In Vitro Monoclonal Antibody Production

Services and Offerings

• Harlan Bioproducts for Science, Inc. (HBPS) has the expertise and capacity to provide in vitro antibody production when in vivo production is undesirable or impractical.
  
  We can produce research to cGMP grade antibody to meet a variety of regulatory needs. At HBPS, we perform in vitro monoclonal antibody production in several different cell culture production systems such as tissue culture bags and hollow fiber antibody production bioreactor technology. Our cell culture production systems provide highly concentrated supernatants with very low levels of contaminating proteins and endotoxins. Our highly qualified staff has been producing antibody in hollow fiber production bioreactor systems for over 15 years utilizing both cGLP and cGMP documentation 

Antibody production optimization

• Our staff has the expertise to work with your specific cell line to optimize the production of your antibody. Optimization can include media formulation, methods development, process optimization, and/or validation strategies. Product can be produced without the use of animal derived products if desired. As with all our projects, we can also utilize any optimization procedure you have perfected at your facility.

Perform in vitro monoclonal antibody production with varying capacities, using hybridoma cell lines, CHO cells, 293 expressed proteins and others.

• Depending on your future production requirements, the correct capacity hollow fiber bioreactor system(s) will be identified. Depending on the specifics of your particular cell line, secreted cell product and your requirements, we can produce between 10 mg to 200 grams of antibody in vitro in a 30-day production run.

Your partner in production

• By working together, we can supply a steady stream of antibody to meet your demanding development schedules. Our staff will perform a 30-day evaluation/optimization run utilizing the appropriate documentation for your regulatory needs. During the optimization run, we at HBPS welcome your involvement in the evaluation of the resulting antibody and allow you the opportunity to extend the run to produce additional antibody.

Contact Information

• To receive a Monoclonal Antibody Information Sheet, pricing, or for more information about our capabilities, contact our Customer Services Center at 800-972-4362 or email us at hbps@harlan.com. Our technical staff is also available to assist you in determining the type of production system that best meets your needs.