The Increasing Importance of Manufacturability in API Development

Rise of AI ML-Powered Accelerators in Pharma Secure Supply Chain

Single Use Technologies (SUT) in Pharmaceutical Manufacturing

Digital Quality Management Systems as Strategic Enablers of Patient-Centric Manufacturing Excellence

Antibody + Drug + Third Party, Antibody + siRNAASO + Third Party

EDITORIAL SECTION

STRATEGY

Strategic Positioning for M&A

The biotechnology sector is characterised by a constant influx of small highly specialised companies

RESEARCH DEVELOPMENT

Cytiva Laboratory capsule filters

Our singleuse selfcontained filtration solutions help reduce contamination risk and lower manual handling

CLINICAL TRIALS

Virtual Clinical Trials

Virtual digital and decentralized are all descriptions of the novel ways that using technology changes

Bio Pharma

Biosimilars and Biobetters

Biosimilars are biologic medical products that are essentially identical to an original product manufactured

MANUFACTURING

Transformative Convergence of AI in Pharmaceutical Manufacturing

The pharmaceutical manufacturing industry is on the cusp of a revolutionary transformation driven by

Information Technology

Transformative Impact of Artificial Intelligence on Clinical Trials

Artificial Intelligence AI has rapidly evolved from a futuristic concept to a transformative tool across various industries

EXPERT Talk

Advancing Biopharmaceutical Innovation Through Cell Encapsulation and Biomimetic Therapeutic Systems

My interest in biopharmaceutical engineering began during my senior year as an undergraduate For my capstone project I worked on the encapsulation of...

Advisory Board

Victor M. Diaz Perez

Kishore Hotha

Joab Williamson

Scott M. Wheelwright

Tamara Miller

Juris Hmelnickis

David Contorno

Svetlana Busiguina

Eiman Shafa

Nigel Cryer FRSC

Hector Alejandro Andonie

Josipa Ljubicic

KNOWLEDGE BANK

Articles

FDA Drug Approval Pathways: Strategies for U.S. Pharmaceutical Companies

Getting a new medicine from the lab bench to a patients medicine cabinet is one of the longest costliest and most heavily scrutinized journeys in American business For every drug that reaches pharmacy shelves thousands of molecules never make it out of early testing The difference between the ones that succeed and the ones that stall often isnt the science alone its the regulatory strategy behind...

Techno Trends

Juniper Biosciences Secures FDA Breakthrough Designation

The US Food and Drug Administration FDA has granted Breakthrough Therapy Designation to Juniper Biosciences JBS Ffluoromisonidazole or FMISO for identifying tumour hypoxia in patients

Projects

Sandoz to Invest US$300 Million in New Biosimilar Facility in Ljubljana

Sandoz is investing approximately US million in a new biosimilar drug substance manufacturing facility in Ljubljana Slovenia The investment will expand the companys inhouse manufacturing capacity

Research Insights

Phycocyanobilin: A potential bioactive compound from Arthrospira platensis targeting LYN protein associated with systemic lupus erythematosus

Phycocyanobilin a bioactive compound derived from Arthrospira platensis C was investigated for its potential role in systemic lupus erythematosus SLE based on its structural similarity to bilirubin

White Papers

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 complexity

press releasesRead more...

Sandoz announces collaboration with mAbxience to expand patient access to life-enhancing biosimilar medicines

Sandoz announces collaboration with mAbxience to expand patient access to lifeenhancing biosimilar medicines Sandoz SIXSDZOTCQXSDZNY the global leader in affordable medicines

Genentech and Roche Announce Grand Opening of Boston R&D Innovation Center

Kincell Bio and Cellipont Bioservices today announced the completion of their merger to form Kincellis Advanced Therapies Kincellis a USbased contract development and manufacturing organization focused on cell therapies and other advanced modalities

Puma Biotechnology Initiates ALISCA®-Lung2, a Phase II Trial of Alisertib in Combination with Paclitaxel for the Treatment of Patients with Advanced Small Cell Lung Cancer

Puma Biotechnology Inc NASDAQ PBYI a biopharmaceutical company announced the initiation of its ALISertib in CAncer ALISCALung Phase II trial PUMAALI NCT of alisertib

OncoC4 Receives FDA Fast Track Designation for Cesalatamig, an Investigational PD-1/VEGF Bispecific Antibody

OncoC Inc a late clinicalstage biopharmaceutical company developing novel medicines for cancer and neurodegenerative diseases today announced that the US FDA has granted Fast Track Designation