EDITORIAL SECTION

Articles

Risk Management in Pharmaceutical Manufacturing

The pharmaceutical industry operates under strict regulatory oversight because medicines directly affect patient health and safety Manufacturers must consistently produce products that meet predefined standards of quality safety efficacy identity strength and purity Achieving these objectives requires a proactive approach to identifying and controlling risks throughout the product lifecycle

Digital Biomarkers and Wearables: Transforming Clinical Trial Data Collection

A participant enrolled in a week pharmaceutical trial may spend fewer than six hours inside a clinical site The remaining odd hours of that year the stairs the fatigue the broken nights the good days and the collapsed ones pass unrecorded Clinical development has quietly accepted this trade for decades building enormous capital decisions on a handful of supervised snapshots taken under artificia...

Circular Logistics: A Strategic Advantage for U.S. Pharmaceutical Supply Chains in an Era of Uncertainty

Temperaturerelated failures are estimated to cost the industry billion annually highlighting a nonnegotiable requirement for reliability product integrity and regulatory compliance For manufacturers

Cell and Gene Therapy's Trillion-Dollar Reckoning Is Here

Cell and gene therapies can cure diseases once thought untreatable Yet a string of commercial collapses now suggests that curing the patient and sustaining the business are two very different challenges and the industry is confronting the gap at last

Biosimilars in Europe: Expanding Access and Reducing Costs

The use of biosimilars as a part of modern health care systems is also fairly important especially in the context of the European Union as they can enhance the availability of the required treatments and reduce the costs of the health care sector As biologic medicines are recognized as firstline treatments for critical illnesses such as cancer autoimmune diseases and rheumatoid arthritis biosimila...

How Predictive Maintenance Reduces Downtime in Pharma Plants

The pharmaceutical industry is always under stress to enhance the reliability of the production adherence to the regulations and quality of the products without raising the prices and to maintain a continuous supply Machinery malfunctions are not merely a setback in this highstakes game they may compromise batch integrity postpone life and death treatments and put pressure on the market promises

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 with HPVpositive oropharyngeal carcinoma OPC

Projects

Onyx Scientific to Invest Over US$2 Million (£1.5 Million) in Sunderland GMP Facility Expansion

Onyx Scientific is investing more than US Million Million to expand its Good Manufacturing Practice GMP facilities at its Sunderland UK site The investment will increase capacity for commercial

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

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