FEATURE ARTICLES
Regulatory changes, space/footprint constraints and expanding automation garnered more votes than the other challenges. Let’s explore these challenges, and see how the industry is tackling them as we move into 2026.
- The 5-Layer Fix For AI Failure In Pharmaceutical Manufacturing
- Why Use Total Organic Carbon Analysis For Cleaning Validation?
- December 2025 — CDMO Opportunities And Threats Report
- 5 FDA Approval Categories In 2025
- A 2025 Pharma Look Back and Look Forward: Editor Style
- 2026 CDMO Forecast: The 7 Shifts Sponsors Need To Prepare For
- A Deeper Look At Pharma's Structural Supply Chain Vulnerability
PHARMA ONLINE WHITE PAPERS
-
![GettyImages-1382353763-hand-bubble-co2-green]( "Bio-Based Polymers Towards Net Zero In Single-Use Bioprocessing")
Bio-Based Polymers Towards Net Zero In Single-Use BioprocessingDecarbonizing healthcare and pharmaceuticals is vital to meet climate goals and safeguard public health. Learn why these energy-intensive sectors must act swiftly to reduce emissions and navigate complex global supply chains.
-
White Paper: Nasal Delivery Of Spray Dried Biologics: Opportunities And Challenges10/16/2024
Explore the potential of spray-dried nasal formulations for biologics to achieve excellent stability and targeted delivery, paving the way for innovative and effective therapeutic solutions.
-
Advances In Regulations For Viable Environmental Monitoring2/21/2025
Viable air monitoring is critical for environmental monitoring programs in pharmaceutical manufacturing. Explore current regulatory standards as well as the impact of the EU GMP Annex 1 revisions.
-
EMA Support For Rare Disease Therapies6/10/2025
Review how the EMA supports rare disease drug development through regulatory and financial incentives for therapies that meet strict eligibility and ongoing compliance criteria.
-
Viral Disinfectant Efficacy Studies: Key Guiding Factors And Design Elements4/8/2025
Achieving compliance and safety through Disinfectant Efficacy Studies (DES) is about adhering to regulations and committing to high standards of safety and quality of manufacturing operations.
-
The GxP Digital Maturity Model8/8/2025
Explore how the GMP Digital Maturity Model guides life sciences companies through five stages to improve compliance, efficiency, and profitability with strategic digital adoption.
PHARMA ONLINE APP NOTES & CASE STUDIES
- Multiple Fill Line Delivery Experience
- HPLC Analysis Of Ashwagandha Supplements Using Alliance™ iS HPLC System
- Filling Syringes With Spray-Dried Powders - The How, The Why And The Benefits
- Bend Successfully Rescues Powder-Filled Capsule Program
- Replicating An HPLC Method For Water-Soluble Vitamins: Part 1
NEWSLETTER ARCHIVE
- 02.06.26 -- Biological Indicator Testing – Meeting Regulatory Demands With Confidence
- 02.05.26 -- STREAM Edition: Contamination Control Strategies For Drug Manufacturers
- 02.03.26 -- Novo's Path To The First GLP-1 Weight Loss Pill
- 02.03.26 -- Composable MES For Pharma
- 02.01.26 -- 5 FDA Approval Categories In 2025
INDUSTRY NEWS
-
![FDA Logo on phone screen-GettyImages-2208861549]( "Høeg In, Pazdur Out At The FDA")
Høeg In, Pazdur Out At The FDAWhat an eventful week it has been at the FDA, with Richard Pazdur, M.D., resigning after weeks in his position as director of Center for Drug Research and Evaluation (CDER), and his vacancy being quickly filled by acting director Tracy Beth Høeg, M.D.
-
![business peope negotiating-GettyImages-637902194]( "9 Drugs Granted Fast Track By FDA's Voucher Program")
9 Drugs Granted Fast Track By FDA's Voucher ProgramWith targets like pancreatic cancer, deafness, blindness, infertility and vaping addiction, these drugs were chosen due to an unmet need, addressing a public health crisis, boosting domestic manufacturing or increasing affordability.
-
![Pharmaceutical sorting machine, pills-GettyImages-1499814881]( "Leaders In The Excipient Market: Region And Type")
Leaders In The Excipient Market: Region And TypeThough North America led the market with a 38.32% market share of $3.15 billion in 2024, Asia Pacific is expected to have the fastest growth in the upcoming years.
-
![GettyImages-2189405678-GLP-1-obesity]( "Pfizer Strengthens Obesity Foothold With Metsera Acquisition")
Pfizer Strengthens Obesity Foothold With Metsera AcquisitionAfter discouraging efforts to bring two oral obesity drugs to market—danuglipron and lotiglipron—this acquisition launches Pfizer back into the obesity therapeutic game.
-
![weight loss, diabetes, insulin pen-GettyImages-2196049931]( "FDA Cracks Down On GLP-1 Imports")
FDA Cracks Down On GLP-1 ImportsGLP-1 bulk drug substances must be detained without physical examination (DWPE) unless they are on a list (Green List) of approved foreign GLP-1 manufacturers.
PHARMACEUTICAL ONLINE CONTENT COLLECTIONS
Explore how sterility assurance, including sterilization validation and environmental monitoring, is essential for controlling microbial contamination in mammalian cell production to ensure patient safety. Check out the latest e-book from Pharmaceutical Online.
More Content CollectionsSUPPLIER NEWS
-
Is A Cybersecurity Boom On The Horizon? KPMG Survey Shows Surge In Cybersecurity Investment As AI Threats Redefine Risk2/5/2026
A cybersecurity boom appears imminent as businesses invest to defend against a new generation of sophisticated, AI-driven threats. According to the 2025 KPMG Cybersecurity Survey, a staggering 99% of security leaders plan to increase their cybersecurity budgets over the next two to three years, signaling that cybersecurity is no longer just a priority but a critical business imperative.
-
Eli Lilly To Build New $3.5B Injectable Drug Manufacturing Site Supporting GLP-1 Therapies In Pennsylvania2/2/2026
Eli Lilly and Company (NYSE: LLY) today announced plans to invest more than $3.5 billion in a new manufacturing facility in the Lehigh Valley, Pennsylvania.
-
Halo Pharma To Become A Stand-Alone Drug Product Contract Development And Manufacturing Organization (CDMO)1/27/2026
Halo Pharma, a leading CDMO specializing in drug product pharmaceutical development and manufacturing services, will become a stand-alone business as a result of the sale of the Noramco API and associated businesses to Siegfried.
-
Eurofins CDMO Alphora Announces Development & Implementation Of AI-Powered Salt And Co-Crystal Screening Software1/26/2026
Developed by Eurofins CDMO Alphora, in collaboration with a local university, this cutting-edge machine learning platform provides highly accurate predictions of salt and co-crystal formation for APIs and intermediates.
