EDITORIAL SECTION
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STRATEGY
Smarter Pharma
Quality management systems QMS are the backbone of pharmaceutical manufacturing ensuring safe products
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RESEARCH DEVELOPMENT
Cytiva Laboratory capsule filters
Our singleuse selfcontained filtration solution
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CLINICAL TRIALS
Why Clinical Trials Need Digital Endpoints
According Citeline the average success rate for bringing a Phase candidate to market has dropped to an alltime low of just
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MANUFACTURING
Ensuring Quality and Compliance in Biopharma
Ensuring quality and regulatory compliance in the biopharmaceutical industry is critical to safeguarding product safety and efficacy
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Information Technology
The Cost of Bad Data
Modern pharmaceutical research generates an unprecedented volume of information Data from genomic sequencing
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Biopharma
Reimagining Global Biomanufacturing Capacity with Continuous and Modular Systems
Biotechnology is fueling the ongoing expansion of the global market for a broad array of goods
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EXPERT Talk
Compliance to Competitive Advantage in Pharma Supply
Compliance gets you through an audit Resilience gets medicines to patients on the day something unexpected happens The DSCSAs enhanced requirements took effect November but real interoperability required three more rounds of accommodation phased implementation with the smalldispenser
Advisory Board
KNOWLEDGE BANK
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Articles
Sustainability in Pharma Manufacturing: A Focus on Green Practices
The pharmaceutical industry is pivotal to global healthcare but its manufacturing processes typically carry a significant environmental burden In recent years there has been an increasing recognition of the importance of sustainability in pharmaceutical manufacturing
Optimizing Pharmaceutical Viral Vector Production: Techniques and Challenges
Pharmaceutical viral vectors have emerged as powerful tools in gene therapy vaccine development and biotechnology research The ability of viral vectors to deliver genetic material into target cells
Multi-Omics Integration: Accelerating Precision Drug Development
The economics of pharmaceutical RD are dominated by a single line item that never appears on a balance sheet the programmes that did not work Only about one clinical programme in ten reaches approval and the cost of the nine that do not is carried entirely by the one that does
From Molecule to Market: Building a Regulatory-Ready Manufacturing Strategy
Every pharmaceutical executive can recite the journey from molecule to market Far fewer can say with confidence at which point in that journey their manufacturing strategy became capable of withstanding a regulatory inspection The distinction matters more than it once did Approval timelines are compressing
Beyond Manual Literature Screening: From AI Automation to Decision Preparation in Pharmacovigilance in Europe
As of August the EU AI Act is generally applicable although some obligations for highrisk AI systems apply at later dates For pharmacovigilance organisations a key consideration is to determine the role and classification of each AI system under the Act rather than assuming that AI used in PV is automatically classified as highrisk AIliteracy requirements are already applicable while provider and...
Nanosizing: An Enthralling Strategy to Improve the Systemic Availability of Poorly Soluble Drugs
To enable the effective preclinical testing efficacy and safety evaluation followed by firstinman studies formulation scientists must come up with effective strategies to achieve the desired bioavailability of these poorly soluble compounds
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Techno Trends
University of Dundee’s Cabamiquine Shows Promise for Single-Dose Malaria Treatment
Researchers at the University of Dundee have reported encouraging clinical results for cabamiquine a novel antimalarial compound being developed as a potential singledose treatment for malaria
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Projects
Genentech to Invest US$750 Million in Oregon Device Fill-Finish Facility
Genentech a member of the Roche Group plans to invest approximately US million in a new device fillfinish manufacturing facility at its acre campus in Hillsboro Oregon The project will add endtoend manufacturing
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Research Insights
One-month physicochemical stability study of idarubicin prepared in polyolefin-type bags for the treatment of hematological diseases
Idarubicine is a mainstay of the treatment strategy for hematological cancer The literature lacks stability data that comply with current preparation practices and recommendations for conducting stability studies
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whitepaper
Post-Translational Modifications in Drug Discovery: From Molecular Regulation to Clinical Impact
For decades the central dogma of molecular biology has anchored our understanding of cellular function DNA to RNA to protein But this linear view is incomplete A growing body of evidence shows that much of biologys
TOP ARTICLES
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1
Optimizing Pharmaceutical Viral Vector Production: Techniques and Challenges
Kate Williamson
This article explores techniques and challenges in optimizing pharmaceutical viral vector production for gene therapy and vaccine development. Topics include vector design, cell culture, purification,...
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2
Multi-Omics Integration: Accelerating Precision Drug Development
Lakshmi
Roughly nine in ten clinical programmes fail, most often because the target was wrong. Multi-omics integration attacks that failure directly, asking whether independent molecular layers converge on th...
