FEATURE ARTICLES
MRAs can save resources for regulators and drug makers by, among other things, reducing the number of inspections and waiving retesting requirements.
- FDA Issues Final Guidance For pH Adjuster Waiver Requests For Generic Drugs
- Leveraging Historical Data to Accelerate Process Understanding
- 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?
PHARMA ONLINE WHITE PAPERS
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![GettyImages-931069642 mAb, monoclonal antibodies]( "Leveraging 3 Distinct Resins To Provide Effective Impurity Removal For mAbs And Novel Antibody Derivatives")
Leveraging 3 Distinct Resins To Provide Effective Impurity Removal For mAbs And Novel Antibody DerivativesDue 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.
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Establishing Commercial Manufacturing Services For ADCs6/3/2024
Explore how one organization built upon 15+ years of experience and an extensive knowledge base of biologics manufacturing to establish commercial-scale ADC manufacturing capabilities.
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Future-Proofing Life Sciences Manufacturing: 2025 CDMO Trends3/12/2025
Review contract manufacturing's evolution, driven by technological advancements and regulatory changes, and how CMOs and CDMOs are navigating opportunities and challenges.
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Overcoming Challenges To High-Concentration Formulation Development3/25/2025
Explore how the S-HiCon™ platform optimizes high-concentration therapeutic antibody formulations, overcoming stability and manufacturability challenges to deliver safe, effective therapies.
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Project Management: Sphere Of Influence10/21/2024
The project manager's sphere of influence extends beyond the project team, encompassing the organization, industry, and professional discipline.
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Normalized Data In Microbial Continuous Monitoring7/24/2025
Learn how EU GMP Annex 1 (2022) redefines cleanroom air monitoring standards and emphasizes continuous viable sampling in Grade A and B environments to ensure aseptic integrity and compliance.
PHARMA ONLINE APP NOTES & CASE STUDIES
- How Sharp Packaging's Clinical Packaging Process Is 30% Faster
- Support Digital Transformation And Enable Collaboration Between Teams
- AAV Empty/Full Ratio Assessment Using The Octet® AAVX Biosensors
- Automation-Assisted Washing Of Multicellular 3D Spheroids
- Characterization And Impurity Profiling Of Combined Amylin And GLP-1 Analogs
NEWSLETTER ARCHIVE
- 12.13.25 -- Pharmaceutical Online Best Of November
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- 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
INDUSTRY NEWS
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![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.
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![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.
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![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.
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![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.
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![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
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$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.
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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.
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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.
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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.
