Improving microbiology laboratory efficiency is a continuum. Here are five tech-forward trends that will impact cost and efficiency in 2025.
- USP Chapter Covers Residual DNA Testing Practices For CHO And E. coli
- Are We Witnessing A New "Age Of The CDMO"?
- The 4 Technologies Poised To Transform The Pharmaceutical Supply Chain In 2025 And Beyond
- Computer Systems Validation Pitfalls, Part 3: Execution Inconsistencies
- Is The BIOSECURE Act The First Real Step Toward Reshoring?
- Defining When To Implement Technologies To Support Commercial Growth
- 3 Focus Areas To Transition From Clinical To Commercial Readiness
GUEST COLUMNISTS
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USP Chapter Covers Residual DNA Testing Practices For CHO And E. coli
Industry widely uses qPCR to measure residual DNA; however, the technique lacked a standard. USP's General Chapter <509> aims to remedy that.
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Are We Witnessing A New "Age Of The CDMO"?
Over the past few years, the pharma/biotech industry has seen a significant shift from internal to external manufacturing. This article examines the driving factors and the author's perspective for what to expect in 2025 and beyond.
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The 4 Technologies Poised To Transform The Pharmaceutical Supply Chain In 2025 And Beyond
These key technological advancements will significantly impact the pharma/biotech supply chain in 2025 and beyond. If you aren't implementing any of them yet, you may want to rethink your plans.
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Computer Systems Validation Pitfalls, Part 3: Execution Inconsistencies
The authors continue their article series on computer systems validation pitfalls by sharing a common mistake made by inexperienced senior QA personnel and more.
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Is The BIOSECURE Act The First Real Step Toward Reshoring?
The U.S. pharma industry has relied heavily on China and India to produce regulatory starting materials and APIs. The BIOSECURE Act has now emerged. Is this the first real step toward reshoring?
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Defining When To Implement Technologies To Support Commercial Growth
Technology decisions must be understood in the context of your business strategy and projected milestones. With a framework in place, you can define what tech solution you need and when you need it.
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3 Focus Areas To Transition From Clinical To Commercial Readiness
Transitioning from clinical-stage operations to commercial readiness is a multifaceted process. Establish compliant and robust distribution systems by focusing on these three areas.
BIOSIMILAR WHITE PAPERS
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How Can The Industry Drive Down The Cost Of Viral Gene Therapies?
This article discusses how a combination of optimizing your process development, and process intensification can help drive the cost of dose down.
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A Risk-Based Approach To Injectable Combination Product Development3/14/2023
Examine how to establish a holistic approach to drug-device combination product (DDCP) development and how to assess and manage risk throughout the development and approval process.
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Revolution In The EU Pharmaceutical Legislation Ahead2/8/2024
Discover the impact revised pharmaceutical legislation will have on the industry by superseding regulations that have fostered the availability of safe and effective medicines for the past two decades.
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Recommendations For Successful IND Approval Of RNA-LNP Drugs8/22/2023
The existing regulatory system is ambiguous for RNA therapeutics. Leverage this Investigational New Drug (IND) guide to help accelerate and strengthen the process IND filing of novel nanomedicines.
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A Supplier-Manufacturer Approach To Mitigating Nitrosamine Risk10/10/2024
Learn about how nitrosamines are formed, their prevalence and chemical precursors in pharmaceuticals, techniques for quantification, and approaches for managing nitrite impurities.
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Mycoplasma Contamination In Biopharmaceutical Manufacturing2/9/2024
Learn how strict laboratory practices and routine testing for mycoplasma contamination using nucleic acid-based assays can help ensure safe, high-quality biopharmaceutical products.
BIOSIMILAR APP NOTES & CASE STUDIES
- Characterization Of Host Cell Proteins By Liquid Chromatography - Mass Spectrometry
- Mobius® ADC Reactor Performance
- TFF Cassettes With 100 kDa Membranes For RNA And LNP Applications
- Developing A Large-Scale Tangential Flow Filtration Process
- Extractables In Single-Use Systems Used In ADC Manufacturing
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
- Accord BioPharma Announces Agreement By Intas Pharmaceuticals, Ltd. To Acquire UDENYCA® (pegfilgrastim-cbqv) Business From Coherus BioSciences, Inc., Unlocking Potential For Continued U.S. Growth
- U.S. FDA Approves Biocon Biologics' YESINTEK™, Bmab 1200 Biosimilar To J&J's Stelara® (Ustekinumab)
- First Shipment Of Henlius Trastuzumab To U.S.
- Boan Reached A Strategic Cooperation For Denosumab In Brazil
- Bio Usawa And Rwandan Government Sign A Memorandum Of Understanding To Manufacture Affordable Biologics In Africa
- Celltrion Announces The Acquisition Of iQone Healthcare Switzerland, Further Expanding Its Expertise And Presence In Europe
- Xbrane And Intas Enter Into A Global Licensing Agreement To Jointly Develop Nivolumab Biosimilar Referencing Opdivo
- Celltrion Presents Additional Data From Phase III Randomized Controlled Trials To Further Support Biosimilarity For CT-41 (Biosimilar Candidate Of denosumab) And CT-P47 (tocilizumab) At American College Of Rheumatology (ACR) Convergence 2024
NEWSLETTER ARCHIVE
- 12.05.24 -- Filter Integrity Testing Annex 1 Requirements For Biologics DS
- 11.27.24 -- A Comprehensive Guide For Supplier Quality Agreements
- 11.21.24 -- Tips For Addressing Vaccine Demand – Strategies For C&G And mRNA
- 11.21.24 -- Safety Cabinets' Essential Role In EU GMP Annex 1
- 11.14.24 -- Take The Next Step Towards Scaling-Up