Application Notes & Case Studies

1. Oxygen Sensitive Product: Comparing Oxygen Testing Methods 3/7/2021

   The accurate determination of oxygen concentration as a critical quality parameter for oxygen-sensitive products is important across the product life cycle activities. Traditional methods for determining headspace oxygen levels in parenteral containers, such as electrochemical methods or gas chromatography, are slow and destructive. This article describes several case studies comparing non-destructive laser-based oxygen headspace analysis with electrochemical oxygen analysis and gas chromatography.

2. Generating Robust Residual Seal Force-CCI Correlation Data To Ensure CCI Of Vials Requiring Deep Cold Storage 3/3/2021

   The increased implementation of deterministic analytical methods for container closure integrity (CCI) testing has enabled deeper insight into the performance of primary packaging with respect to CCI. However, ensuring good CCI of sterile injectable product goes beyond CCI testing during the product life cycle. This case study describes how packaging development and process study data of a pharmaceutical vial product requiring deep cold storage can be combined in a holistic approach.

3. Process Performance Comparison Between The 50 L HyPerforma DynaDrive S.U.B. And Legacy S.U.B. Platforms 3/2/2021

   As a molecule approaches commercial launch and more is known about the potential market demand, companies are often faced with the decision to scale up or scale out their manufacturing processes. A next-generation S.U.B., the Thermo Scientific™ HyPerforma™ DynaDrive™ bioreactor, is now enabling scale-up to 5,000 L and process intensification above previous limits while continuing to leverage benefits of S.U.B.s.

4. End-User Evaluation Of 30 L And 300 L HyPerforma Single-Use Fermentors And Scale-Down Model 3/1/2021

   In moving processes from bench to pilot and ultimately production fermentors, it is critical to have a reliable scaledown model. Scale-down models can vary depending on the media, strain, and process conditions. In this case, a customer wanted a scale-down model of the Thermo Scientific™ HyPerforma™ Single-Use Fermentor (S.U.F.) in order to establish what fermentation processes could be scaled into the S.U.F., in particular for the production of plasmid DNA.

5. Production Of Therapeutic Plasmid DNA In Single-Use Fermentors 3/1/2021

   As producers move toward single-use production to meet demand for gene-targeting biotherapeutics, we review three procedures for production of therapeutic plasmid DNA in single-use fermentors.

6. Pharmaceutical Company Quickly Transitions 28 SKUs To Comply With New Labeling Requirements 2/10/2021

   A large multi-national pharmaceutical company needed assistance in complying with new Health Canada regulatory requirements for labeling over-the-counter (OTC) products. The project scope required bringing 28 SKUs that varied by dosage form, quantity, primary and secondary packaging, as well as therapeutic area – and each SKU had its own unique packaging demands and timeline to maintain an unaffected retail shelf presence - into compliance with PLL. Read how all 28 SKUs were delivered in accordance with the forecast timelines and the overall project was completed early.

7. Addressing Challenges Of Ophthalmic Product Filling 2/10/2021

   Many innovative pharmaceutical packaging formats are being developed to meet the growing requirement for sterile, safe and secure packaging and delivery of ophthalmic products. Due to the diversity of these sterile ophthalmic medications, aseptic filling lines must be highly sophisticated and adaptable to address a variety of packaging challenges in this growing market.

8. Robotic Aseptic Processing For Filling Ready-To-Use (RTU) Vials, Syringes And Cartridges 2/10/2021

   As patient treatments move away from broad population therapies in favor of the targeted treatment of smaller (personalized) patient populations, the biopharmaceutical industry is transitioning to smaller aseptic batch manufacturing processes. Robotic solutions provide pharmaceutical manufacturers with a faster, more flexible and cost-effective way to fill different container formats using the same filling platform, responding to the growing demand for small batches, customized packaging, rapid product and format changeovers along with a less user intervention during the filling process.

9. Analysis Of Clean In Place (CIP) 2/1/2021

   There are several challenges to effectively analyzing CIP operations. Seeq Tools help create a process model that can be applied across cleaning circuits and amended with circuit-specific data.

10. Faster R&D Of Pharma Production Lines 2/1/2021

    This use case demonstrates a solution that empowers users by connecting to all relevant data sources to visually represent batches and perform analytics with process data.