It is expected that within four to five years, biologics will comprise over half of the 100 top selling drugs on the market. However, the high cost and complexity of biotherapeutic development, as well as a dynamic regulatory landscape, still poses challenges to drug developers.
As more therapies enter development, testing and regulatory approval, there is an increased need for process support to ensure compliance and prevent manufacturing complications.
Download this guide to explore five key tips on navigating your biotherapeutic journey including:
- Modular, scalable, end-to-end workflows for mAbs, vaccines, cell and gene therapy development
- Comprehensive regulatory guidance and process development training opportunities
- How to leverage existing equipment in preparation for industrial-scale manufacturing
This is a two time increase from 10 years ago1. Estimations show that in four to five years biologics will comprise over half of the 100 top selling drugs, and over a third of the total biotherapeutics market2. Though monoclonal antibodies are expected to continue dominating the market, a more diversified pipeline that includes DNA and RNA molecules and cell and gene therapies is anticipated as growth continues. As more therapies are discovered, there is increased need for spin-out businesses focused on the development, clinical testing, regulatory approval and manufacturing of these new biologics. Choosing key collaborators to partner with can help overcome some of the challenges explored here. Let us walk you through our translational research solutions and core capabilities. 1. Evaluate Pharma (June 2019) 2. Global Data (2020) 26 out of 7 approved CAR-T cell therapies include Cytiva solutions Did you know? The majority of mAbs approved by the FDA in 2020 and approved mRNA vaccines and gene therapies use Cytiva technologies during manufacture. Our collaborations pioneered the first approved CAR-T therapies. We brought founding academics, pharmaceutical partners, and our own scientists together to efficiently bring this groundbreaking therapy to market. Our translational research team collaborates with your team to recommend appropriate products and services to progress your therapy to clinic. Hear the full story from Dr. Carl June and his team. 3Tip 1 End to end workflows for mAbs, vaccines, cell and gene therapies Modular, scalable, end-to-end complete workflows for every stage of your research. Whatever your therapy type — we have the appropriate products and services. Services and support Sample prep and filtration, reagents, stock solutions and buffers Isolation and sequencing Cell culture Purification Analysis Process development and manufacturing workflow continues on the next page Research and drug discovery workflow We provide instrumentation, assays, and tools for protein and cellular research to catalyze biotherapeutic discovery and development. For over two centuries, from basic research to drug manufacturing, Cytiva products have not only been the first of their kind, but are also at the forefront of research resulting in faster and more impactful outcomes. ÄKTA™ protein purification systems have set the benchmark in chromatography with over 30 000 in use today by researchers across the world to purify proteins. 4Process development and manufacturing workflow We support clients with start-to-finish solutions for production of biotherapeutics such as antibodies and vaccines. This includes process development services and offerings of cell media and single-use equipment for biopharmaceutical production. Research and drug discovery Drug delivery Cell culture seed train and production Clarification and bioburden filtration Sterile filtration and bulk fill Drug product fill Capture Polishing Virus filtration Formulation Virus inactivation Fluid management 5Tip 2 Industry leading thought leadership network and innovation Here we explore examples of collaboration and innovation with our customer and extended industry network. The Centre for Commercialization of Regenerative Medicine (CCRM) is a leader in developing and commercializing regenerative medicine technologies, and cell and gene therapies. Through our work with CCRM we provide CBMG with process development services. Our combined process development team includes 35 scientists and engineers with expertise in advanced therapeutic cell technologies. This diverse team helps bridge the gap between research protocols and industrial manufacturing. Cytiva and CCRM support CBMG to increase process efficiency through a robust process development effort focused on simplifying, integrating, and automating their manufacturing workflow. Alligator Bioscience AB develops antibody-based pharmaceuticals for cancer treatment, specializing in mono- and bispecific antibodies for tumor-directed immunotherapies. The company is active in early stages of drug development, from early concepts to clinical phase II studies. Our collaboration with Alligator resulted in the development of an efficient downstream purification process for a cancer immunotherapy bispecific antibody (bsAb). A two-step purification protocol was further developed to increase the process economy. We are joining Germfree to develop a fully integrated, expandable manufacturing solution for emerging biotherapeutics — including gene therapy. Current market indicators predict a compound annual growth rate of more than 36% in the cell and gene therapy