Application Notes & Case Studies

  1. Mixing Selection Considerations For Pharmaceutical Tablet Coating Operations 12/29/2020

    There are various different types of pharmaceutical tablet coatings including traditional sugar-based coatings, film coatings and enteric coatings. Whichever type of coating you're manufacturing, a Silverson high shear mixer will give you a uniform, consistent mix overcoming common processing problems such as flecking caused by uneven dispersion of colorant.

  2. Lessons Learned Executing A Closed Connected Processing From Start To Finish 12/22/2020

    Biomanufacturing is under increased pressure to adapt to market demands, such as reducing costs and bringing life-saving therapies to the people who need it faster. We performed an evaluation of biomanufacturing technologies, which can potentially improve efficiencies, and offer our findings as additional data for consideration when adopting these methods. Read our recommendations from our execution of a closed and connected mAb process from design considerations to scale-up, including the small-scale modeling that directed our process at manufacturing scale.

  3. The Value Of Reliability Assessments And Benchmarketing In Life Sciences 12/21/2020

    A global medical device manufacturer sought to improve Safety, Equipment Reliability, Overall Equipment Effectiveness (OEE), and cGMP regulatory compliance by performing a plant-wide reliability and best-practice benchmarking assessment. The goal: perform a thorough reliability assessment and benchmarking against industry standards, OSHA, and cGMP requirements to establish a reliability roadmap for moving the organization into regulatory compliance and industry best practice performance

  4. Remote Work Without VPN Helps Biopharmaceutical Company Keep Drug Development On Track 12/7/2020

    Retrophin is a San Diego, CA-based biopharmaceutical company that develops life-changing therapies for people living with rare diseases. When it transitioned to a primarily remote workforce in 2015, it needed to keep its work moving forward at the same speed. Accessing the cloud-share via VPN from one end of the country to another wasn’t just painfully slow, their people were losing connection, too. They needed a solution that would help keep drug development on track regardless of the location of each team.

  5. Upstream Platform For Continuous Lentiviral Vector Production 12/1/2020

    Process scalability, lot-to-lot consistency, and the cost and supply of high-quality plasmid are some of the constraints that have made manufacturing of LVs challenging. Here, we demonstrate a high-yield LV production process, using animal-derived component-free (ADCF) media and reagents, where multiple or continuous vector harvests could be obtained from a single batch.

  6. Industrialization And Scale-Up Of Drug Delivery System 11/30/2020

    A pharmaceutical company and their product design partner were in need of a contract manufacturer capable of supporting the device development, injection molding, tooling, supply chain logistics and scale up automation strategy. The customer had developed a novel breath actuated pulmonary device and they were looking for the right manufacturer to assist them with product development refinement, samples for clinical trials and ultimately commercialization.

  7. How a Best-Practice Strategy For Sourcing Ancillary Materials Reduced Risk, Spending and Workload In A Global Diabetes Trial 10/29/2020

    It’s impossible to run a global clinical trial of an investigational diabetes drug without ancillary materials. And as one leading multi-national pharmaceutical company recently learned, managing ancillaries can be a challenge every bit as complex as the trial itself.

  8. Moisture Headspace Analysis For Efficient Scaleup Of Freeze Drying Capacity And Validation 10/21/2020

    A vaccine production facility needed to replace an old freeze dryer in an existing facility during running operations. Activity involved a scale up of freeze-drying capacity from 14 m2 to 28 m2. With the application of non-destructive feadspace moisture analysis small scale proof of concept studies were used to minimize project risk and the number of full-scale runs in the freeze-drying validation process.

  9. Delivering Clinical Trial Medications Direct-To-Patient 10/15/2020

    In a perfect world, patients enrolled in clinical trials would live a short distance from the investigator site where they receive their treatment. Unfortunately, that is not always the case. In recent years, the direct-to- patient model, which brings medical procedures to a patient’s home, has emerged as a solution for sponsors to increase patient recruitment and retention in clinical trials.

  10. Electronic Lab Notebooks - Implementing Next-Generation Laboratory Informatics 10/11/2020

    Electronic Lab Notebooks are a key component of an electronic lab environment that helps scientists execute faster, more informed, high-quality science. It’s a vision scientists have talked about for decades.