FEATURE ARTICLES
Learn what regulators are already asking about AI, what quality must mean in this new context, and how organizations can begin building the governance infrastructure.
- 4 Facility Considerations for API Manufacturing
- Ever Wonder What Running A $50B Capital Facilities Project Feels Like?
- Generative AI Can Write The Code, But Who Builds In The Quality?
- February 2026 — CDMO Opportunities And Threats Report
- FDA's Final NDC Rule Provides A 900-Year Supply Of Label Codes
- Clearing The Fog On New First Air Visualization Expectations
- FDA's 483 Playbook: What It Means For Pharma Outsourcing — And What It Doesn't Address
PHARMA ONLINE WHITE PAPERS
-
![cdmo-next-gen-manufacturing-GettyImages-1938554520]( "Building the Next Generation of TIDES Manufacturing Excellence")
Building the Next Generation of TIDES Manufacturing ExcellenceRising demand for complex TIDES therapies is shifting manufacturing expectations, driving adoption of continuous processing, digital tools, stronger supply strategies, and greener, scalable synthesis.
-
From Open Cleanrooms To Closed Systems – What Is Driving The Change?3/14/2025
Aseptic processing is evolving. Regulatory changes and technological advancements are driving a shift from open cleanrooms to closed systems for sterile drug manufacturing.
-
Extended Head Flats Increase Dwell Time4/25/2024
Explore the extended head flat and how this punch modification can improve the compression of difficult formulations.
-
Leveraging 3 Distinct Resins To Provide Effective Impurity Removal For mAbs And Novel Antibody Derivatives11/3/2025
Due to the complexity of bispecifics, Fc-fusion proteins, and Fab fragments, their manufacturing poses added purification challenges and requires a robust toolkit of purification techniques.
-
Advancing ADCs With Expertise In Payloads And Linkers2/18/2026
Discover how integrated containment, high-potency expertise, advanced chromatography, and proven linker–payload process optimization can accelerate your ADC program from early development to reliable commercial supply.
-
Facilitate Handling Of Bulk Powders With Dry Granulation8/11/2025
Handling bulk powders in manufacturing presents serious challenges—from unpredictable caking to safety risks—that can disrupt workflows. Discover solutions to streamline operations and protect your team.
PHARMA ONLINE APP NOTES & CASE STUDIES
- Simplifying Antibody-Drug Conjugate Payload Synthesis
- Fast And Accurate Detection Of Alzheimer's Disease Targets
- Why A Leading Manufacturing Partner Chose NeoTOP Packaging Machines
- Managing Risk In The Most Complex Combination Device Format
- Enhanced mAb Production With High-Intensity Perfusion CHO Medium
NEWSLETTER ARCHIVE
- 04.11.26 -- Pharmaceutical Online Best Of March
- 04.09.26 -- Clearing The Fog On New First Air Visualization Expectations
- 04.09.26 -- STREAM Edition: API Facility Considerations
- 04.08.26 -- Advancing Next-Generation Biologics: From Cell Line Innovation To Complex Modalities
- 04.07.26 -- Aseptic Insights & Automation
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
-
Symbiosis Expands Commercial Capabilities With Addition Of New Stability Chamber4/1/2026
Symbiosis Pharmaceutical Services (Symbiosis), a Contract Development and Manufacturing Organisation (CDMO) specialising in the sterile GMP manufacturer of injectable drug products, has expanded its Quality Control (QC) laboratory with the installation of a new 30°C stability chamber.
-
Eli Lilly's Foundayo™ Approved By FDA, Introducing A New Era Of Needle-Free GLP-1 Therapy4/1/2026
Foundayo, Lilly's second FDA-approved obesity medicine, will be available via LillyDirect® with free home delivery, starting at $25 per month with commercial coverage and $149 for self-pay
-
ROIS CDMO Closes On The Acquisition Of US Injectable Manufacturing Facility4/1/2026
ROIS, the CDMO arm of ROVI and a leader in injectable manufacturing, today announces closing the acquisition of a state-of-the-art injectable drug product manufacturing and packaging site in Phoenix, Arizona (USA) from Bristol Myers Squibb.
-
IMA Acquires Isolator Equipment Provider Prosys Sampling Systems Limited4/1/2026
The IMA Group strengthens its presence in aseptic and containment isolator technology. IMA has recently signed with ProSys Sampling Systems Limited an agreement that provides for the purchase of a majority of the company’s shares. Established in 1997, ProSys is a leading provider of Isolator and Sampling equipment to the global bio-pharmaceutical market.
