Bioprocessing White Papers

1. The Role Of CDMOs In Cell And Gene Therapy Process Development 8/5/2020

   Even for experienced teams, it can be tricky to balance the efforts of reaching the first clinical trial using a manual, open method with building a more commercially suitable process. To accelerate their clinical and commercial programs, companies are choosing to work with contract development and manufacturing organizations (CDMOs). In this article, we highlight key areas where CDMOs can help companies get started in the world of CGT manufacturing. We also discuss when to engage with CDMOs to maximize commercial and clinical success.

2. Using Quality By Design For Process Development And Scale-Up Of A Novel ALS Drug Product 8/4/2020

   Thermo Fisher’s stepwise approach to Quality by Design (QbD), an approach that drives consistent quality into manufacturing, became integral to the success of Amylyx's AMX-0035 campaign. 

3. Three Ways To Successfully Scale Up Your Bioprocessing Production 8/4/2020

   It is crucial that, when developing a process for the manufacture of a biopharmaceutical, technology is used at small-scale which can be scaled alongside the process in a consistent manner. Here are four important steps R&D scientists, production engineers, and other bioprocessing specialists can take to facilitate a smoother and more efficient tech transfer.

4. Demystifying Extractables Testing 8/3/2020

   It's critical anyone utilizing single-use technology understands the differences between the various guidances available for extractables analysis and which testing approaches are suited to the study goals.

5. Integrated Technologies To Accelerate Process Intensification For Viral Vaccine Manufacturing 7/23/2020

   With the increasing world-wide demand for viral-based vaccines (VBVs) which includes attenuated and inactivated viral vaccines, as well as viral vector vaccines to protect against the coronavirus known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), faster development times are required to progress VBVs more rapidly into clinical development and then to market. To facilitate process intensification of VBVs including SARS-CoV-2 vaccine candidates, an integrated portfolio of technologies developed by Sartorius is detailed in this article

6. How Pandemics And Outbreaks Have Influenced The Adoption Of Single-Use Vaccine Manufacturing 7/21/2020

   In the last decade, biopharmaceutical industries have had to mobilize quickly in response to pandemics. Vaccine development typically requires many years and manufacturing large doses in an emergency is a challenge. To reduce investment risk, biomanufacturers wait until a vaccine is in the advanced stages of testing before starting to manufacture. This conventional development strategy compresses during a pandemic. Read our white paper to learn more.

7. The Integrated Pharmaceutical Development Platform: Transform The Commercialization Of Innovative Therapeutics 7/21/2020

   This whitepaper introduces the concept of the electronic Development Record (eDR) and how a holistic, platform approach to the capture, management and re-use of product and process data can propel the development process forwards, reduce costs, improve quality and enhance corporate image.

8. Agile Process Development In Biopharmaceuticals 7/21/2020

   A lack of consistency in the capture, management and analysis of data is a barrier to both collaboration and understanding, and hampers the development of novel products and processes.

9. Is Your Informatics Infrastructure Ready To Externalize R&D? 7/21/2020

   How to overcome the challenges the shift from internal to external, or virtual, R&D teams poses.

10. Expanded Access And Commercial Packaging Strategies For Orphan, Niche, And Low-Volume Drugs 7/20/2020

    Most commercial contract drug packagers do not provide consistent scheduling for low-volume drugs, which creates supply challenges. In fact, a drug packaging delay can create a market shortage that triggers serious health consequences for patients who rely on the drug. This issue can arise with niche and orphan drugs, as well as any other drugs packaged in small volumes. Conversely, a clinical supply partner can provide packaging as needed, plus handle distribution for expanded access and general commercial needs. This summary describes low-volume drugs, examines commercial packaging and supply challenges, and explores potential solutions.