Industry Insights
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Alliances at the margins: Board out of your mind
1/23/2001
The deal is signed, now it's time to make it work...
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Accelerate And De-Risk Bioconjugate Drug Development
With a growing interest in developing new and improved bioconjugate drugs, explore an “innovation through collaboration” approach that can facilitate access to next-generation conjugation technologies.
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American-Made, Worldwide Benefit: Raising The Bar In Isolated Fill-Finish Manufacturing
3/18/2024
Learn about the development process behind a new, state-of-the-art fill-finish isolator that's addressing issues in isolator manufacturing and servicing, as well as meeting the needs of the liquid pharmaceutical market.
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Design–Build Cleanroom Projects: A Proven Risk Mitigating Methodology
11/17/2023
Learn about the rising demand for cleanrooms in the biopharmaceutical industry, factors driving cleanroom design, building in flexibility, the role of critical path assessments, and more.
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Assessing The Impact Of COVID-19 On Regulatory Interactions, Inspections, & Audits
3/19/2020
While we have not seen any significant delays in regulatory approval of life science products to date, the impact of COVID-19 on regulatory interactions, inspections, audits, and global health authorities is continuing to evolve.
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QbD Validation Strategies: The Process Design Phase Part 1
2/5/2013
Process validation comprises three stages that take place over the life cycle of the pharmaceutical drug product. (See Figure 1.) Stage 1, which will be the focus of this column, is referred to as process design, and encompasses pharmaceutical drug products in early development. Stage 2 is referred to as process qualifications, and includes pharmaceutical drug products at a stage prior to commercialization or prior to submitting a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Stage 3 is referred to as continued process verification and includes pharmaceutical drug products that are commercialized and currently marketed products with completed prospective validation. Products that fall in between these categories will need to be assessed on a case-by-case basis and can be placed in the appropriate stage using a "gateway" approach. By Anil Doshi, R.Ph., Ph.D, President, Infinity Pharmaceutical Consulting
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Model-Based Control In Continuous Manufacturing of Biotherapeutics
11/10/2021
During continuous processing, automated control techniques coupled with process analytical tools are required to monitor critical quality attributes and implement real-time control decisions to handle deviations. This article is the first in a two-part series examining how model-based control can be effectively implemented in the various unit operations.
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Biosimilars Pipeline Analysis: Many Products, More Competition Coming
7/26/2016
Our discussion of biosimilars in this article will center on developed-market GMP biosimilars. In the European market alone, biosimilars already are a multibillion-dollar business, and one that is rapidly growing.
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What Management Skills Have The Most Impact On GMP Performance?
2/12/2015
Some think the most critical success element in a GMP environment is the technical knowledge of those who perform the tasks, lead, or make decisions. For those in leadership or management roles, it is important to possess technical strength, but there are additional skills they must also have in order to truly be successful. So what specific skills do managers and supervisors need to be successful in a GMP environment?
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Powder Characterization For Process Designers And Engineers
12/29/2009
For process designers specifying new plant, the goal is to engineer equipment that will process and handle powders consistently and efficiently, as defined by the design brief. In contrast, engineers working as part of the manufacturing team rarely have the option of changing out equipment, but strive to achieve acceptable operation using the existing plant. While these goals are somewhat different the two groups share a need for detailed process understanding, knowledge of the interplay between powder properties and process equipment and how, in combination, they deliver product with the intended properties and quality. By Tim Freeman, Freeman Technology