Industry Insights
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Virtual Patient Registries: Real-World Evidence For Cell And Gene Therapies
5/31/2019
In recent years, cell and gene therapies have been generating highly promising results in clinical studies, advancing them toward the market. However, the small number of products launched to date have not been proven commercial successes, with a number of advanced therapies being withdrawn from the EU market and limited sales of CAR-T therapies in the U.S.
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Biosimilars Paving The Way For Cost-Effective Bioprocessing
8/23/2017
As biosimilars finally move into mainstream commerce in the world’s major (bio)pharmaceutical markets, they are bringing with them some side benefits. Sponsors frequently focus resources on production technologies that generate higher productivity and yields. Some of these cutting-edge technologies are applicable to mainstream pipeline biologics, so future biopharmaceuticals will benefit from this push for efficiency.
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4 Key Usability Considerations For Biopharmaceutical Delivery Device Design
7/9/2019
Often, the last thing on the minds of drug development teams working is the human factors engineering (HFE) performance of the drug delivery devices that will ultimately deliver their innovative medications to patients. Yet, such an oversight can cause major delays in delivering these new medications to market.
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Best Practices For Cell Culture Media Fingerprinting
3/13/2023
This three-tier approach to cell culture media fingerprinting helps you to define an alternative method that will allow verification of the quality of the medium as well as fingerprinting. It helps you to choose suitable methods for incoming ID testing based on raw material properties, goals of media characterization, and the resources available.
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CAPA System Best Practices For GMP Compliance
7/25/2022
A CAPA system should be understood as an important element of the pharmaceutical quality system and implemented uniformly throughout the company or group. This article delves into the pros and cons of autonomous and integrated systems, and shares some overall CAPA best practices.
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Moving Your QMS Beyond (Current And Future) Regulatory Expectations: A 7-Step Process
12/27/2018
Currently, sponsors running clinical trials have established quality management system (QMS) frameworks inclusive of organizational structure, processes, and procedures on the following premise: The QMS helps maintain a company’s compliance to regulations, ultimately with the hopes of ensuring patient safety, product quality, clinical responsibility, and data integrity.
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4 Important Things To Consider Before Developing A Drug Delivery Device
8/6/2019
This is Part 1 of a two-part article discussing important areas to consider when developing devices for combination products — and why they need to be addressed early in development. In this installment, we will look at the areas of primary container, device development, device selection, and design control.
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How Client Input Shaped A Production Facility Expansion
10/19/2023
In addition to streamlining processes and implementing new technologies, new facility design provides tremendous opportunity to positively impact client timelines, costs, and options for flexibility.
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Are "Do-Overs" Practical In Biopharmaceutical Manufacturing?
4/28/2017
What should a manufacturer do when an API or intermediate from a biopharma manufacturing process does not meet specification, or when a process has operated outside the validated operating range?
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3 Strategies For Optimal Oversight Of Your Outsourcing Partner
7/20/2022
Building strong relationships with CDMOs and CROs relies on a solid outsourcing framework. Review three key areas that should be built into your outsourcing framework and agreements.