Abbvie Biologics' Drug Product Development

 

Abbvie Biologics' Drug Product Development

Abbvie Biologics' drug development and manufacturing services leverage its proven expertise to provide biologics, biosimilars, and vaccines. Abbvie has extensive experience with drug fill finish process development for all its phases. Our scientists have experience in different sort of formulations and merchandise presentations for your drug product formulation.

Whether your molecule needs vials (liquid or lyophilized) or syringes, Abbvie's high-speed filling lines offer the absolute best degree of aseptic processing. They are integrated with secondary packaging to supply your clinical or commercial product to patients reliably.

Process Development

From cell culture through recovery and purification, our scientists develop processes that ensure consistent CGMP manufacturing performance and a reliable product supply. The use of identical bioreactors helps a smooth transition from non-GMP to GMP manufacturing. Comprehensive, integrated analytical testing ensures product quality attributes throughout the tactic.

Upstream Development

An optimum process is developed during upstream development to maximize product titer with the correct Quality Target Product Profile (QTPP). Media and feed strategies and other process parameters get assessed using DoE methods. Once established at a small scale, the process progresses to preparation for GMP manufacturing.

Downstream Development

Purification development has three chromatography steps and multiple filtration steps to purify and concentrate the merchandise. Once the process is optimized, large-scale production and engineering runs confirm process performance at a larger scale. The purified bulk drug substance is entirely verified to meet specification anticipated for GMP material.

Abbvie Biologics has extensive experience in biosimilar development and manufacturing, with multiple biosimilar products on the market utilizing our technology. We offer customizable solutions from cell line development to finished product supply. Our portfolio of developed cell lines can help accelerate your biosimilar development across multiple therapeutic areas.

Drug Substance 

Abbvie Biologics' drug biomanufacturing services provide scalability to support your growth. We have integrated process development and analytical services to unravel your most challenging development and biologics manufacturing challenges. Abbvie's state-of-the-art facilities utilize either single-use or stainless-steel bioreactors during a rigorous CGMP environment.

Advantages of Biomanufacturing

Whether you're using an Abbvie technology-based cell line or your cell line, we'll have a production process capable of producing your biologic under a rigorous CGMP environment.

The development and biomanufacturing teams work closely together to ensure scalability to full cGMP production.

●Analytical laboratories support method development and stability testing.

●Abbvie quality system – inspection performance better than the industry average 

●Proven experience working with the right sort of molecules, including antibodies, fusion proteins, biosimilars, antibody fragments, and other complex recombinant proteins 

●Flexibility to support small, clinical, and commercial-stage programs 

●Ability to tech transfer later-stage projects.

●Expertise in biosimilar development, bioanalytics, medicine fill-finish, and drug substance biomanufacturing 

Pharmaceutical Fill Finish

Abbvie Contract Manufacturing has extensive experience with drug product process development for phase I clinical trial and II early- to mid-stage, including the following:

• Freeze-thaw study at scale or with scale down model

• Mixing study at scale or with scale down model

• Pumping study (peristaltic or time pressure pump)

• Vmax and filtration study with scale down model

• Lyophilization cycle development