1. A Working Introduction To Six Sigma For Pharmaceutical Manufacturers

    This is the first in a series of articles on Six Sigma that will introduce you to this methodical, rigorous approach to process excellence, and share the author's experiences using the technique in the pharmaceutical industry.

  2. Early Implementation Of Quality By Design For Biological Product Development

    The idea of thinking in terms of “operational excellence” is a relatively new idea for the biopharmaceutical industry. The enormous uncertainty associated with bringing a biological drug product from discovery to approval almost precludes the thought of forward-thinking in terms of what makes a quality product, especially during early-stage development. However, extensive product knowledge is gathered during early development, and crucial decisions are made in terms moving the science forward to generate the data required to meet your business objectives.

  3. Continuous Processing Optimization With Smarter Tools

    Due to a paradigm shift in the pharmaceutical industry, there is rising pressure to come up with faster, more cost-effective ways to produce drugs for the patients who need them.

  4. Anti-TNF Biosimilars In Europe: What Matters Beyond Price?

    The recent introduction in Europe of biosimilar anti-tumor necrosis factor (anti-TNF) drugs has attracted considerable attention. Much of the commentary to date has centered on price, but price tells only part of the story. Structural and perceptual differences have led to considerable heterogeneity in the levels of discounting, access, and uptake throughout and even within European markets.

  5. Biologic Manufacturing Capacity Expansion With Single-Use Technologies

    The following presentation is based on a simulation of a 2 × 2000 L mAb process. The simulation compares a single-use process train (SU) with a comparable stainless steel-based process train (SS), both modelled in a traditional, stick-built facility.

  6. Transformations In Biomanufacturing

    In biomanufacturing the only certainty is risk and the only constant is change. Technology is pushing new frontiers, new markets are opening up across the globe, and new competition is creating new levels of urgency—all under the ever more watchful eye of regulators.

  7. How To Simplify Reliable Protein Production In Insect Cell Applications

    Simplified and reliable protein production from an insect cell baculovirus expression vector system (BEVS) using single-use ReadyToProcess WAVE™ 25 bioreactor system

  8. How A Single-Use Stirred-Tank Fermentor Performed With Microbial Fermentation

    This application note describes the performance of the Xcellerex™ single-use XDR-50 MO stirred-tank fermentor in an E. coli domain antibody (Dab) production process developed for a stainless steel fermentor. Cell growth, cell density, and Dab expression levels were assessed and compared between the two production vessels. The results show that the performance of the XDR-50 MO fermentor is comparable with that of the reference stainless steel fermentor.

  9. Improve Throughput And Cost With Continuous Downstream MAb Processing

    In this study, periodic counter current (PCC) chromatography and straight-through processing (STP) technologies were evaluated in a continuous three-step monoclonal antibody (MAb) purification process.

  10. Liquid Chromatography System For Scale-Up Biomanufacturing: ÄKTA Datasheet

    ÄKTA ready is a liquid chromatography system built for process scale-up and manufacturing. It is part of the ReadyToProcess platform, a suite of plug-and-play, ready-to-use solutions for bioprocessing.