FEATURE ARTICLES
Revisions to ICH Q14 remedied some shortcomings, but the latest version still contains errors and ambiguities. Here is a detailed breakdown.
- Cleaning Process Capability: Risk-Based Cleaning Process Performance Qualification
- Understanding FDA's New National Priority Voucher Pilot Program
- AI-Assisted QMS: Bridging ISO/IEC 42001:2023 And ICH Q10 For Pharmaceutical Excellence
- Navigating FDA Regulatory Changes: Policy Shifts, Deregulation, Restructuring, And Future Oversight
- Understanding FDA's Draft Guidance: Composition Statements Of Ingredients In Labeling In NDAs And ANDAs
- How Is RIM Software Transforming Regulatory Compliance?
- Formulation Development Of A JAK1 Inhibitor Extended-Release Tablet
PHARMA ONLINE WHITE PAPERS
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![GettyImages-1474595785 AI]( "AI Implementation To Enhance Quality")
AI Implementation To Enhance QualityDiscover how solutions driven by artificial intelligence can enhance compliance, optimize workflows, and drive efficiency in biopharma operations.
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Challenges In Developing Medical Devices From Animal-Based Biomaterials In China11/11/2024
Bovine collagen, valued for biocompatibility and versatility, is gaining attention for medical devices in China as regulatory barriers ease, though safety assurances remain crucial.
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Could RFID-Based Unit-Level Traceability Be Key To Operational Excellence?9/5/2023
Radiofrequency identification (RFID)-based unit-level tracking solutions for prefilled syringes are poised to help pharma manufacturers address key risks and costly bottlenecks related to the fill-finish process.
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2024 Global Biopharma Sustainability Review9/3/2024
What steps is the biopharma industry taking to enhance sustainability? What challenges does biopharma encounter? And how can the entire industry draw lessons from the companies setting the standard?
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Finding An Optimal Harvest Solution By Considering Cost And Sustainability7/10/2024
Choosing the right harvest solution is pivotal in the pursuit of efficient and sustainable bioproduction. Explore the benefits of a single-use centrifuge over traditional depth filtration methods.
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Modern Modeling Tools For Small Molecule Solid Dose Manufacturing3/10/2025
Data-driven modeling techniques can enhance scale-up processes, streamline production, and help companies navigate the complexities of modern drug development with greater precision and reliability.
PHARMA ONLINE APP NOTES & CASE STUDIES
- How A Pharma Company Improved Yield By 1.5% In Just Three Months
- N-1 Perfusion High Inoculum Fed-Batch For Reduced COGS And Easy Retrofit
- Deploying A Modern HPLC For Biopharma Analysis In QC Environments
- Navigating Regulatory Compliance: A Success Story In The Pharma Industry
- Thermal Analysis In The Pharmaceutical Industry
NEWSLETTER ARCHIVE
- 07.03.25 -- STREAM Edition: Solid Phase Versus Liquid Phase Peptide Synthesis
- 06.28.25 -- Product Inspection And Packaging Solutions For Pharma
- 06.27.25 -- ADCs Unleashed: Navigating Development Hurdles In Targeted Cancer Therapy
- 06.26.25 -- The 3 Phases Of QRM – An Inspector's View
- 06.26.25 -- STREAM Edition: Improving Peptide Yields Upstream
INDUSTRY NEWS
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![White Tablets-GettyImages-172969989]( "Researchers Switch Up Paracetamol Production With Eco Method")
Researchers Switch Up Paracetamol Production With Eco MethodScientists at the University of Edinburgh’s Wallace Lab developed a method to produce paracetamol that can reduce environmental pollution and the industry’s reliance on fossil fuels
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![FDA Approved stamp-GettyImages-2196512628]( "FDA Addresses U.S. Health Crisis With Voucher Program")
FDA Addresses U.S. Health Crisis With Voucher ProgramFDA Commissioner Marty Makary, M.D., M.P.H., tapped into his oncologist experience to launch a new FDA program designed to fast-track the time it takes for important drugs to receive approval and get to patients.
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![Scientists working in lab-GettyImages-542935478]( "Lab Oversupply Is Pushing Leasing, Rent and Relocation Down")
Lab Oversupply Is Pushing Leasing, Rent and Relocation DownThe landscape of the U.S. pharmaceutical lab market is changing, according to JLL’s U.S. Life Sciences Property Report. In addition to the effort to bring pharma manufacturing back to the U.S. ahead of looming tariffs, an oversupply of space and lower tenant demand in large biopharma markets is dropping leasing rates, rent costs and lease duration, among other changes.
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![US Food and Drug-GettyImages-2200850893]( "CDER's Director Set To Retire Amid FDA Leadership Shuffle")
CDER's Director Set To Retire Amid FDA Leadership ShuffleJacqueline Corrigan-Curay, M.D., J.D., announced plans to retire from her position as acting director of CDER, calling the decision "incredibly challenging." Corrigan-Curay is not alone in her decision to leave the FDA, with a number of leaders exiting the agency since January.
PHARMACEUTICAL ONLINE CONTENT COLLECTIONS
The modern microbiology laboratory is starting to look very different from the laboratory of even 10 years ago. The work will be similar, yet technology will have advanced. Automation, in particular, is taking center stage. Check out the latest e-book from Pharmaceutical Online.
More Content CollectionsSUPPLIER NEWS
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Axplora To Double Its Manufacturing Capacity In Italy With Expansion7/7/2025
Axplora is proud to unveil a transformative €35 million expansion at its Farmabios site in Gropello Cairoli, Italy, reinforcing the company’s longstanding commitment to serving the evolving needs of its customers through strategic investment and innovation. This latest investment builds on the €45 million already committed over the past five years, bringing Axplora’s total recent investment in Farmabios to over €80 million.
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Packaging And Process Equipment Auction Announced7/7/2025
Are you looking to upgrade your packaging line or start a new one without breaking the bank? Don’t miss the Proxio Group – “Processing & Packaging Equipment for Multiple Industrial Applications” auction hosted on BidSpotter, with lots closing July 23, 2025, at 10:30 am ET in Cleveland, OH.
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CDMO BioSpring To Build New API Manufacturing Facility In Germany7/3/2025
Groundbreaking for the future: Together with Hesse’s Minister President Boris Rhein (CDU) and the Mayor of Offenbach, Dr. Felix Schwenke (SPD), BioSpring today inaugurated a new chapter in its company history on the Offenbach Innovation Campus. The company is building a new production facility that will set new standards and, once completed, become one of the world’s largest production sites for DNA- and RNA-based active pharmaceutical ingredients (APIs). This positions BioSpring as a key economic driver in Hesse and in one of the fastest-growing segments of the biotech industry.
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InQuest Science Seeking Business Development Executive To Promote Software Technologies7/3/2025
Actively looking for an energetic, self starter to lead our outside sales team for our software company, specializing in the visual inspection industry. Identifying and securing new customers leads in a growing industry. We’re looking for a results-driven sales representative to actively seek out and engage customer prospects.
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Riverarch Equity Partners Announce Acquisition Of Alconox By Portfolio Company TCP Analytical7/3/2025
Riverarch Equity Partners (“Riverarch”) and other investors, including Audax Strategic Capital, The Hillman Company, Lacy Diversified, and PPM America, together with their portfolio company TCP Analytical are pleased to announce the acquisition of Alconox, LLC (“Alconox” or the “Company”), a leading provider of branded laboratory cleaning solutions.
