Cytovance Biologics

Cytovance Biologics Overview

Cytovance Biologics specializes in the production of therapeutic proteins and monoclonal antibodies from mammalian and microbial cell culture. Cytovance provides process creation and development, phase I, II, and III clinical trial materials for therapeutic proteins and monoclonal antibodies. We place significant value on customer service through communication, collaboration and flexibility.

The services we offer include:

API/Bulk Mammalian (up to 1000L scale)
API/Bulk Microbial (up to 100L scale)
Process Development
Analytical method Development
Stability Studies

We offer a full range of biopharmaceutical services from cell line generation, process and analytical development to cGMP manufacturing. We are dedicated to adding significant value by helping companies advance recombinant protein and antibody products rapidly and cost-effectively from the bench through clinical development and to commercial launch.

Cytovance primary mammalian cell culture state-of-the art cGMP facility spanning 44,000 sq. ft. was custom-designed for multi-product cGMP manufacturing and meets US and EU regulatory standards. The facility features primary production in cell culture suites featuring bioreactors at 100L, 500L, and 1,000L (w/v) scale under ISO 7 (previously class 10,000) classification. Additionally a 200L (SUB) is housed in this facility. Recovery and purification take place in adjacent independent ISO 7 suites. The facility also features an ISO 6 classification suite suitable for small scale cGMP liquid fill and finish operations. The facility holds our warehouse which is regulated by our quality assurance department and meets the standard set forth by the FDA. Rapid expansion is possible in an additional ISO 7 primary production suite the facility features expansion space that will accommodate a larger bioreactor train, associated purification suites, and support areas.

The adjacent 26,000 sq. ft. facility houses the development laboratories consists of 15,000 sq. ft. of class A wet lab space and also 6,000 sq ft. cGMP clean room facility whereby cell banking and microbial production operations occur. Six additional clean room suites are available for operating pilot production or custom processes which are available on a customer-dedicated basis if required. Quality control and process development laboratories are located in this facility which also houses our administrative offices.

At Cytovance Biologics we measure our success by the success of our customers meeting their milestones. It is our objective to develop open, collaboration long-term relationships with every customer and to be viewed as a trusted and reliable partner in the development and manufacture of biopharmaceutical products.

Cytovance team is the key to delivering excellent performance and exemplary service. Our highly experienced professionals are drawn from throughout the global biotechnology and pharmaceutical industries and have first-hand experience in the development, cGMP production, validation and launch of recombinant protein and antibody products. This experience allows our team to proactively predict potential problems in a development program and instill mitigation tactics to prevent them from occurring.

Before starting any project, we work hard to foster open and honest communication with our customers and to truly understand their business as well as technical project drivers and deliverables. In this way we are able to carefully plan work programs which are flexible and are able to accommodate change as required.