Industry Insights
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The Power Couple: CRISPR And Oligonucelotides
3/4/2024
Drug design using CRISPR depends on long guide RNA (gRNA) sequences. Find out how this love match between long oligos and CRISPR works.
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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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A SMART Approach To CAPA Effectiveness Checks
3/9/2020
Many times, corrective and preventive action (CAPAs) fail due to the structure and flow of the process and not necessarily the efforts of those managing the CAPAs. This article will look at using the SMART (specific, measurable, achievable, relevant, and time-bound) methodology for use in developing a CAPA verification of effectiveness plan.
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Essential Elements Of Technology Transfer
9/19/2023
The principles of an effective technology transfer can apply at every stage of the drug development lifecycle for biotech companies of every size. Tech transfer programs are usually bespoke, but they share common essential elements. This article breaks them down.
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Protecting Single-Use Bags To Foster Their Progress
12/19/2021
There is still potential product loss with unprotected single-use bags, and there are still human errors dampening the euphoria of single-use systems. Here's how to protect your product investment.
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Survey Results Show What Could Finally Make Sustainability Stick
9/8/2023
Results from BioPlan's "20th Annual Report of Biopharmaceutical Manufacturing and Production" show that lasting sustainability strategies should focus on profitability aspects. That's because, even more than a spirit of stewardship, financial advantages provide a powerful incentive to stick to the plan.
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How To Prepare For An FDA Inspection
7/29/2019
An FDA inspection is very different than an ISO certification or surveillance audit — too often, organizations “prepare” for scheduled ISO audits by playing catch-up on activities that have been neglected or otherwise overlooked. The catch-up strategy will be problematic for FDA inspections.
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Welcoming The “Era Of ADCs”
12/5/2023
Dr. Loretta Itri sat down to explore the promise of TRODELVY®️ and other antibody-drug conjugates as transformative treatments for a range of malignancies and intractable diseases.
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What You Should Expect From A High-Functioning CDMO
5/18/2023
In part one of a two-part series, the authors detail whether to make or buy and how to work effectively with a CDMO.