Guest Columns

1. The “New Normal”: Changing Perceptions on Bioprocess Intensification and Continuous Bioprocessing 3/1/2021

   Process intensification and continuous bioprocessing are concepts without clear, consistent definitions. What may be included (or not) often varies greatly and, in some ways, has become more about aspirational goal-setting than actual innovation adoption. BioPlan Associates, Inc. has assessed the changing perspectives of 122 bioprocess decision-makers in this survey, now in its 18th year.

2. Germany’s Digital Medical Device Regulations: A Framework For The World To Follow, Part III 2/26/2021

   Germany's BfArM, or the Federal Institute for Drugs and Medical Devices, released a new guide in August 2020 detailing the requirements for digital health application manufacturers in order to make your DiGAs available to the more than 73 million participants in the German statutory health insurance. In this concluding article in the series, John Giantsidis of CyberActa, Inc. delves into the interoperability, robustness, consumer protection, and patient safety requirements. Other countries will likely soon follow Germany's example.

3. Important cGMP Considerations For Implementing Electronic Batch Records 2/26/2021

   Mistakes in batch records can have considerable consequences for the release of medicines in terms of delays and rejections. Errors can be minimized through the implementation of electronic batch records. However, with any electronic system within the pharmaceutical industry, the requirements of current good manufacturing practice (cGMP), including those of data integrity, need to be met. 

4. Incorporating Excipients Into QbD Studies For Drug Development — An Introduction 2/24/2021

   This article is the first in a three-part series based on information from the new guide Incorporation of Pharmaceutical Excipients into Product Development using Quality-by-Design, published by the International Pharmaceutical Excipients Council Federation. Topics covered include measuring the impact of excipient variability on finished product quality and more!

5. Cell and Gene Therapies Are Driving Investment Opportunities 2/23/2021

   As technology advances in cell and gene therapy and investment continues in these technologies, life-changing and life-saving neurological therapies are an option available to anyone who needs it.

6. FDA Steps Up Support For Advanced Manufacturing Technologies 2/22/2021

   In its latest move to encourage the broader adoption of advanced manufacturing technologies, the FDA has entered into a memorandum of understanding (MOU) with the National Institute of Standards and Technology (NIST) that combines the strength of FDA’s regulatory expertise and NIST’s globally recognized precision characterization and standards. The MOU is significant because it takes the next step in providing much-needed guidance and resources to the industry.

7. Answer These 3 Questions Before Developing Software As A Medical Device 2/22/2021

   Whether your organization is interested in software adoption to build in continuous data acquisition, offer remote care capabilities, improve patient engagement, or simplify routine clinical tasks, software as a medical device (SaMD) is at the center of it. Before getting started on your SaMD project, answer these three questions.

8. FDA’s COVID-19 PREPP Initiative Summary Report — Key Takeaways For Manufacturers 2/19/2021

   Published in January 2021, the FDA COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) Initiative Summary Report is the culmination of work performed by the FDA’s PREPP Initiative, which launched in April 2020 to examine lessons learned from the agency’s response to the global COVID-19 pandemic. This article provides a brief overview of the report’s overarching themes and highlights key regulatory insights for manufacturers in light of two action areas in particular.

9. Philadelphia’s Talent Pipeline Collaborative Readies Region For Cell And Gene Therapy Job Growth 2/18/2021

   On the heels of a 2020 study predicting substantial job growth in the cell and gene therapy sector in Greater Philadelphia, industry leaders in our region have created the Life Science Talent Pipeline Collaborative to ensure a strong talent pool for the future. 

10. Developing Future Delivery Models For ATMPs: Practical Considerations 2/17/2021

    With a small number of approved cell therapies/ex-vivo gene therapies, and with those approved therapies reaching small patient populations, there is not a proven strategy to answer the questions about large-scale commercial manufacturing. The developers of these processes are taking different strategies for commercial manufacturing as they weigh several factors.