Roche has pushed through so-called "pilot purgatory" and rolled out artificial intelligence solutions in the real world. Two of its data leaders describe three case studies.
- Computer Systems Validation Pitfalls, Part 1: Methodology Violations
- Sterility Assurance: The Fundamentals
- Expert Voices: Why Aren't QC Labs Fully Automated Yet?
- What To Do When Your Regulatory Findings Need Quality Risk Management Action
- 5 Strategic Advantages Of Manufacturing ADCs In-house
- Outsourced Complex Protein Development Demands Special Considerations
- Accelerate CMC Development With Team Topologies
GUEST COLUMNISTS
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Computer Systems Validation Pitfalls, Part 1: Methodology Violations
When computer systems validation work is not performed according to protocol instructions — by cutting corners on quality outputs with the focus on profit as the main driver — this can result in drug and device companies losing profits and efficiencies.
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Sterility Assurance: The Fundamentals
Sterility assurance is a critical aspect of the production of drugs and medical devices. This article covers the fundamentals, including the key components of an effective sterility assurance program.
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Expert Voices: Why Aren't QC Labs Fully Automated Yet?
Leading automation experts chime in on why QC labs, otherwise ideal for robotics, have been slow to adopt and standardize the technology.
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What To Do When Your Regulatory Findings Need Quality Risk Management Action
More than half of all recent warning letters issued by the FDA include citations for absent or incomplete risk assessments. This article examines what regulators are looking for.
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5 Strategic Advantages Of Manufacturing ADCs In-house
Outsourcing antibody-drug conjugate manufacturing is the status quo. This executive explains why her company chooses to do it themselves for reasons including quality control and cost management.
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Accelerate CMC Development With Team Topologies
A method of defining role boundaries for knowledge workers in the IT industry maps nicely to CMC process development for biologics and pharmaceutical manufacturing.
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Upping Flow Of Advanced Technologies Into Commercial Biomanufacturing
A set of tools NASA developed assessing new, rapidly developed and deployed technology could help biopharmas adopt advanced tech post-commercialization.
BIOSIMILAR WHITE PAPERS
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Optimizing Safety Measures For rAAV Therapies
Explore common process-related impurities found in recombinant Adeno-Associated Virus (rAAV) vectors and the analytical testing methods used for these residuals.
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The Advantages Of A Blended Learning Approach In Operator Training5/30/2024
Explore blended learning and its advantages over traditional operator training methods, which often reduce training to a repetitive but necessary checklist of reading and acknowledging procedures.
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Impact Of Immunogenicity On Efficacy And Safety Of Biosimilars2/9/2024
The presence of ADAs can affect the effectiveness and safety of biologic drugs. Read why regulatory agencies emphasize the need for extensive immunogenicity evaluation in biosimilar development.
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Establishing Analytical Methods For mRNA-Based Therapies6/13/2023
Here, we provide a detailed description of assays for sequence identification and LNP composition in mRNA-LNP products that support the development of safe and effective mRNA therapies.
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The Evolution Of Antibody-Drug Manufacturing6/3/2024
Explore how ADC chemistry and manufacturing have evolved, the challenges this dynamic growth has created, and how CDMOs are adapting to these changes to meet customer needs, now and in the future.
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Inspection Of Injectable Products For Visible Particulates8/8/2023
Examine the risks posed by particulates, the potential sources and types of particulates, and approaches to detect and measure visible particulates in injectables.
BIOSIMILAR APP NOTES & CASE STUDIES
- Developing A Large-Scale Tangential Flow Filtration Process
- Impact Of DMSO And Freezing Technique In Upstream Bioprocessing
- Media And Buffer Mixing Using The Xcellerex™ Magnetic Mixer
- Exosome Isolation By TFF And Size Exclusion Chromatography
- Accelerating Bulk Harvest Testing Using A CHO Animal Origin Free Virus Panel
BIOSIMILAR DEVELOPMENT CONTENT COLLECTIONS
The debate over whether the biosimilar regulatory paradigm can shift away from comparative efficacy trials has intensified over the past few years. This collection of articles serves as a snapshot of the many different components of this ongoing discussion.
More Content CollectionsBIOSIMILAR DEVELOPMENT NEWS
- Bio-Thera And Richter Execute Exclusive Commercialization Agreement For BAT2206, A Proposed Stelara® Biosimilar, For EU countries, UK, Switzerland And Other Selected Countries
- Biocon Biologics' Commissioned Report Highlights Pathways To Increase Adoption Of Biosimilars In LMICs
- Teva Prolia® (Denosumab) Biosimilar Candidate Is Accepted For Review By U.S. FDA And EU EMA
- Prime Therapeutics Announces New, Cost-Effective Humira® Biosimilar Solutions, Offering Clients Flexibility And Choice
- Teva And mAbxience Expand Strategic Partnership To Include An Additional Oncology Biosimilar Candidate
- Blue Shield Of California Slashes Cost Of World's Best-Selling Drug
- Evio Announces Groundbreaking Direct Purchase Agreement For Adalimumab Biosimilar
- Fresenius Kabi And Formycon Receive U.S. FDA Approval For Biosimilar Otulfi* (ustekinumab-aauz)
NEWSLETTER ARCHIVE
- 10.10.24 -- Tips For Addressing Vaccine Demand – No Matter Your Therapeutic Background
- 10.10.24 -- Upping Flow of Advanced Technologies Into Commercial Manufacturing
- 10.03.24 -- The Peril Of Analytical Method Transfer
- 10.02.24 -- Dig Into Ideas, Data, And Examples Of Bioprocessing Intensification Strategies
- 10.01.24 -- Unlocking Biomanufacturing Success: Partnerships, Immunogenicity, And Tech