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Pharma Horizons: leading-edge formulation
This report addresses the key factors shaping pharmaceutical formulation, including regulation, QC and analysis.
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Articles
Combatting drug shortages in the EU: new guidance
New guidance for marketing authorisation holders has been released by the EMA to reduce the impact of drug shortages in the EU. Maurits Lugard and Anna-Shari Melin at Sidley Austin discuss the document and highlight its main points.
IoT could transform the pharma industry through these steps
Adopting IoT systems as a pharmaceutical company can provide many opportunities but achieving success can be difficult. James Steiner explains how to effectively integrate IoT solutions into pharma.
Medicine delivery by drone – implications for safety and quality
Drones that transport medicines to emergency situations, urban environments or geographically-challenging locations are increasingly being utilised to improve delivery, however, there are few studies on their impact on drug stability. Here, Paul Royall and Patrick Courtney explore the implications of drone delivery on the safety and quality of medicines.
Defining the ‘New World Order’ of supply chain security
Now that prominent compliance deadlines are nearing in the US, Saudi Arabia and Russia and with the Falsified Medicines Directive (FMD) now in force in Europe, what is going on around the world with serialisation? Allan Bowyer provides a rundown of current events and shares insights into the challenges businesses…
Tc-99m radiopharmaceuticals and in-house chromatographic methods
Technetium-99m (99mTc) is a synthetic radioisotope that is used worldwide to produce radiopharmaceuticals that are mainly used for diagnostic purposes in nuclear medicines. The purity of the final radiopharmaceutical (99mTc-R) can be confirmed by applying chromatographic methods. This method is based on different rates of movement of substances in a…
Analytical method transfer and the supplier change processes for bacterial endotoxin testing
Changes to lab setups become necessary for many reasons, but the important role of quality control should remain consistently accurate. Tim Sandle and Kerry Skinner describe the details to consider when transferring an analytical method between laboratories or when changing your reagent supplier.
Medical cannabis: face-to-face with Dr Amir Englund
Dr Englund discusses his research into medical cannabis, highlighting a range of its potential uses. He also explores some of the challenges that can be faced in clinical trials when investigating cannabinoids.
Thermodynamic probes of cold instability: application to therapeutic proteins
Developing a stable therapeutic protein formulation requires an intimate knowledge of the protein and its physical and chemical properties. In this article, Bernardo Perez-Ramirez and Robert Simler discuss the thermodynamic consequences that low temperature can have on the aggregation tendencies of a protein.
Pernicious microorganisms: risks of contamination in pharma
Some pharmaceutical manufacturers can struggle to keep microorganisms away from their facilities, which sometimes goes unnoticed until it is too late. While there are numerous threatening microorganisms, this article focuses on some of the most troublesome, highlighting the hazards they pose and analysing how manufacturers can prevent microbial contamination in…
Excipients in drug formulations
Excipients are integral components of pharmaceutical drug products. Their demand is expected to increase over the next five years owing to their ability to perform various functions such as improving active pharmaceutical ingredient (API) stability, modifying drug release and taste masking. Here, Prateeksha Kaul explores the factors and trends that…
Beyond nutrition: vitamins and n-3 polyunsaturated fatty acids as APIs
Active pharmaceutical ingredients (APIs) are important compounds used in the manufacture of pharmaceutical drug products. Eric Ciappio discusses the potential of vitamins and n-3 polyunsaturated fatty acids (PUFAs) as APIs, with a focus on their clinical relevance.
Guide to Data Integrity
In this guide to data integrity, OSIsoft showcase their services and highlight how they stand out from the crowd.
Data integrity by design
The PI System serves as a single source of truth for all operational data, enabling pharmaceutical companies to design the right supply chain to meet business goals.
ICH Q12: Technical and regulatory considerations for pharmaceutical product lifecycle management
The International Council on Harmonisation (ICH) is drafting guidance for product lifecycle management (ICH Q12) – currently stage 2b, which requires application of the concepts of Quality by Design (QbD) to ongoing lifecycle management and change control. Dave Elder dissects the guidance and discusses considerations for industry professionals.
Expert view: Biologics driving innovation in LC-MS analytical chemistry
Over the last few years, biologics have continued to make up an increasing proportion of biopharmaceutical sales and pipeline candidates. Cory E Muraco and Wayne Way discuss current trends in biologics analysis.
