Authors


D.F. de Roode

Latest:

Assessing environmental risk of pharmaceuticals

An environmental risk assessment (ERA) is now required for all new pharmaceutical product marketing authorisation applications. The author outlines the steps to this procedure.



Ania Szymanska

Latest:

How to Evaluate a CDMO’s Commitment to Quality

What do you need to ask during the vetting and selection process to ensure your clinical or commercial program won’t be derailed by a quality-related problem?


Amy Williams

Latest:

A Change of Tack for IDMP

EMA has announced a change of plan for the IDMP.


ProteinSimple, a bio-techne brand

Latest:

Leveraging Cygnus Technologies Quality with Fully Automated CHO HCP Assays on Ella: whitepaper:

In this application note, we pair Simple Plex Assays on Ella with Cygnus 3G CHO antibodies for superior sensitivity and data reproducibility throughout bioproduction.


Martin Morrison

Latest:

Data Matrix Barcodes: Print Quality and Popularity On The Up

The 2D Data Matrix barcode is a familiar sight for most pharmaceutical manufacturers as printing is implemented to meet certain regulations.


Paul Larson

Latest:

iMRI-Guided Gene Therapy and Drug Delivery for CNS Disorders

Leveraging real-time MRI guidance for intracranial gene therapy administration potentially improves efficacy and outcomes.


Mark Featherston

Latest:

Revolutionizing Biomanufacturing: The Digitalization Advantage

Digital transformation allows for smarter and connected biomanufacturing operations.


Fluid Air

Latest:

Low Temperature Spray Dryers

Experts in solid dosage technology, offering electrostatic spray dryers, fluid bed systems, and other process solutions used daily to help the pharmaceutical, nutraceutical, food, fine chemical, and biopharmaceutical industries.


Lawrence Liberti

Latest:

ICH Q9: Attaining a Quality-Business Synergy through Quality Risk Management, ROI Analysis, and Highly Capable Facilities

This paper explores the relationship between investing in pharmaceutical manufacturing risk reduction and meeting business objectives.


Marc Venet

Latest:

Handling HPAPIs

The manufacture of high potency active pharmaceutical ingredients (HPAPIs) is on the rise with R&D projects showing a continuing interest in these products.



Paul Van Tilborg

Latest:

Phase-appropriate Analytical Methodology

A phase-appropriate analytical development strategy is crucial, especially for complex (formulated) drug substances.


Konghwa Chiu

Latest:

Spectrophotometric Determination of Lead

The authors developed a reliable spectrophotometric method for determining and measuring trace amounts of lead in various samples.


Adam C. Fisher, PhD

Latest:

Artificial Intelligence in Pharmaceutical Manufacturing

FDA is anticipating how AI may advance manufacturing and improve supply chain security.


Gaurav Tolia

Latest:

The Role of Dendrimers in Topical Drug Delivery

This review provides an update of how dendrimer technology is being applied to the development of novel systems for various topical delivery applications.


Rajeev Singh Raghuvanshi, PhD

Latest:

Assessment of Nanosuspension Formulation for Intranasal Administration

Research suggests that intranasal nanosuspensions offer a promising way to formulate and deliver drugs that are poorly soluble in water to patients with chronic conditions.



Prometheus Group

Latest:

Pharmaceutical Companies Can Optimize Enterprise Asset Management and Achieve Success

An integrated platform that keeps real-time data in a single location can be a major asset for pharmaceutical companies, as it saves time and money, leading to better quality products and higher profits.


BIOGRUND

Latest:

Easy Coloring for Liquid- and Solid-Dosage Drug Forms

***Live: Tuesday, November 24, 2020 at 9am EST| 2pm GMT| 3pm CET*** Coloring as an aesthetic value for a product is becoming more important for pharmaceutical and nutritional products and helps differentiate between various grades of active ingredients. This webcast introduces the world of easy coloring, answers questions about pigments, pigment blends, and how to color solid- or liquid-dosage forms in an efficient way. Register for this webcast to learn how ready-to-use coloring systems can simplify production process.*** On demand available after final airing until Nov. 24, 2021.***


Scott Deakins

Latest:

Serialization: Reducing Counterfeit Drugs and Increasing Sales

An effective data structure and simple communication between production, logistics, and sales are essential for delivering this level of accountability, traceability, and security.


Greg Paddon-Jones

Latest:

Emerging Applications of Vitamin E TPGS in Drug Delivery

The author discusses some new applications of TPGS in the pharmaceutical field that should see this versatile excipient retain its place in the drug formulators toolbox.


Cameron Graham

Latest:

High-Growth Microbial Fermentation for the Manufacture of Biologics

Challenges in fermentation can be addressed through equipment changes, facility design, and process development.


Rasmus Kidmose

Latest:

Accelerating Project Delivery with a Lean Alternative to DBB

Lean delivery offers a promising solution to supply and manufacturing bottlenecks by integrating project teams early on and widening the team’s field of view.


Bioduro

Latest:

Transforming Oral Drug Products for Late-Phase and Commercial Excellence

Webinar Date/Time: Tue, Dec 3, 2024 11:00 AM EST


Maria DiPietro

Latest:

Elaboration, Expansion, and Evolution in Outsourcing of Clinical Research

The rising complexity of clinical research protocols has necessarily expanded the CRO landscape.


Chris Stumpf

Latest:

Untethered Data: Unifying and Contextualizing Drug Discovery Data

Capturing and curating R&D data are crucial to realizing the full value of advanced analytics.


Nusrat Motlekar

Latest:

Designing and Delivering Therapeutic Proteins

An updated book summarizes recent research for formulators and drug-delivery specialists.


H. Gregg Claycamp

Latest:

Elicitation of Expert Knowledge and Probabilities for Controlling Subjectivity in Risk-Based Decision Making

More attention should be given to how expert opinions and judgments are elicited for reducing uncertainty in quality risk management and risk-based decision making.


Kevin E. Noonan

Latest:

Protecting Intellectual Property for COVID-19 Innovations

Opposition to IP protection for COVID-19 vaccines, therapies, tests and other technologies may only prevent eradication and treatment of the disease.