Biologics Process Development & Optimization - Abzena

Ready to move from cell line development to patient faster whilst minimizing risk, accelerating timelines, and reducing costs? Discover Abzena.

Your partner for seamless upstream and downstream process development, optimization and manufacturing from cell line development (CLD) to patient.

Partnering with Abzena accelerates your biologic therapeutic programs by delivering optimized, scalable, high-quality processes. Our specialized mammalian process development expertise reduces development and manufacturing risks, enhances efficiency, and positions your biologic for successful clinical and commercial outcomes. We navigate the complexities of biologic process development so you can focus on bringing innovative therapies to patients faster.

Advance your biologic with confidence:

  1. Experience with multiple mammalian cell types including CHO, ABZ-CHO K-1, sp2/0, yp2/0, and NSO
  2. Experience beyond mAbs including fabs, ADCs, oligonucleotides, nanoparticles, bispecifics, fusion proteins, vaccines, virus-like particles, enzymes, and bioconjugates
  3. Transfer verification optimization of your process
  4. Design of statistical experiments to optimize media feeds and growth conditions
  5. Scale down fed batch and perfusion production models
  6. Robotic systems from 250ml to manufacturing scale at 2K
  7. High cell density and titer optimization
  8. Bench scale process characterization and validation
  9. Coordination with Analytical Method Development (AMD) to determine quality attributes

Why partner with Abzena?

Access to Genuine Scientific & Technical Experts

We have over 20 years of experience in delivering solutions at each stage of the development lifecycle from early-stage research and discovery, through lead candidate selection, and onward into process development and GMP manufacture.

Unlike most other service providers, we can provide technical and scientific support that truly spans early-stage research through process development and GMP manufacturing under a single organization to better ensure that the TPP can be achieved. Our global scientific teams have extensive experience in overcoming some of the most challenging and complex biologic and bioconjugate programs, making us the perfect partner for novel and disruptive technologies that other biopharmaceutical CDMOs may shy away from.

Proactive Problem Solving to Ensure Downstream Success

Our experienced team is focused on getting it right from the start. We identify and address challenges early in drug design to better ensure downstream clinical and commercial success. We also have expertise in fixing and optimizing drugs in later stage development to rescue them from the drug development graveyard.

Diverse & Interconnected Expertise Under a Single Organization

With capabilities ranging from bioassays to cell line development, bioconjugation and clinical and commercial manufacturing, all under one organization, we can reduce the white space in the development path, which ultimately minimizes risk, reduces costs and accelerates timelines for our customers.

As an integrated service provider, we accelerate timelines through the ease of technical and materials transfer, and improved scheduling. Better workflows and processes can also be attained through improved knowledge transfer between internal multidisciplinary experts and the development of a deep understanding of the drug as it progresses from target to lead selection and process development and manufacture.

Driven by Innovation to Streamline Development

Our team is always seeking new ways to innovate and streamline development for our customers. Our extensive scientific capabilities and proprietary solutions like EpiScreen® 2.0, Composite Proteins™, Composite Human Antibodies™, AbZelectPRO™, ThioBridge™, and LabZient™ are designed to give your program the best chance of clinical and commercial success.

  • EpiScreen® 2.0 — an extensive suite of bioinformatic and primary human cell-based assays for immunogenicity assessment to inform of potential safety and efficacy risks in the clinic.
  • Composite Human Antibody™ — a platform used for designing safer, more effective, humanized antibodies.
  • Composite Proteins™ — a deimmunization technology that designs safer and more effective therapeutic proteins, devoid of human T cell epitopes, to minimize potential immunogenicity in patients without compromising activity.
  • AbZelectPRO™ — high-yielding cell line development (CLD) platform for accelerating the generation of production cell lines for manufacture of antibodies and recombinant proteins.
  • ThioBridge™ — a next-generation conjugation linker technology proven to enhance ADC development by overcoming issues with existing technologies to improve stability, potency, and efficacy.
  • LabZient™ — our analytical platform that combines predictive in-silico evaluation with laboratory methods to de-risk the application of platform analytical procedures and expedites the pathway to IND.

A history of successfully moving medicine forward

20+

years of complex biologics and bioconjugation services experience

2000+

conjugates developed for critical assays, and lead candidate selections with over 400 ADCs produced

50+

bioconjugation programs scaled up to produce multi gram batches

Get in touch with us to leverage our process development expertise and let's move your medicine forward, faster.