Cell Line Development: An Overview of the Linchpin in Successful Biotherapeutic Development

In our whitepaper find out about how cell line development (CLD) is the linchpin of biotherapeutic development and manufacturing.

The U.S. Food and Drug Administration (FDA) approved the first DNA recombinant protein – human insulin (Humulin) – in 1982, setting the precedent for using recombinant technologies to generate therapeutics.

From producing cutting-edge vaccines to cancer-fighting medicines, there has been rapid growth in the use of cell lines to produce a growing number of biologics entering the market targeting a wide variety of therapeutic areas. The blockbuster status of many biologics and advancements in biotechnology have driven the growth of this sector of drug development.

What is CLD?

CLD refers to the process in which living cells are used to manufacture and produce therapeutic biologics or other significant proteins. The CLD process begins with small-scale suspension cultures which then progress to industrial-scale bioreactors during the manufacturing phase. By getting the processes right, the balance of high quality, high yield, and speed needed to successfully bring a biologic to market can be achieved working with and experienced CLD services partner.

Why is CLD so important?

CLD is challenging. Establishing cell lines is a long process, with numerous phases to navigate and de-risk. Meeting the increasing global demand for biotherapeutics is also a significant challenge that needs to be met, and relies on the ability to reproducibly deliver biologics at scale. The success of moving a biologic project from lab – to industrial-scale hinges on cell line expertise.

At Abzena we have seen that Monoclonal Antibodies (mAbs) and their derivatives – including Fabs and Fc fusions – have shown remarkable market growth in the past decade. The use of mAbs as therapeutic agents has become routine for the treatment of many diseases such as asthma, macular degeneration, arthritis, Crohn’s disease, and various types of cancer.

How can Abzena help develop cell lines efficiently and reduce risk?

With over 20 years of expertise and a commitment to quality excellence, we can reduce CLD timelines by >30%. Our proprietary AbZelectPRO™ platform accelerates timelines and de-risks CLD programs. Recently enhanced, AbZelectPRO™ efficiently enables the rapid delivery of high-producing cell lines up to 8g/L for complex biologic or bioconjugate development programs.

Request your copy of our Cell Line Development Whitepaper today and find out how Abzena can help accelerate your program.

Discover AbZelectPRO™: DNA to RCB in 10 weeks

Benefits of AbZelectPRO™ with 2G UNic vector technology:

For more complex biologic and bioconjugate programs, we can deliver increased productivity through our AbZelectPRO™ platform. This combines our existing CHO cell line with ProteoNic’s premium expression vector technology 2G UNic.

• Optimized expression cassettes to maximize productivity from each cell
• Efficient GS selection marker compatible with current AbZelectPRO™ CHO Cell Line
• Proven track record – ProteoNic are moving towards regulatory approvals with multiple programs in the clinic and work with several large pharmaceutical firms.
• Early material from highly productive stable pools for antibodies, bispecifics and fusion proteins
• Higher frequency of high-producing clones offering more shots on goal- up to 8 g/L
• Highly stable clones maintaining productivity beyond 60 generations
• Quicker doubling times with a >30% reduction in cell line development timelines
• Uses single-use bioreactors to lower production costs
• Robust scalable and consistent platform process
• Further process intensification can boost titres to achieve 10g/L at scale
• Enhanced cycle times with faster growth with optimized CHO-K1 host cell line

Request a copy of our AbZelectPRO™ Info Sheet on improving cell line development efficiency by clicking the button below.

AbZelectPRO™ Info Sheet