Rapidly increasing demand for cell-derived products has placed huge pressures on the biomanufacturing industry’s production capacity requirements. Media development strategies continue to be a primary focus for optimizing output from cell culture systems. Animal cells used in manufacturing protein products have complex nutrient requirements specific for each cell type, clone, and product. Individual nutrient requirements were once addressed by using serum-based media rich in growth factors and supplements, which provided an optimal culture environment for cell growth and productivity (1).…
Search Results for: antibody characterization
Localized Surface Plasmon Resonance for Bioprocess Development, Monitoring, and Validation
Academic laboratories have embraced localized surface plasmon resonance (LSPR) as the “new wave†of label-free technology (1). This technique is based on the ability of colloidal metal nanoparticles or nanostructured metallic films to absorb light in a narrow wavelength range. Metal nanostructures “sense†changes occurring at their surfaces by shifting the frequency of the light they absorb or reflect. As a consequence, a basic LSPR system requires only optical fibers, a source of white light, and a detector…
Exchanging Real-World Solutions to Improve Speed, Cost, and Predictability BioProcess International Conference & Exhibition
The BioProcess International Conference is your one-stop industry resource for driving down costs; improving quality; and achieving rapid, robust, and resilient process development and manufacturing. This is where challenges are explored, solutions are uncovered, and opportunities are developed — at the largest and most highly respected event solely dedicated to biopharmaceutical manufacturing. New This Year New, unpublished data in every conference session Reports from the FDA, EMA, and leading industry players on biosimilars and biobetters Sessions on managing global manufacturing…
Althea Technologies, Inc.
Althea is a contract developer and manufacturer of biopharmaceutical and injectable products, with fully integrated product development and cGMP manufacturing expertise to support client projects from preclinical development through commercial supply. Each project program at althea is tailored to the specific needs of your product, allowing you to leverage our entire integrated manufacturing approach, or just the parts you need. While realizing all of the tangible benefits of consolidating your development and manufacturing steps, you’ll…
Capacity to Accelerate Success
As a CMO partner, Avid Bioservices provides fully integrated services across the process chain to develop and commercialize a biologic including cell line and process development, analytical methods development, clinical and commercial cGMP manufacturing, and regulatory submissions. We provide first-hand expertise and knowledge to navigate a biologic from concept to commercialization because we are a wholly owned subsidiary of Peregrine Pharmaceuticals, a clinical-stage, publicly traded biotech company with a management team experienced in the development and commercialization of therapeutic proteins.…
Increase Efficiency and Accelerate Protein Workflows with the LabChip GXII
Vaccine engineering, antibody quality screening, and glycosylation profiling processes can generate large quantities of protein samples that must be analyzed in a timely manner. Generation of high-quality data and rapid, quantitative analyses are mandatory to determine next steps. Although still heavily relied upon, sodium dodecyle sulfate polyacrylamide gel electrophoresis (SDS-PAGE) is labor-intensive and only semiquantitative, and its throughput capacity is limited. Quantitative analysis techniques such as capillary electrophoresis (CE) and high-performance liquid chromatography (HPLC) do not provide the throughput necessary…
Rapid Cell Line Development with Integrated Protein Analysis
The standard cell line development pathway at many contract service organizations is based solely on selecting clones by growth and productivity with little or no analytical characterization of the expressed protein. The use of protein analytics to support selection of clones that match desired product quality is important for second-generation processes and will be of utmost importance for biosimilar development. CMC Biologics performs sophisticated protein characterization using state-of-the-art analytical equipment combined with our robust cell…
A CMO’s Approach
Industry leading biologics contract manufacturer Fujifilm Diosynth Biotechnologies located in Research Triangle Park, NC (formerly Diosynth Biotechnology) and in Billingham, UK (formerly Avecia Biologics) provides third-party contract development and manufacturing services to the biopharmaceutical industry. Fujifilm Diosynth Biotechnologies has supplied clinical and commercial recombinant proteins produced in cell culture for more than 14 years. We have extensive experience in microbial development and manufacturing and equal experience in the cell culture space. Our development experience includes…
Vivalis CMO Services
Since 2006, Vivalis has operated and maintained a GMP manufacturing facility for the production of monoclonal antibodies, recombinant proteins, and viral-based products. Founded in 1999, Vivalis has developed a series of innovative technologies to address the needs of biopharmaceutical development. These include novel cell substrates, such as our avian EB66® cell line, which has seen wide application in areas from vaccine manufacturing to monoclonal antibody development. Our CMO services not only include those for clients using the EB66® cell line,…
Glycosylation of Therapeutic Proteins
ACMC Strategy Forum held in Washington, DC, on Sunday 28 January 2007, focused on two topics related to protein structure and function. First, analytical techniques used in the glycan analysis characterization included recent advances and correlations among the various tools. And second, current understanding glycosylation’s functional relevance to therapeutic proteins was discussed in the context of its effects on biological activity, pharmacokinetics, and Fc effector functions (for monoclonal antibodies, MAbs). Progress has been made in the field of…