Upstream

Octet® Bio-Layer Interferometry Systems: Advancing Development of Coronavirus Vaccine and Therapeutics

Development of vaccines and therapeutics to target outbreaks of infectious diseases such as SARS-CoV-2 requires speed and agility. An essential part of this rapid response are technologies designed to streamline and accelerate workflows while delivering high quality data for informed decision-making. This compendium of applications demonstrates the use of the Octet® label-free platform utilizing bio-layer interferometry (BLI) technology to advance development of coronavirus vaccine and therapeutics. The fluidic-free approach offers important advantages over microfluidics-based technologies such as surface plasmon resonance…

Edata Exchange – Embark On Your Digital Transformation Journey

You need the right data at the right time from your supplier to make important production and supply chain decisions to achieve your Biopharma Manufacturing goals. Now you have the eMERGE™ Program, our standard platform for the exchange of electronic data. It provides key raw material data, electronically, for every shipment, so you can start making informed decisions right away.

Vero Cell-based Vaccine Production: Cell lines, Media and Bioreactor Options

The recent Covid-19 pandemic introduced new challenges for the vaccine industry, it has also brought in new innovations in vaccine development including DNA/RNA based vaccines. The pandemic also increased the demand for well-established cell-based vaccine production technologies. The article reviews strategies for optimizing Vero cell-based vaccine production using rabies and influenza as examples. The Vero cell line is one of the most satisfactory vaccine production hosts based on its infectability, stability and well-documented performance in quality and quantity of viral…

Early Selection of Optimal Clones Made Easy: A New, High-Throughput, All-in-One Solution for Mannose Glycans Screening and Assessment of Critical Quality Attributes

Glycosylation is a critical quality attribute (CQA) and imparts properties such as stability, folding, solubility, cell-cell interaction and adhesion to proteins. Antibody glycosylation for example is critical due to the role carbohydrates play in modulating effector functions which affect safety and efficacy of therapeutic antibodies. The NEW Octet® GlyM Kit is designed to provide cell line development and upstream bioprocessing Octet® users with a ready to use kit for the rapid screening of % mannose content of purified and cell…

Setting the Stage for Electronic Data Exchange

Every day, drug manufacturers must consider and address a wide range of challenges and prospects including complex regulatory requirements, intense cost pressures and the business opportunities offered by novel product classes. Transforming biopharmaceutical manufacturing with integration of intensified, continuous, predictive and autonomous operations is one solution that holds promise for streamlining operations, exploring new therapeutic modalities and meeting regulatory expectations which continue to evolve. Digitization and automation, key elements of Bioprocessing 4.0, will be essential for this transformation, in which…

CHO Cell Culture Media & Feeds

Media selection is a crucial step in optimizing and maximizing your upstream process. Our chemically defined catalog media portfolio offers a comprehensive range of off-the-shelf products to support all of your CHO production processes, including fed batch and perfusion mode. Learn more.

A Smart Path for Novel Biologics

Roche Pharma Research and Early Development (pRED) was faced with a challenge: double the number of projects in process development without significantly increasing headcount. Pawel Linke, a pRED lab automation specialist, tells the story of how the group approached this challenge with a focus on obtaining high quality data through automation and by integrating independent lab systems and devices to streamline their workflow. Implementation of high-throughput process development systems requires an orchestrated approach of both hardware and software solutions, so…

Writing the Future of Biologics to Discover and Optimize Antibodies

With our unique DNA writing technology, Twist Biopharma is accelerating the way our partners discover and optimize antibody therapeutics. We have decades of synthetic antibody library design and selection expertise and have the ability to write any DNA sequence to enable faster, better discovery and development. Using our precise, rational, expertise in library fabrication, we can create libraries in a fundamentally different way that allow us to address tough targets, e.g. GPCRs. Since we are a DNA product company, we…

Understanding and Controlling Raw Materials Variation in Cell Culture Media

The FDA requires biopharmaceutical manufacturers to understand and control sources of variation according to the risks they present to process and product. Cell culture media and feeds have been shown to affect cellular performance, product quality, or both. The evolution of media formulas to those that are serum-free and chemically defined poses both a challenge and an opportunity. The challenge is identifying which of the many components have the greatest impact on cells and the molecules they produce. The opportunity…

Analytical Power Tools Open Upstream Bioprocessing Bottlenecks

The blockbuster success of antibody-based therapeutics for autoimmune diseases, inflammatory diseases and immuno-oncology accelerated the high stakes monoclonal antibody (mAb) development race. Clone selection is a significant upstream bottle-neck slowing bench-to-bedside development progress for new mAb-based therapeutics. Cy-Clone™ PLUS, a validated assay kit accelerates human mAb production cell-line generation, significantly reducing the time to industrial-scale productivity. Cy-Clone PLUS assay combined with the Intellicyt® iQue platform and integrated ForeCyt® Software are powerful analytical tools that inform rapid go/no-go decisions with multiparameter,…