • Fixed and Single-Use Equipment
  • Product Filling
  • Process Utility Systems
  • Building Utility Systems
  • HVAC Systems
  • Automated Production
  • Cleanroom Spaces
  • QC Laboratories
  • Locker Rooms and Gowning
  • Warehouse and Cold Storage
  • Waste Treatment Systems
  • Bio-Safety Level 1, 2, and 3
  • Viral Segregation
  • Emergency Back-up / Redundant Systems
  • Flexible, Multi-Product Operations

Biologic Drug Substance Overview:

CE&IC is recognized as a leader in the planning and design of biologic drug substance manufacturing processes and facilities. We’ve had the opportunity of working with our clients on a wide range of projects within this technology area. These projects have ranged from developmental pilot scale operations through large scale commercial production. Some of these projects have involved retrofits within existing facilities and others have involved brand new stand-alone facilities/campuses.

We can assist our clients in delivering their Biologic Drug Substance projects from feasibility studies and concept development through detailed design, construction assistance and commissioning. Our clients’ projects typically include a full range of manufacturing unit operations such as weigh and dispense, solution preparation, cell culture, harvest and purification. These facilities also often include various manufacturing support functions such as QC laboratories, warehouse, locker rooms and gowning, process and plant utilities, airlocks and logistics corridors, CIP systems, equipment cleaning and storage, office and support spaces, etc. CE&IC has been highly effective in working with our clients over the past 35+ years to successfully implement efficient, robust and cost effective manufacturing processes and facilities.

Following is a listing of some typical biologic product categories where CE&IC has previous experience:

  • Mammalian Cell Culture
  • Microbial Fermentation
  • Vaccine Production (Viral/Non-Viral)
  • Antibody Drug Conjugates
  • Advanced Therapy Medicinal Products
  • Immunotherapies, including CAR-T
  • Gene Therapies
  • Radiopharmaceuticals