Insights On Outsourced Drug Development

1. Precise Control Of Gas Flows Within The BIOSTAT® B-DCU 7/9/2019

   To meet the oxygen demand of cells a stable pO₂ control is an essential part of every cultivation. The objective of this application note is to demonstrate the performance of a new generation of mass flow controllers in the BIOSTAT^® B-DCU bioreactor system. Several comparative cell cultivations were performed.

2. Integrated Tools For Upstream Process Intensification: Part II 10/27/2019

   Changes to bioprocessing methodologies in the biopharmaceutical industry are being driven by the need for increased speed, a lower cost of goods (COGs) and greater flexibility. Faster development times are required to progress biologics and vaccines more rapidly into clinical development and then to market to improve worldwide accessibility. Continue reading in part 2 of this series how in order for intensified and continuous bioprocessing to deliver on these quality and productivity promises, there is a requirement for intelligently designed products.

3. Viral Clearance: 7 Chromatography Column Considerations 6/24/2019

   Viral clearance studies are a critical part of the production of biologics. Here are seven things to consider while performing your next chromatography viral clearance study.

4. Capture OTC Market Share For Geriatric And Pediatric Patients 8/15/2019

   This webinar discusses how the unique properties of gelatin have been used to develop chewable softgel formulations for the pediatric and geriatric patient populations. 

5. Industry Trends In Biologic Formulations 7/12/2019

   In 2018, we saw a record-setting year for new-molecular entity (NME) approvals (59) at the FDA1 versus 46 in 2017. 58% were for orphan drugs (patient population less than 200,000 in the US) with 17 biologic-based NME’s. Biosimilars are gaining traction in Europe, in particular. Major factors that are driving the market growth are next-generation business, high growth in chronic diseases, less expensive biosimilar drugs and favorable government regulations.

6. Scaling A mAb Production Process To A Single-Use Platform 9/27/2019

   The transfer of mAb production processes between scales, referred to as scale-up or scale-down, is difficult. This study reviews moving mAb production from a microscale bioreactor to a single-use platform.

7. Optimize Manufacturing Using Comprehensive Powder Characterization 11/25/2019

   Understanding the range of powder behavior characteristics through measurement of the most appropriate properties is essential for efficient processing and consistently high-quality finished products.

8. Key Considerations For A Successful EU Orphan Drug Launch 7/22/2019

   During this interactive webinar, the speakers involved will utilize their experience to guide you through the EU product launch process, from submitting your Marketing Application (MA) to final distribution of drug product to the end-user.

9. Automated Glucose Control 7/9/2019

   Within this application is an example method on how to establish glucose feed control is documented and as well as highlighting the key benefits of applying this method to other processes.

10. Data Gathering And Analysis Necessary In New Tablet Development 9/6/2019

    A significant concern in tablet manufacturing is speed to market. Moving too quickly, however, may cause delayed production, lost product, and missed deadlines. To reduce potential headaches, companies are embracing the principles of Quality by Design (QbD) and utilizing automated data gathering and tablet analysis during research and development. This allows organizations to reduce product development and delivery stress and loss.