FEATURE ARTICLES
A forthcoming ISPE guide uses case studies to aid in the design of plug-and-play process skids with implications for every step in the manufacturing process continuum.
- Fostering A Quality Software Culture
- Lessons In Quality From Sanofi's Plai.qa
- Hidden Sensitive Data Liability: Why Legacy Web Forms Put Life Sciences Organizations At Critical Risk
- Here's What You Need To Know About The Access Consortium Pathway
- Is Charisma An API?
- Maximizing The Value Of An Internal Audit Program In Pharmaceutical Quality Operations
- 3 Ways To Deliver A Pharma 4.0 Facility
PHARMA ONLINE WHITE PAPERS
-
![GettyImages-1309776504-viral-inspection-laboratory-scientists]( "Next Generation Sequencing In Viral Safety Testing")
Next Generation Sequencing In Viral Safety TestingNext Generation Sequencing (NGS) offers a sensitive, high-throughput solution for detecting adventitious viral agents (AVAs), improving biopharmaceutical safety and accelerating regulatory-compliant product development.
-
Seasonal Vaccine Manufacturing: 3 Areas To Evaluate When Selecting A Partner10/16/2024
Experienced outsourcing partners will have the right facility and technical capabilities, a culture of speed and execution, and shared expectations and commitment to continuous improvement.
-
Optimizing DSP Development: Faster Timelines, Lower Costs, And High-Quality Processes4/8/2025
The biopharmaceutical industry faces growing downstream processing challenges in purifying complex biologics efficiently and at scale.
-
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.
-
GMP Compliance For Pharmaceuticals And Medical Devices3/14/2025
Good Manufacturing Practice (GMP) ensures products meet quality standards for their intended use, which covers all aspects of production. Explore how Ideagen supports GMP compliance across nine titles.
-
A Risk-Based Approach To Plasmid DNA And mRNA Process Development9/23/2025
Balancing robust analytics and clinical readiness is key for early-phase pDNA and mRNA therapeutics amid structural complexity and regulatory challenges.
PHARMA ONLINE APP NOTES & CASE STUDIES
NEWSLETTER ARCHIVE
- 12.11.25 -- Simplify Your ADC Development And Manufacturing Journey
- 12.11.25 -- Innovation, Growth (And Happiness) Projected For Pharma
- 12.11.25 -- STREAM Edition: Answering The Demand And Innovation
- 12.10.25 -- Unlock New Delivery Routes: The Nanoforming Revolution
- 12.09.25 -- New Technical Insights To Elevate Your CDO Programs
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
-
$6B Commitment: Eli Lilly Expands U.S. Manufacturing With New Huntsville Facility12/10/2025
Eli Lilly and Company (NYSE: LLY) today announced plans to invest more than $6 billion in a new manufacturing facility in Huntsville, Alabama. This next-generation synthetic medicine active pharmaceutical ingredient (API) facility, the third of four new U.S. sites Lilly plans to announce, will produce small molecule synthetic and peptide medicines.
-
Bora Pharmaceuticals And Corealis Pharma Forge Strategic Alliance To Deliver Seamless, End-To-End Oral Solid Dose Development12/9/2025
Bora Pharmaceuticals Co., Ltd. (“Bora”, TWSE: 6472), a global leader in pharmaceutical manufacturing, and Corealis Pharma Inc., a leading early-phase Contract Development Manufacturing Organization (CDMO), have entered into a strategic alliance to provide end-to-end services for oral solid dose (OSD) development and manufacturing. The collaboration will simplify the drug development process and provide a more scalable pathway to commercialization via a single continuum.
-
Marchesini Group And AST Unite To Expand Global Sterile Fill-Finish Capabilities12/9/2025
Marchesini Group, a leader in pharmaceutical packaging machinery, and AST, a U.S leader in the drug product manufacturing industry, have entered a strategic partnership that combines the expertise, technologies, and global reach of two highly respected industry leaders.
-
Bora Pharmaceuticals Marks Five Years In Mississauga, Canada, Strengthening Its Commitment To Onshore And Global CDMO Excellence12/5/2025
Bora Pharmaceuticals Co., Ltd. (“Bora” or “the Company”, TWSE: 6472), a global leader in pharmaceutical manufacturing, today celebrates the five-year anniversary of its Mississauga, Ontario, Canada facility, a key hub in the company’s North American operations and a cornerstone of its expanding international CDMO network. The milestone will be celebrated onsite with employees, partners, and community stakeholders.
