Services & Capabilities

Manufacturing of Biopharmaceutical Products

• cGMP-compliant Cell Line Development • Upstream & Downstream Process Development • Biologics Production • Analytical Services •

cGMP-Compliant Cell Line Development

Our services include production of cGMP-compliant Research, Master and Working cell bank (RCB, MCB and WCB). Mammalian Chinese Hamster Ovary (CHO) and hybridoma cells adapted to grow in chemically defined media may be used for the cell line development.

Candidate clones are evaluated for stability in shake flasks for at least 50 generations. Following stability studies, a few clones are selected for small-scale (5 L) bioreactor runs. Based on the performance of the clones in these runs, the top clones are used for further cell line development (RCB, MCB). After performing cGMP-compliant tests, MCB are stored and used for production of working cell bank and production of biologics based on your needs.

Cell Line Development Services:

  • Selection

  • Quality Assessment

  • Stability

  • Storage

  • Adapting hybridoma cell lines to grow in chemically-defined, serum-free media

Process Development

Our team has expertise in efficient technology transfer, process research, development and characterization. Our upstream, and downstream development processes are well-standardized and coordinated to ensure that clients receive a top-class process and characterized biologic with consistent quality.

During the process of technology transfer, our highly experienced biologic process development team will incorporate necessary modifications to client-provided SOPs to fit scale-up production of the biologic in consultation with the client in a time sensitive manner. All through the process development up to the final production scale, analytical assays are performed to ensure that the specs for purity and potency of the biologic are met with consistently.

Our experience with both “platform-type” antibodies and more complex non-antibody recombinant protein purification processes including membrane proteins gives us the capability to design, develop, optimize, and troubleshoot downstream processes with a variety of approaches.

Upstream Process Development Services

Cell culture processes from 100 mL up to 40 L bioreactor scale

  • Batch, Fed-Batch, or Perfusion Process Development

  • Media Evaluation/Comparison

  • Media Optimization

  • Seed Train/Inoculum Development

  • Critical Parameter Definition

  • Qualification Support

  • Use of Single Use Technologies (SUT) to provide significant advantages in cost, operational flexibility, and reliability

  • Accommodate small and pilot scale development work including capability for BSL-3 agents

Downstream Process Development Services

  • Cell Lysis Optimization

  • Clarification (depth filtration)

  • Concentration (TFF)

  • Chromatography Method Development

  • Viral Inactivation

  • Viral Filtration

  • Buffer Exchange (TFF)

  • Fill-Finish

Quality Control (QC) In-process Release and Stability Testing, including BSL-3 agents

Biologic Production

Our biologic production team has experience in the production of cGMP-compliant antibodies and membrane proteins. cGMP-compliant biologics are manufactured using SOPs developed based on the data obtained from process development lots. Two membrane proteins manufactured in our facility were approved by FDA for phase 1 human clinical trials.

  • Use of Single-Use Technologies to provide significant advantages in cost, flexibility, and reliability

  • Compliant commercial scale cGMP biologics manufacturing from BSL-1 through BSL-3

  • Scale-Up

  • Buffer exchange and concentration (TFF)

  • Viral inactivation

  • Viral filtration

  • Agile, flexible manufacturing based on single-use equipment

Analytical Services

Our analytical services support the transfer, development, and validation of standard and customized methods necessary to characterize and release pharmaceutical and biologic products. Our team’s experience and flexibility in phase appropriate development ensures timely and efficient drug development.

  • In-Process Testing Methods

  • Characterization Assays

  • Release Assays

  • Assay Transfer and Assessment

  • Product Characterization

  • Process Development Support

Contact Us

If you are interested in learning more about our services or how we can help you, please contact us