Liquid Dose Featured Articles
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How To Mitigate The Risks Posed By "High-Risk" Host Cell Proteins
11/3/2021
Host cell proteins are process‐related impurities that may copurify with biopharma drug products. Some of these can be considered high-risk, including those that are immunogenic, biologically active, or enzymatically active with the potential to degrade molecules or excipients used in formulation. Here's how to mitigate those risks.
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Where Is Technological Innovation Needed For CAR-T Manufacturing?
10/29/2021
Investment in cell therapy biomanufacturing has continued to follow a steady upward trend. Even with the anticipated increases in capacity, there are still concerns facing current and future cell therapy manufacturing capacities, including an anticipated “capacity crunch.” This article examines where technological innovation is needed to avoid this capacity crunch.
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The Need For AI/ML In Drug Discovery, Dev, & Clinical Trials
10/25/2021
While an influx of new companies and technologies is spurring innovation in the industry, these startups are increasingly in competition for talent and capital. Although a fairly new area with respect to the use of AI, the drug design and development process is ripe for the application of machine learning and deep learning techniques.
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Computerized Systems Validation And Audit Trail Requirements
10/18/2021
A plug-and-play approach can significantly impact how we design, build, and operate biopharma facilities. Yet, innovative developments create industry adoption challenges. This article summarizes two recently released BioPhorum standards: Plug-And-Play Computerized Systems Validation Strategy and Plug-And-Play Audit Trail Requirements.
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COVID-19 Spurs Growth Of China’s Domestic Bioprocessing Suppliers
10/8/2021
Just as the U.S. and European bioprocessing supply systems have seen more robust growth than ever before, China’s domestic demands for single-use bags, cell culture media, and purification resins are all on the rise. BioPlan’s Top1000Bio database of global bioprocessing facilities has tracked industry capacity and employment growth over 15 years.
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9 Pitfalls To Avoid In Data Integrity in Pharmaceutical and Device Development & Operations
9/22/2021
The first article in this series examined 5 common misconceptions in data integrity (DI). In this article, the author now shares 9 example areas where he has seen significant DI implementation problems in pharmaceutical and medical device companies.
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Cell And Gene Therapies: Solving Six Challenges
9/20/2021
This past year has seen remarkable progress in the growth of cell and gene therapies. While advances in cell reprogramming, genetic editing, and manufacturing mean affordable cell and gene therapies for a range of diseases and uses, the go-forward path will require planning around these six major issues.
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5 Misconceptions About Data Integrity In Pharmaceutical And Device Development & Operations
9/15/2021
Data integrity (DI) issues in pharma and medical devices have always been there, but in my experience as a consultant, these issues have increased in frequency more recently, thus moving them to the forefront. In this article, I explain five misconceptions about data integrity in our industry.
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Vaccine Manufacturing: Harnessing Lab Deviations
9/8/2021
For National Immunization Awareness Month, we're highlighting timely vaccine manufacturing-centric content such as this from Tunnell Consulting's Bob Johnson. The presence of deviations may seem inevitable, yet COVID has brought to light the question of how vaccine manufacturing sites can manufacture more vaccines, more efficiently. This article explains how.
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How To Find & Manage Biotech Consultants Effectively
9/6/2021
The roles being filled by biotech consultants have grown considerably, as companies are becoming more familiar with working with consultants and more people are interested in pursuing a consultant career. But how do we find good consultants, and how do we ensure that our consultants are as committed and engaged as our full-time employees? Here's how to accomplish that.