Guest Columns
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Emerging Trends & Technologies In Anti-Counterfeit Pharmaceutical Packaging
11/21/2023
Counterfeit medicines are rising at an alarming rate, with data showing that nearly 6,500 pharmaceutical crime incidents were recorded in 2021, ranging from innovator drugs to generics, and from antimalarials to blood pressure medicine to vaccines. What packaging and labeling strategies are pharma/biotech companies using to tackle this?
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Outsourcing And Phase-Appropriate GMP For Clinical Manufacturing Needs
11/20/2023
Appropriate manufacturing and timely delivery of investigational products are essential for the successful execution of clinical trials. This article shares best practices working with CDMOs as well as phase-appropriate GMP of the clinical supply.
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A Brief Introduction To Environmental Monitoring For Startups
11/17/2023
Environmental monitoring is a crucial part of the pharma, biotech, and medical device field to indicate that the microbial particulate content of all cleanroom air and work surfaces is below acceptable levels. For new startups with a small number of employees wearing many hats, you might not have a deep understanding of what kind of monitoring is available, so this article shares an introduction.
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Why Lactococcus Lactis Might Be The Best Membrane Protein Factory
11/17/2023
The bacteria lactococcus lactis has emerged as a promising alternative expression system for membrane proteins, which are difficult to manufacture. L. Lactis is inexpensive and easy to grow. It also doesn't produce endotoxins, which makes it a good fit for therapeutic applications.
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Leveraging An Application Managed Services (AMS) Provider For Pharma/Biotech Serialization Systems
11/16/2023
With the expansion of serialization requirements, including the need for Drug Supply Chain Security Act compliance, many pharma/biotech companies are turning to serialization technology systems to help them manage those specifications. This article shares the key benefits of leveraging an application managed services (AMS) provider as well as key considerations for selecting a provider.
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Building AAV Manufacturing Capacity For Large Patient Diseases
11/15/2023
AAV-based gene therapies are poised to treat larger patient populations with diseases like cardiovascular and neurological conditions. But scaling poses safety and manufacturing challenges. This deep dive into the issues could help companies clear away some of those obstacles.
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Modular And Single-use Tech Driving The Future Of Biomanufacturing
11/14/2023
BioPlan's 2023 Biopharmaceutical Manufacturing Report shows an increasing demand for single-use and modular manufacturing systems for traditional biologics like mAbs. It also confirms that these technologies become even more critical for advanced therapeutics where small-scale applications may be the only option.
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Your Local Affiliates Want More From Your Global Regulatory Information Management
11/9/2023
Achieving regulatory excellence depends on a combination of process optimization, effective global systems, high data quality, and better local affiliate collaboration. This article shares key takeaways from new survey results from local offices/affiliates representing 94 countries.
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What Regenerative Medicine Manufacturers Have Been Waiting For
11/9/2023
It's not revolutionary, say two FDA experts. However, the agency's new voluntary consensus standards program for regenerative medicine therapies responds to an industry clamoring for standardization. With standards that everyone agrees on, sponsors can save massive amounts of time designing protocols, and regulators can save time reviewing them.
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In Search Of The Unicorn: Do End-To-End C(x)DMOs Really Exist?
11/8/2023
Over the years, we have seen the progression of the biologics contract services go from contract manufacturing organizations (CMO) to what this expert today calls the C(x)DMO: the contract analytical/research/testing development manufacturing organization. Focusing on the mammalian biologics segment, this expert analyzed public information and a proprietary database by looking at 80 service providers supporting projects ranging from early discovery to commercial manufacturing.