FEATURED EDITORIAL
Continuous processing adoption so far has been slow; however, market research shows demand and capacity will grow significantly over the next four years.
- Quick Takes From Takeda Austria’s Annex 1 Rollout
- Navigating Grades And Sources Of Materials In Drug Manufacturing
- Fine-tuning Analytical Development Strategies For Every Phase
- A Guide To Proactive Supplier Management In The Pharma/Biotech Industry
- How To Measure Cell Density In Real Time With Soft Sensors
- Process Development With “The End In Mind” For Startups
- Considerations For Robust Implementation Of The Multi-Attribute Method
GUEST COLUMNISTS
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Navigating Grades And Sources Of Materials In Drug Manufacturing
From raw materials to finished dosage forms, understanding material quality is essential in drug manufacturing. This article examines how material grades and sources guide selection for optimal safety and functionality.
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Fine-tuning Analytical Development Strategies For Every Phase
Analytical challenges morph phase-by-phase during drug development. Three Novartis scientists describe a platform approach based on guidance from the ICH and USP.
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A Guide To Proactive Supplier Management In The Pharma/Biotech Industry
Proactively mitigate supply disruptions with strategic supplier selection and diversification, effective communication, risk management, quality assurance, and more.
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How To Measure Cell Density In Real Time With Soft Sensors
Soft sensors can enable real-time monitoring of key process variables, including viable cell density. Here's how one team at Takeda put them to use.
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Process Development With “The End In Mind” For Startups
We encounter the term “the end in mind” in product development frequently, but many are unsure what it really means and when it matters. This article sheds light.
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Considerations For Robust Implementation Of The Multi-Attribute Method
USP experts explore implementation strategies for the multi-attribute method, including best practices summarized from the USP’s General Chapter <1060>.
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2024 LIMS Trends
The laboratory information management system (LIMS) landscape in 2024 is a dynamic one, driven by accelerating advancements in technology and evolving industry needs. This article shares the four key trends.
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A New Model Approach To Drug Shortage Prevention
The ISPE's Drug Shortages Prevention Model revamps its predecessor, the more prescriptive Drug Shortages Prevention Plan, with a focus on 12 key performance areas.
PHARMA OUTSOURCING WHITE PAPERS
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Navigating The Regulatory Maze: Fundamentals For Drug Development
Learn about key regulatory concepts and ways to accelerate and reduce risk throughout the drug development journey.
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Nasal Vaccine Development, Manufacturing, And Device Selection
When developing a nasal delivery program, a partner with experience in development and manufacturing techniques who can see a program through small-scale clinical to commercial supply is crucial.
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A Comparative Analysis Of Mixing Characterization Methods
In the bioprocessing industry, there is no single, standard method for measuring mixing performance. Here, we investigate the four most widely used methods for measuring mixing time.
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Placing Drug Strategies On A Solid Foundation For Success
Explore how certain drivers are impacting traditional drug development strategies and relationships with outsourced drug development and manufacturing partners.
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A Scalable Single-Use Two-Step pDNA Purification Process
Evaluate the performance of a single-use two-step plasmid purification process, and see how it compares to the existing three-step purification method.
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The Role Of The Technical Transfer Executive Sponsor
Explore the importance of understanding a CDMO’s flexibility and culture, models and scale of equipment, technical capabilities, regulatory support, quality system, and executive sponsorship model.
PHARMA OUTSOURCING APP NOTES & CASE STUDIES
- CDMO Supports Complex Bispecific Antibody Development
- Chromatography Solutions For AAV Full And Empty Capsid Separation
- Reducing The Level Of Host Cell Proteins In The Bioreactor Harvest
- Impact Of Glycosylation On The Effector Functions Of Monoclonal Antibodies
- Recombinant Protein Purification Optimization With HIC
NEWSLETTER ARCHIVE
- 03.29.24 -- Outsourcing Nirvana At Eli Lilly
- 03.28.24 -- Optimizing CGT Development: Modular Approaches And Cryopreservation Insights
- 03.28.24 -- Developing Cell & Gene Therapies: Optimization-By-Design, Analytical Ultracentrifugation, Candidate Screening, And Feasibility Studies
- 03.28.24 -- Creating T Cell Vaccines In The Sands
CONTENT COLLECTIONS
They say biotech taught pharma how to outsource. So what’s someone who has spent 31 years working in Big Pharma know about outsourcing from the vantage point of smaller organizations? A lot, it turns out. In this latest e-book, Chief Editor, Louis Garguilo sits down with Francis Dumont just after he retired from Pfizer for an in-depth conversation on drug development and manufacturing outsourcing.
More Content CollectionsPRODUCTS & SERVICES
ON-DEMAND WEBINARS
- The Increasing Demand For Sterile Filtration Of High Concentration Drugs
- Enhancing Quality By Employing Cell Line Replacement, Process Optimization
- Why KinetiSol® Is Disrupting Spray Drying
- KinetiSol® Technology: Scale Up Approach
- Identify And Quantify AAV Fill States Using Analytical Ultracentrifugation