Author Archive

QA/QC Focus: Validation/Mapping Studies

Patricia Van Arnum PharmTech editor As more companies try to ensure that their validation activities are compliant and cost-effective, it has become increasingly important for quality professionals and validation technicians to manage costs and reduce downtime by accurately evaluating their validation equipment needs. This is particularly the case in validation/mapping studies. Pharmaceutical Technology will hold a live webcast, “Optimizing Validation/Mapping Studies for GMP Compliance,”  on Wednesday April 10th at 11:00 AM EST to address this issue. Read more »

The Next Horizon: Single-Use Technologies for Finished Drug Product Manufacturing

Patricia Van Arnum PharmTech editor Biopharmaceutical production is an often discussed application for single-use technologies, but single-use technologies also have application for small-scale finished drug-product manufacturing for producing clinical-trial materials. An educational webcast by Pharmaceutical Technology, “Accelerate Sterile and Non-Sterile Clinical Trial Manufacturing with Single-Use Technologies,” on Wednesday Mar. 6th examines this application. Read more »

Informex Perspectives: Still a Small-Molecule World

Patricia Van Arnum PharmTech editor As fine-chemical producers, custom manufacturers, and pharmaceutical companies gathered this week for Informex in Anaheim, California, one observation stands out: for all the inroads that biologic-based drugs have made, the pharmaceutical industry remains a small-molecule marketplace. Read more »

Gaining a Market Pulse at CPhI

Patricia Van Arnum PharmTech editorThe perception of buyers of pharmaceutical ingredients and contract services in how they see market conditions and their own individual business prospects is an important barometer in assessing the market for pharmaceutical outsourcing and ingredients. The results of a survey released this week at CPhI Worldwide in Madrid were largely positive as buyers assessed market and business conditions for the next 12 months. Read more »

Changing Industry Models at Work at CPhI

Patricia Van Arnum PharmTech editorAs fine-chemical producers, contract manufacturers, and pharmaceutical/biopharmaceutical companies meet this week in Madrid at CPhI Worldwide, what are the key issues on the minds of industry players? Read more »

Strategies for Effective Biologics Outsourcing Examined at CPhI

Patricia Van Arnum PharmTech editorBiologic-based drugs are increasingly important in the drug pipelines of pharmaceutical companies. Strong growth is projected for biologic-based drugs, and a crucial issue is whether the outsourcing model for biologic-based drugs will follow a similar path as the model for outsourcing small-molecule development and manufacturing or will new paradigms emerge. That question was addressed at one of the sessions at the CPhI Pre-Connect Conference this week in Madrid. Read more »

Omega-3s Prescription Products: A Case Study of Innovation

Patricia Van Arnum PharmTech editor Innovation is the cornerstone of the pharmaceutical industry. The challenge to innovation not only entails identifying drugs with clinical efficacy but also in being able to produce and deliver the desired drug compound. An upcoming Pharmaceutical Technology webcast, Omega-3 Innovations in Pharmaceutical and Diagnostic Markets, will examine the latest developments for omega-3 prescription drug products, their regulatory status, and recent advances in softgel drug-delivery technologies for omega-3 products. Read more »

PharmTech Biomanufacturing Partnership Conference: The Rising Bar in Outsourcing

Patricia Van Arnum PharmTech editorWhat will be the future of pharmaceutical outsourcing? What factors will influence the relationships between sponsor companies and contract service providers and what practical solutions are both seeking? These questions were addressed at a conference this week in Philadelphia, Bio/Pharmaceutical Manufacturing Partnerships, organized by CBI in conjunction with Pharmaceutical Technology. Read more »

Bioavailability Enhancement through Lipid-Based Drug Delivery

Patricia Van Arnum PharmTech editor Improving bioavailability of poorly water-soluble drugs is an ongoing challenge for formulation scientists and is of crucial importance to advance clinically promising drug candidates. A Pharmaceutical Technology webcast, Bioavailability Enhancement through Lipid-Based Drug Delivery, will examine advances in lipid-based drug delivery systems for enhancing the bioavailability of absorption-limited small and large molecules. Read more »

Single-Cell Genomics Advancing Molecular Biology

Patricia Van Arnum PharmTech editorThe potential of single-cell genomics took a step forward recently with the announcement by The Broad Institute and Fluidigm Corporation of a new research center focused on developing research methods and discoveries in mammalian single-cell genomics. The Single-Cell Genomics Center is expected to act as a hub for collaboration among single-cell genomics researchers in many fields, including stem cells and cancer biology. Read more »

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