Cell Line Development Services

35+ Years' Experience

800+ Cell Lines Taken to GMP Manufacture

145+ IND/IMPD Filings Supported

A suite of cell line development (CLD) services with your priorities in mind for any molecular format

CLD requires generating single cell-derived clones that produce high and consistent levels of target therapeutic protein.

Once the lead candidate has been identified and a vector generated for use in the selected host cell, the CLD process begins. The process will be tailored to fit the molecule and program needs.

The vector is transfected in a monoclonal host cell line that will not only be able to deliver high titers and desired product characteristics, but also be transferable to manufacturing. At the end of the CLD process, a lead manufacturing cell line will be selected and a research cell bank generated.

The combination of host cell line, vector and stringency of selection enables us to provide our customers with high producing cell lines suited to fit a commercially relevant process.

Advanced technologies used to enhance yield and shorten timelines

Creating cell lines with future manufacturability, cost of goods and speed in mind is of critical importance in today’s biopharmaceutical development.

In addition, there is a large shift in biologics drug development pipelines to newer and more complicated formats. Those next-generation molecules require appropriate expression technologies to realize their potential.

By working with our expert cell culture teams in our Slough (UK), Visp (CH), Guangzhou (China) and Tuas (SG) sites, you will benefit from our advanced technologies and from our GS Gene Expression System® toolbox: including GS Xceed® and GS piggyBac® to develop a recognized and stable cell line.

Building on more than 35 years' experience, we can support the development and manufacturing of a large variety of molecules ranging from simple monoclonal antibodies to fusion and scaffold proteins.

Our services can be customized to accommodate your priorities in terms of timeline, yield optimization, budget and risk.

Examples of technologies enabling our CLD offering

Transfection: GS piggyBac®

Transposon technology that allows a targeted insertion of the DNA in high-performing regions of the genome. Combining our GS System® with piggyBac™ transposon technology results in increased yields with both pools and clones.

Cloning: Beacon™ Opto-fluidic Technology

Fully enclosed multifluidic platform designed to significantly shorten the cell selection process and bring your molecule into clinical testing faster.

Expansion: GSv™ Platform Process

GSv9 Media and Feeds to unleash the full expression potential of your protein, enhancing product quality.

Achieve a seamless transition from development into cGMP manufacturing

Your cell line will be developed using procedures based on achieving high product titers and the desired product characteristics. Selection experiments carried out in miniature bioreactors with an abridged version of our platform manufacturing process will help to reduce risks at later stages and allow a seamless transition from development into cGMP manufacturing.

Close interactions with regulatory authorities worldwide eases regulatory hurdles, since these cell lines will be constructed, cloned and characterized according to regulatory guidelines. In addition, the use of electronic notebooks enables real-time data entry, reduces human error and offers the full traceability required by regulatory authorities. To date, we have successfully supported over 145 IND/IMPD.

A dedicated cGMP unit within our licensed manufacturing facility is used to create master and working cell banks for subsequent use. The cell banks are characterized in accordance with FDA and European regulatory agency requirements. For safety and security considerations, dual-site storage of all cell banks is maintained between our facilities.

Case studies

Small biotechs who chose to partner with us

Small Biotechs Need: A Committed CDMO

Ensuring Biotherapeutic Success from Phase 1 to BLA

Andrea Cubitt of aTyr Pharma discusses how Lonza is uniquely positioned to support emerging biotech innovators with tailored development strategies specifically designed to keep commercialization at the top of mind.

Small Biotechs Need: A CDMO with Flexible Capacity

Laying the Foundation for Success in Small-Batch Protein Development

Julie Trulson of Asher Biotherapeutics discusses Lonza’s proactiveness in bringing on Asher’s cis-targeted immunotherapy program, the flexibility that the Lonza team displayed in outlining the program’s structure and project plan, and her hopes for Asher and Lonza’s relationship moving forward.

Small Biotechs Need: An Engaged CDMO

Adapting Deal Structures for a Small-Scale Cis-Targeted Immunotherapy Program

Julie Trulson of Asher Biotherapeutics discusses how Lonza was not only willing – but eager – to take on her team’s small-scale biotherapeutic manufacturing program, as well as the flexibility and expertise that went into building a proposal that was the right fit for Asher.

Small Biotechs Need: CDMOs with Adaptable Platforms

Leveraging Expertise to Ensure Efficiency in Immuno-Oncology Manufacturing

Andrea Cubitt of aTyr Pharma highlights the collaborative efforts between her team and the specialists at Lonza in optimizing the Ibex® program to achieve efficient manufacturing timelines and budget for aTyr’s immuno-oncology monoclonal antibody (mAb).

Small Biotechs Need: To Consider Manufacturability

Supporting Emerging mAb Innovators with a World-Class Team

Andrea Cubitt of aTyr Pharma highlights the transformative impact Lonza’s team had on her antibody manufacturing program, emphasizing the critical role of well-optimized processes as a cornerstone of enhancing scalability as programs progress through trials.

Small Biotechs Need: A Transparent CDMO Partner

Expertise and Collaboration Foster Success in Biotherapeutic Manufacturing

Julie Trulson of Asher Biotherapeutics discusses her team’s process in choosing a CDMO for their small-scale immunotherapeutic manufacturing program, the value that Lonza’s technical experts have delivered for them, and the transparent, collaborative partnership built along the way.

Small Biotechs Need: The Right CDMO

Protein development at Levicept

Simon Westbrook had an idea for a complex fusion chimera protein he believed could have a profound impact on chronic pain and joint degeneration in osteoarthritis patients. Lonza worked with him early on and the molecule is now in Phase II.

Small Biotechs Need: The Right CDMO

Surrozen – complex bispecific antibodies targeting tissue regeneration

Surrozen’s President & CEO, Craig Parker, discusses how the expertise, resources and flexibility of Lonza have been fundamental in advancing its novel and complex bispecific antibody candidates that target the WNT pathway.

Small Biotechs Need: The Right CDMO

Tuning the Myeloid Compartment with a Best-in-Class CDMO

Alicia Levey and Kiren Khanduja of Pionyr Immunotherapeutics discuss the basis for selection of Lonza to meet Pionyr’s goals to rapidly develop a third lead candidate from the start and to scale-up manufacturing of two clinical-stage immuno-oncol-5ogy treatments after tech transfer.

Small Biotechs Need: The Right CDMO

Monoclonal antibodies at Corvus

Corvus is a small biotech developing a monoclonal antibody for oncology patients. Lonza started work with available capacity in Singapore and then transferring to Slough, UK. The product is currently in clinical trials.