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3
From Molecule to Market: Building a Regulatory-Ready Manufacturing Strategy
Lakshmi
Regulatory readiness is still treated by many pharmaceutical organisations as a late compliance exercise, bolted on once a molecule has been designed, scaled and transferred. That sequencing has becom...
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4
Beyond Manual Literature Screening: From AI Automation to Decision Preparation in Pharmacovigilance in Europe
Andreas Hofmann
Artificial intelligence can increasingly extract, structure, and compare pharmacovigilance-relevant information from scientific literature. The key question is no longer whether AI can support literat...
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5
Nanosizing: An Enthralling Strategy to Improve the Systemic Availability of Poorly Soluble Drugs
Dr. Yogeshwar Bachhav
Dr. Chandrakantsing Pardeshi
Dr. Raju Sonawane
The majority of the NCEs in the pipeline, especially in the case of oncology and anti-infective indications, are poorly soluble and have posed a major threat to the overall drug development process.
press releases Read more...
BioLife receives US patent for novel effervescent tablet technology for oral peptide delivery
BioLife announced today that the US Patent and Trademark Office has granted US Patent B for its novel oral peptide delivery technology via effervescent tablets It was developed for current and future peptide therapies for obesity diabetes and metabolic disorders
Prelude Therapeutics Receives FDA Clearance of Investigational New Drug (IND) Application for PRT13722, Its First-in-Class Oral KAT6A Selective Degrader
Prelude Therapeutics Incorporated Nasdaq PRLD a precision oncology company today announced that the US Food and Drug Administration FDA cleared the Company to proceed with a Phase study under
Electra Therapeutics Announces Initiation of a Phase 1 Trial of ELA822, a Novel SIRPγ-Specific Antibody Designed to Treat T Cell-Mediated Immune and Inflammatory Diseases
Electra Therapeutics a clinicalstage biopharmaceutical company focused on pioneering a new class of precision medicines for the treatment of immunemediated diseases and cancer today announced
Insilico Medicine Doses First Patient in GENESIS-IPF-3, the World's First Phase III Trial of a Generative AI-Driven Innovative Drug
Insilico Medicine Insilico HKEX a clinicalstage biotechnology company powered by generative AI today announced that it has dosed the first patient with Rentosertib known as ISM INS
Events Read more...
14 - 16
Sep 202614 - 15
Sep 202616th American DDF Summit
Omni Boston Hotel at the Seapo...
15 - 17
Sep 2026COPD Drug Development Summit 2026
Street, Boston, MA 02210, USA
21 - 23
Sep 2026Cell & Gene Therapy World Conference
Miami, Florida, USA
21 - 23
Sep 2026Cancer R&D World Conference
Hilton Garden Inn Miami Dolphi...
22 - 23
Sep 2026PDA Advanced Parenteral Therapeutics & Quality
Illume Hotel Taipei, Taiwan
22 - 24
Sep 2026InsurInnovator Connect Asia
Singapore
28 - 01
Sep 2026Discovery on Target 2026
Boston, MA, USA
LATEST NEWS Read more...
Renova Pharmaceuticals Launches First Three US Generic Products
Renova Pharmaceuticals has launched its first three generic products in the US marking a major milestone as the company moves from developing its product and regulatory pipeline to establishing a commercial presence in the US generics market
Community Clinical Research Joins PhaseWell Research to Expand CNS Clinical Trial Access in Te
PhaseWell Research has partnered with Community Clinical Research CCR in Austin Texas to strengthen its inpatient central nervous system CNS research capabilities and expand access to clinical trials across Texas
Sysmex Europe and Cytek Biosciences collaborate to expand access to advanced clinical flow cytometry
Sysmex Europe SE and Cytek Biosciences Inc have announced a strategic collaboration across more than a dozen European countries to improve clinical flow cytometry workflows and expand access to advanced diagnostic solutions
Ratio Therapeutics and RayzeBio enter collaboration to advance novel radiopharmaceutical programme
Ratio Therapeutics Inc has entered into a research collaboration and licence agreement with RayzeBio Inc to advance a new radiopharmaceutical programme focused on two undisclosed targets
HCW Biologics Signs Exclusive Distribution Agreement with Akron Biotech for HCW11-006
HCW Biologics Inc a USbased clinicalstage biopharmaceutical company has entered into an exclusive distribution agreement with Akron Biotech to commercialise HCW as a reagent for producing highly functional human CART cells
Sernova and Seraxis to Merge and Form BetaNova Biotherapeutics for Type 1 Diabetes Cell Replacement
Sernova Biotherapeutics Inc and Seraxis Holdings Inc have entered into a definitive merger agreement to combine their technologies and create BetaNova Biotherapeutics a clinicalstage biotechnology






