Accelerated mAb Development Program – From Transfection to GMP Drug Substance in 9 Months

Our Experience Translates to Your Success

Today’s biotech landscape is highly competitive with an unprecedented number of opportunities to address patient needs. Accelerating progress from cell line development to the production of GMP drug substance for Phase 1 and Phase 2 clinical trials is essential for success. At the same time, the need to align activities with funding milestones or adhere to a stepwise investment strategy imposes cost constraints.

Reduce Development Timelines

The Accelerated mAb Development Program shortens development timelines for IgG1 and IgG4 monoclonal antibodies to nine months using an established process that is phase-appropriate and cost-effective, reducing the cost of small-scale downstream operations by 50%. The program embodies our 35+ years of experience in mAb development and process knowledge, continuous innovation, highest quality standards and risk mitigation, along with deep expertise in CMC and regulatory requirements.

With the Accelerated mAb Development Program, biotech companies of all sizes can reduce the time and cost to clinic with confidence. Importantly the process is scalable, designed to establish the foundation for success all the way through Phase 2, and meets regulatory requirements for IND filing.

Efficiencies Across the Entire Process

The Accelerated mAb Development Program reflects our deep process parameter and analytical methods knowledge and expertise. As such, we can shorten the time to clinic through efficiencies across the integrated workflow including:

• Robust cell line for GMP manufacturing
• Early master cell bank generation
• Established process leveraging optimized media and feeds
• Phase-appropriate, off-the-shelf analytical panel for IgG1 and IgG4
• GMP drug substance batch in 200L or 2,000L scale
• IND/IMPD-supporting documentation
• Dedicated project manager, technical lead, and CMC expert

Cost Efficiency via Simplified Downstream Purification

A central driver of cost efficiency is the use of established unit operations across upstream and downstream steps to deliver the necessary requirements for projects moving through Phase 1 and 2 development. Using this approach, we can move rapidly to generate the pilot batch without further process modification. Use of a proven downstream process reduces process development staff time and materials, resulting in a 50% reduction in the cost of small-scale downstream operations.

Within the process itself, we are able to achieve significant cost reductions. As an example, we use mixed-mode chromatography to replace the typical two-step polishing of cation and anion exchange chromatography. Anionic mixed-mode chromatography combines anion exchange and hydrophobic interaction to remove all impurities including host cell proteins, DNA, and aggregates in a more efficient manner with equivalent quality. Minimizing the number of chromatography steps reduces material needs, resulting in a 5% COGS reduction on purification.

Innovation Drives a Faster Timeline

• From transfection to RCB in 3 months
• High-producing cell line
• Accelerated 1-step formulation
• Direct, efficient scale-up from 3L to 2,000L

A Rapid, More Cost-Effective Path to the Clinic

We designed the Accelerated mAb Development Program to be fast, cost-effective, and appropriate for the early clinical phase of your program, with regulatory support throughout.

 Less Risk, Greater Confidence

• Early analytical methods feasibility check based on pool material
• Selection of stable clone based on prediction from early stability results
• De-risking of 200L and 2000L scales with a small-scale process evaluation after cell line development
• Reduce your early-phase investments for phase-appropriate progress against your milestones

As an added benefit critical to accelerating your process, the purpose-built Accelerated mAb Development Program uses a set of standard materials to minimize the possibility of delays and disruptions. As a result, your timelines are insulated from supply issues.

Put your Antibody on the Express Lane

Ready to accelerate your timelines? Consider our Accelerated mAb Development Program. We’ve integrated upstream and downstream unit operations and made them more streamlined and efficient. We’ve surrounded the phase-appropriate, cost-effective process with robust analytical methods and a team of experts in regulatory, CMC, and quality assurance to position your process for long-term success.

✓ 35+ years of process parameter and analytical knowledge
✓ 10+ years of experience using single-use equipment
✓ 85+ GMP batches released in the last 10 years
✓ 60+ mAb projects brought to GMP
✓ CMC regulatory excellence demonstrated across 130 projects

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