BPI White Papers

Why, Why, Why… ELISA? A Look at the Benchmark HCP Assay

Host cell proteins (HCPs) are a primary source of impurity in biologics manufacturing. When present in drug formulations, HCPs can reduce efficacy, introduce toxicity, and increase risk of long-term immunogenicity. Understanding HCP profiles and integrating effective removal strategies are critical when developing a new biological drug, both for ensuring patient safety and fulfilling regulatory guidelines. HCP populations can be complex and structurally diverse, and most changes in upstream culture conditions affect HCP concentrations and control strategies. Accurate and reliable HCP…

Cyclic Cell Harvest with CONTIBAC® SU Filters

As the Biotech industry is moving towards single-use components, larger batch volumes and higher cell concentrations, conventional cell harvest technologies reach their limit. Depth filters, for instance, can only cope with the increasing demands by stacking more filter elements and therefore increasing the footprint and their economic burden. Hence, innovative solutions are needed to keep pushing the boundaries of the biologics production. The CONTIBAC® SU filter of DrM excels where existing technologies crumble. Unlike in any competing technology, the filtration…

Challenges Of Host Cell Protein Analysis With ELISA And How To Obtain Better Coverage Of Your ELISA Antibody Reagents

Why is host cell protein (HCP) detection and removal so critical when manufacturing biologics? Product purity and, most importantly, patient safety depends on it. Sandwich ELISA has been a favored method for HCP testing due to its high sensitivity and high throughput, but challenges and limitations exist. Coverage depends strongly on the use of antibody reagents that adequately detect and capture HCPs. In this webinar, we address effective techniques for both optimizing HCP ELISA coverage through the selection of reagents…

Effectively Securing Cell and Gene Therapies with Closed Systems

With their innovative new treatments, cell and gene therapies (CGT) are growing rapidly. But their traditional production processes don’t allow the supply of these therapies to keep up with demand. Historically, these therapies are produced for small patient populations in clinical trials using laboratory scale equipment and utilizing manual, open processes completed under laminar hoods. But manufacturers looking for more efficiency and flexibility are turning to new solutions. One key area of interest is the implementation of a closed system…

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…

Why Characterizing Protein Stability Matters For Drug Development

Characterizing a protein’s stability provides key insights into the expression, signaling, and regulatory roles of a molecule. This is necessary for numerous applications from understanding the molecular basis for certain diseases to ensuring more effective drug development. Ultimately, the stability of a protein is closely tied to its functional activity. Whether you’re just starting to learn about characterizing protein stability or you’re looking for a refresher, this guide has some helpful tips to answer why it’s important, what technologies are…

Ten important lessons the cell and gene therapy industry can take from the bioprocessing industry

It’s time to tackle the challenges of sustainable and cost-effective commercial manufacturing regarding cell and gene therapy. Cell and gene therapies have many of the same manufacturing needs as biopharmaceuticals. As a result, industry experts expect single-use technologies used in biopharmaceutical clinical trials and commercial production to play a larger role in the future development and production of cell and gene therapy. Single-use systems are already incorporated in the development of cell and gene therapies today. However, many of those…

New Features for Single-Use Pumps in Biopharmaceutical Manufacturing

Everybody has heard the axiom “time is money,” which highlights the belief that time is a valuable resource; therefore, it is better to do things as quickly as possible in order to make more money. This concept perfectly describes the current atmosphere within the biopharmaceutical industry, where drug manufacturers are struggling to overcome speed-to-market challenges in order to reap the financial benefits of an optimized patent window. In order to bring their products to market, most biopharmaceutical-manufacturing systems employ a…

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,…