Industry Insights
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Safe Transportation Of Temperature-Sensitive Blood Products, Part One
6/10/2016
Blood products continue to increase in cost, and loss of product due to logistical issues, transportation equipment failure, or other transport difficulties can create not only financial problems, but also impact costs measured in human lives. However, using the appropriate cold chain solutions can help address many of the issues related to storage and transportation of blood products.
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Trends In Bioprocessing CDMO Selection
Learn which CDMO characteristics experienced outsourcers value most from ISR’s Bioprocessing Market Trends and Outsourcing Dynamics report.
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Microorganism Challenges On Online Water Bioburden Analyzers: Pitfalls & Best Practices
3/2/2020
This the second article in a two-part series on conducting microorganism challenge studies using online water bioburden analyzers (OWBAs) in a laboratory setting. Part 1 discussed two different experimental approaches that have been successfully used for microorganism challenges. This second article explores the six pitfalls to avoid and four best practices to follow during execution of microorganism challenge tests.
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An Overview Of The 9 FDA Special Designations For Pipeline Drugs
9/8/2023
The FDA employs special designations to streamline and incentivize the advancement of drugs addressing medical gaps. Some designations can accelerate FDA timelines for NDAs and BLAs, others may abbreviate the duration of clinical trials. What scenarios or drugs/therapies are best suited for each?
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Simplifying Outsourcing For Complex Formulations
In a recent webinar, experts from Ajinomoto Bio-Pharma Services explored the necessary components of a tech transfer for LNP-based drugs, including the outsourcing strategies needed to avoid pitfalls.
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The Patient-Centric Clinical Supply Chain For Cell And Gene Therapies
8/1/2022
This article explores how delivering cell and gene therapies to patients requires new levels of agility, flexibility and innovation in the logistical management of supply.
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FY2017 FDA Drug Inspection Observations And Trends
4/18/2018
This article presents the most recent publication of GMP drug product inspection data from the FDA's Center for Drug Evaluation and Research (CDER), which addresses drug inspections conducted in FY2017. It looks at five years of data from the FDA, examines data from 2017, and evaluates five years’ worth of trends in GMP inspection enforcement.
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Creating A Compliant eCTD: Avoiding Common Regulatory And Technical Pitfalls On The Path To Submission
7/27/2020
Failure to comply with the regulatory and technical requirements when creating your eCTD could jeopardize the success of your submission and your product development plan as a whole, especially for early-stage biotechs. Here are strategies for avoiding some of the most common electronic publishing pitfalls on the path to submission.
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Gene Therapy: Commercial Challenges And Strategic Choices
5/16/2019
Innovation in gene therapy brings the potential for transforming patient care and obviating the need for chronic therapy through single-dose cures. Despite the potential long-term benefits of this new therapeutic modality, gene therapy companies face a number of underappreciated challenges.
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Keep Integration Of Clonal Workflow Technology Easy For Busy Laboratories
1/14/2022
When it comes to expanding your lab’s capacity, updating existing methods or even starting from scratch you need new technology integration to be simple, quick and professional.