Application Notes & Case Studies

1. Oxygen Monitoring Of Sensitive Formulations 6/3/2020

   Pharmaceutical formulations, especially delicate large molecule biopharmaceuticals, may have some level of oxygen-sensitivity leading to degradation of the active pharmaceutical ingredient. Laser-based headspace oxygen analysis enables accurate, efficient determination of oxygen consumption curves. Accurate measurement of the oxidation rate supports the determination of headspace oxygen specifications and end-of-shelf life stability.

2. Oxygen Monitoring During Quality Stability Testing 6/3/2020

   A manufacturer of a syringe product received complaints about discolored product that was nearing the end of shelf life. A root cause investigation was started and product syringes were put on stability. The headspace oxygen levels were monitored over time. The laser-based headspace analysis proved to be a useful tool to check package integrity and for the presence of reactive headspace gases that can degrade the formulation.

3. Filling Line Nitrogen Purge Qualification In Manufacturing 6/3/2020

   A client had an existing filling line and wanted to optimize the nitrogen purge process to decrease headspace oxygen levels to 2%. In addition, frequent line stoppages resulted in a need to identify and reject high oxygen vials that had lost the nitrogen headspace during the stoppage. A purging process qualification study was performed using rapid non-destructive headspace oxygen analysis in an at-line set-up with samples being measured immediately from the line.

4. Lipid-Based Formulations For Early-Stage Clinical Trials 6/1/2020

   For certain molecules, the most appropriate technology for bioavailability enhancement and accelerated development will be lipid-based formulations (LBF), supported by in silico development tools. Senior Formulation and Product Development Scientists analyze the potential benefits and applications of lipid/liquid-based formulations and how they may reduce timelines to clinical trials.

5. CAR-T Cell Lentiviral Transduction By Spinoculation 5/21/2020

   There is a growing need to close and automate manufacturing of chimeric antigen receptor (CAR)-T cell therapies. CAR-T workflows depend on ex vivo gene transfer by lentiviral transduction for therapeutic efficacy. To streamline this step while keeping flexibility during process development, we introduced stand-alone SpinOculation C-Pro protocol software.

6. Contract Pharmacal Corporation Installs X-Ray Inspection And Checkweighers For Brand Protection And Quality 5/12/2020

   CPC develops, manufacturers and packages premium pharmaceuticals, over-the-counter drugs and dietary supplements. Since five of their lines package product in a foil-laminated film, which disrupts traditional metal detector, they need to implement x-ray systems for those lines.

7. Catalent Keeps On Track In Compliance With Track & Trace Solutions 5/12/2020

   Catalent Biologics works closely with its customers from early development through commercial supply. To comply with serialization regulations, Catalent’s Bloomington, Indiana, USA team needed an affordable Track & Trace solutions that could be easily added to their vial and syringe packaging suites.

8. Liquid Retention Comparison In PC And PETG Containers 5/8/2020

   Fluid retention is an important consideration when choosing a container. The physical design and material of construction of the container impact how much fluid remains after dispensing. Fluid retention is an important consideration when choosing which container to use. This application note is a comparison between different container products.

9. NovaPure® Components: A Proactive Approach To Reducing Particulate Risk 5/6/2020

   A biotechnology company that manufactures injectable large molecules was seeking to evaluate elastomeric components that would help them to attain the highest quality standards for their manufacturing lines. The company took a proactive approach to meeting and exceeding regulatory guidelines concerning the cleanliness of their lifechanging medicines and were keen to learn how a supplier’s tight packaging specifications could help them with their approach.

10. Biopharmaceutical Company Selects West’s NovaPure® 1mL Long Plunger For First Commercial Drug Launch 5/6/2020

    A small biopharmaceutical company looking to launch their first drug, reached out to West Pharmaceutical Services, Inc. seeking recommendations for packaging solutions for one of their pre-clinical drugs. With limited resources and little expertise in containment and delivery of injectable medicines, they needed an experienc Download the case study for the full story.