FEATURE ARTICLES
At the ISPE Annual Meeting & Expo, I had the chance to sit in on a presentation by Philippe Cini, partner for A-Connect, who introduced his data-focused method of process understanding to recognize defects early, make process changes quickly and stay on schedule.
- 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
- How To Improve Sponsor–CMO Collaboration Around Digital Deviations
- Innovation, Growth (and Happiness) Projected for Pharma
PHARMA ONLINE WHITE PAPERS
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![GettyImages-2152418328-ADC-antibody-drug-conjugate-3d]( "Antibody-Drug Conjugates – Catalysts For Chemistry")
Antibody-Drug Conjugates – Catalysts For ChemistryReview the complexities of developing linkers – chemical moieties which attach a drug payload to an antibody – and considerations when identifying a CRO for ADC research and development.
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Avoiding The Pitfalls Of PQR10/9/2024
Explore the fundamentals of Product Quality Reviews (PQRs), common challenges manufacturers face, strategies for streamlining PQRs, and solutions that aim to unlock the potential of a "real-time PQR."
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Best Practices In Formulation And Lyophilization Development: Proteins, mAbs And ADCs10/16/2024
Discover how advancements in pharmaceutical freeze-drying are reshaping the process through better product understanding, precise process control, and innovations in equipment efficiency.
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A Guide To Accelerating Cell Line Development For Commercial Production7/11/2025
Explore the challenges associated with cell line development in the production of biologics, and solutions that can help biotech developers evade the pitfalls of misinformed decision-making.
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Compliance with Annex 1: Sterile Fill/Finish for Early Phase Clinical Supplies5/5/2025
Grasp the strategies for Annex 1 compliance, focusing on Contamination Control Strategy, Pre-Use Post Sterilization Integrity Testing, and critical zone controls to secure aseptic manufacturing processes.
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Manufacturing Challenges With High Concentration Biologics3/18/2024
Explore key process operations, some of the challenges in manufacturing high-concentration biologics, and factors to consider for process optimization.
PHARMA ONLINE APP NOTES & CASE STUDIES
- A Cost-Effective Alternative To Traditional Protein A Resin Chromatography
- Production And Clarification Of Lentiviral Vectors
- A Simple And Accurate Method To Quantify Molar Concentrations
- BSL-3 Mobile Biocontainment Laboratory For Vaccine Development Research
- Bioanalytical Quantification Of A Biotherapeutic Peptide
NEWSLETTER ARCHIVE
- 12.05.25 -- ISPE Awards 8 Innovative Pharma Facilities
- 12.04.25 -- Process Validation: Working Toward Harmonization Of Terms Used To Identify Validation Lots
- 12.04.25 -- STREAM Edition: Quality Control Failures And Solutions
- 12.03.25 -- 3D Printing, Smart Packaging, And The Future Of Drug Delivery
- 12.02.25 -- Solve High-Viscosity Challenges: Predictive Modeling Approaches & Data-Driven Insights
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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Techceuticals Announces 2026 Solid Dosage Manufacturing Process Training Schedule12/5/2025
echceuticals, a leading authority in pharmaceutical manufacturing education, is pleased to announce its 2026 Solid Dosage Manufacturing Process Training series—three opportunities for professionals to gain practical, hands-on instruction in tablet and capsule production. Each session is designed to equip attendees with the skills and process knowledge needed to develop, manufacture, and troubleshoot solid oral dosage forms with confidence.
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Quotient Sciences And Intrepid Labs Form Strategic Partnership To Accelerate AI-Guided Formulation Development12/4/2025
Under the new agreement, Quotient Sciences will have access to Intrepid’s machine learning model, ANDROMEDA, the first AI platform to develop and optimize clinical performance of drug products. The platform is designed to significantly reduce formulation development timelines, reduce API demands and increase formulation understanding, helping clients reach critical milestones faster and improve confidence in clinical success.
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Large-Capacity Double Planetary Mixer Ideal For Highly Viscous Materials11/26/2025
ROSS recently completed the largest Double Planetary Mixer in its US history, a Model DPM-750 capable of mixing up to an impressive 750 gallons per batch and engineered with safety features for a Class I, Division 1, Group D hazardous environment. This heavy-duty mixer delivers the robust agitation required for ultra-high viscosity materials while adhering to demanding safety standards.
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CSL To Build Out U.S. Plasma Capabilities Through $1.5B Investment11/24/2025
Global biopharma leader CSL (ASX:CSL; USOTC:CSLLY) today announced plans to expand its U.S. presence over the next five years, resulting in approximately US$1.5b in U.S. capital investments. These investments will generate hundreds of high-quality American jobs, strengthen U.S. manufacturing capabilities of plasma-derived therapies (PDTs), and help secure the U.S. medicine supply chain. This reflects CSL’s commitment to meet the growing clinical need for immunoglobulin (Ig) over the long term.
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Equipment Auction Announced For Sutro Biopharma Assets11/24/2025
December 15-16, 2025: Featuring late-model lab, R&D and manufacturing equipment surplus to future needs of Sutro BioPharma: spray dryer, chromatography systems, Westfalia seperators, HPLC’s & more.
