Cell Line Development

Optimizing DNA sequences in working cell lines

Mammalian cell line development is at the center of everything we do as a CDMO. Optimizing how we deploy a client’s DNA sequence into a working cell line will have more impact on product quality and process productivity than anything that follows. Doing so quickly keeps client programs on track for success.

Bionova’s Cell Line Development work typically focuses on three objectives:

  1. Rapidly develop robust, high-productivity cell lines for manufacturing
  2. Solving difficult customer challenges and bottlenecks related to expression, productivity and product quality
  3. Remain vigilant to lurking issues that could upset a program down the road

Building Better Cell Lines

Our cell line development team screens thousands of potential mammalian cell lines to find the outliers that are most productive and generate the highest quality protein. Bionova routinely helps clients achieve titers that meet or exceed their expectations, up to 10 g/L.

Cell line development scientist at lab hood

Typical Cell Line Development Projects

  • Develop a research cell bank (CHO or HEK 293) or clonally stable high-productivity CHO master cell bank (MCB) for GMP production.
  • Assess and overcome a problem: Clients often come to us challenges including product quality issues, suspected mutations or splicing issues that result in incorrect proteins and post-translational modifications that impact protein performance.
  • Generate first-time research material (from transient or stable pools) to support client discovery work.
  • Produce research material to provide a headstart on upstream, downstream, formulation and analytical development work.

Racing to Human Trials

Our clients are under great pressure to be first-in-human for their chosen targets.  While they race the clock with their competitors, we develop parallel path processes, seek to identify and address problems early, and work collaboratively across our entire upstream, downstream, analytical and formulation teams to cut time to market while ensuring the highest quality product.

The Hard Stuff Makes us Better at the Routine

Our team gravitates towards challenging products:  multi-chain bispecific proteins, non-mAb proteins, and difficult to express proteins (such as enzymes and FC fusion proteins).  For instance, “knob-in-hole” bispecifics are notoriously difficult to produce with high expression and high quality, yet Bionova has helped our clients achieve several knob-in-hole successes.

Cell line development instrument

Starting with the Finish Line in Mind

Regulatory agencies require extensive data during clinical trials.  We know what is needed and carefully generate data and documentation that will be critical down the line.

Go-To Cell Line Development Specialists

Bionova is proud of our cell line development team’s deep expertise and experience in industry and academia.  With knowledge of multiple host cell protein platforms and expertise in optimization of expression plasmids and selection strategies, it is no surprise that our team has been involved in multiple IND and BLA filings.  We are proud of the reputation we’ve earned as a “go-to” cell line development team for critical path cell line development programs.

Fee Friendly Cell Lines

Unlike other CDMOs, Bionova does not impose our own licensing fees or place restrictions on how clients use the cell lines we develop. In fact, we have a research license for the CHOZN® cell line that covers the work we do for clients.  (Production licensing fees must be negotiated with the cell line owner.)

Bionova would love to hear from you.