With the demand of higher production and reducing cost in biological manufacturing, continuous bioprocessing is replacing the traditional batch-mode manufacturing. Many biopharmaceutical companies are seeing the benefits of continuous processing. Novasep has enabled fully integrated continuous bioprocessing — from perfusion bioreactor to formulation. Objective This application note highlights a study conducted with Novasep’s BioSC Lab® technology for a fully continuous monoclonal antibody (MAb) production. BioSC Lab® is a sequential multicolumn chromatography (SMCC) system integrated as the capture step using protein…

Since the introduction of single-use technologies (SUTs) more than 20 years ago, their benefits have been well recognized, and their adoption has been swift. The ability to customize a solution for every operation, every scale, and every product is an attractive proposition when compared with the fixed, stainless-steel facilities SUTs have replaced. But now customization has gone too far. Custom assemblies are being used when there is no need or benefit, and excessive customization is becoming a key challenge of implementing…

Since 1987, Prometic Bioseparations Ltd. (PBL) has been pioneering the design, development, and manufacture of affinity purification technology for laboratory-scale and industrial-scale bioprocessing. With 30 years’ experience in the development of affinity products and design and manufacture of new custom adsorbents, PBL is a world leader in its field. PBL offers an extensive range of off-the-shelf bioseparation products for the recovery and purification of biologicals and the removal of problem contaminants. We also offer a range of semidisposable bioprocess columns…

Single-chain variable fragments (scFv) are antibodyderived molecules with several advantages over full-length IgGs, including rapid target access and good tissue penetration. Straightforward and efficient capturing solutions similar to protein A for monoclonal antibodies (mAbs) may pave the way for the future success of this class of molecules. Herein we describe general conditions for capturing scFv from Escherichia coli with TOYOPEARL® AF-rProtein L-650F and subsequent optimization to achieve efficient purification. General Guidelines for CapturinG The κ light chains of mAbs, Fabs,…

AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people, and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology, and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. Combining the focus of a biotech with the…

Althea is a fully integrated contract development and manufacturing organization providing clinical and commercial drug product services. Althea offers cGMP drug product filling in both vials and syringes and production of microbial-derived recombinant proteins and plasmid DNA. Comprehensive development services are available, including upstream and downstream process development, analytical development, lyophilization, complex formulation, product release, and ICH-compliant stability testing. Althea offers a proprietary formulation technology platform, Crystalomics®, and Corynex® protein expression technology. Login to read the full PDF of the…

Avid Bioservices is a contract development and manufacturing organization (CDMO) specializing in mammalian cell culture process development and cGMP production of clinical and commercial-scale monoclonal antibodies, recombinant proteins, and enzymes. Committed to the success of our clients, our team constantly strives to build partnerships that extend well beyond the delivery of your product. By combining our knowledge and experience with a flexible and efficient approach, we can meet your specific project requirements. Established CDMO with a Broad Range of Capabilities…

The analytical field for biologics has evolved greatly over the past 30 years, and the underlying growth has shifted from biopharmaceutical companies to contract research organizations (CROs). The global biopharmaceutical market is growing annually at >15%, making it the largest and consistently fastest growing segment of the healthcare industry with annual sales in excess of US$200 billion. Contract manufacturing organizations (CMOs) are expanding capacity by building new cost-efficient facilities, reflecting market demand. Many product sponsors are outsourcing, some even increasing…