Industry Insights

  1. Single-Use Tech And Sustainability: Quantifying The Environmental Impact

    In the shift to single-use technology, there is both an opportunity and an obligation to understand the sustainability impacts of this development.

  2. Making Novel Therapies A Reality Part 1

    Cell therapy, gene therapy, and RNA-based therapies. Right now, those are the classes of therapies we’re considering novel. If you look at it historically, ten years ago, recombinant proteins and monoclonal antibodies would have been novel therapies, but now they’ve become very much standardized. So now that bar has moved a little bit, and the novel therapies are really cell and gene therapies, and to a certain extent the RNA therapies.

  3. Understanding Analytical Method Validation

    During my years in analytical development science at biotechnology companies including Celera and Genentech, it became routine to develop analytical assays to test products such as proteins, monoclonal antibodies, recombinant protective antigen, DNA, RNA, etc. These tests were predominantly developed on high performance liquid chromatography (HPLC), mass spectroscopy (MS), DNA sequencers, and other state-of-the-art techniques.

  4. Shift From Central Lab To POC

    As new technologies work to change the market space, this article takes a look at the market forces that are helping and hindering the shift to zero wait time for patient test results. Comprehensive analysis of both test settings allows for better understanding of the diagnostic landscape as it exists today, offering insight to both product and process innovations for your next generation product.

  5. The Standardization Of Single-Use Components For Bioprocessing

    As single-use systems become more widely adopted, the focus in the bioprocessing industry is shifting from acceptance of the technology to standardization. While the standardization discussion encompasses many topics (including how products are tested, assembled, etc.), components are a critical area for improvement. With so many ways to apply single-use and hybrid bioprocessing systems, organizations must take action to standardize equipment in order to streamline operations and help reach the full potential of the technology.

  6. How Do You Inspect Packaging Of Bottles, Cans And Cylinders?

    To ensure the package is error free, progressive companies now use automated proofreading solutions throughout the design and printing of the package and label.

  7. Rapid Single–Step Purification Of Proteins From Whey

    Whey proteins play a vital role in the formulation of food supplements because of numerous desirable nutritional and functional properties. The objective of this study was to develop a separation process to fractionate usable proteins from whey. First, total whey protein isolate (WPI) was purified because of its high-end functional advantages, as evidenced by a demand from nutrition and health segments. Second, ALA and BLG were purified because of their value in infant formula and confections, respectively.

  8. The Direct-To-Patient Model: Your Top 10 Q&A

    In clinical trials, a direct-to-patient model allows for drug therapies to be delivered and administered in the patient’s home and/or biological samples to be taken and uplifted from the patient’s home. Depending on the complexity of the trial protocols, patients may take medicines themselves, or rely on a homecare nurse or caregiver for clinical support. Because the direct-to-patient model allows the patient to participate in the clinical trial from home, it reduces the need for them to travel to the investigator site, increasing the likelihood they will agree to participate and decreasing the possibility that they will drop out of the study.


    Manufacturing of biopharmaceuticals is a large commitment to the public health and helps save the lives of millions of people. The complex nature of biopharmaceuticals makes manufacturing a challenge, in which a consistent, high-quality end product is dependent of the use of equally consistent, high-quality key manufacturing components.


  10. Selecting The Optimal Resins For Mammalian Virus Process Purification And Clearance

    The success of biologics for use in humans depends on the ability to effectively remove any viral contaminants. Viral Clearance from biologics is critical to their performance since they can directly infect mammalian cells and cause diseases such as AIDS, mumps, measles, herpes, hepatitis, meningitis, and shingles. And, conversely, studying these disease causing viruses can aid in the development of preventive and curative therapeutics. In this article, Bio-Rad provides snapshots of the different apatite-based media that can be effectively utilized for the process-scale purification of small to mid-sized viruses.