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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
Brexit-tech: overcoming post‑Brexit challenges by driving operational and cost efficiencies
As 31 October draws closer, organisations across all sectors are putting contingency plans in place for whatever the impact of Brexit may be. However, for pharmaceutical organisations already operating in a heavily regulated, highly competitive landscape, the future looks a lot more uncertain than for most. Here, Neal Singh discusses…
Analytical methods used in obtaining higher order structure information from protein therapeutics
The efficacy, safety and pharmacokinetic properties of a protein therapeutic substantially depend on the molecule having the right structure. This article reviews current methods used for obtaining higher order structure information of biotherapeutics.
Regulatory insight: Tadalafil UKSC decision – evolution of the multi-factorial approach
The Supreme Court unanimously dismissed an appeal from the Court of Appeal in Actavis Group PTC EHF & Ors v ICOS Corporation & Anor, upholding its decision that a patent relating to the use of tadalafil in a 1 to 5mg dosage form is invalid for lack of inventive step.…
Implementing global standards to ensure end‑to‑end FMD compliance
Effective drug serialisation and identification is essential for improving the safety of medicines and combatting counterfeits. The Falsified Medicines Directive’s new requirements promise to crack down on the impacts of unsafe drugs. Neil Piper discusses the human cost of falsified medicines and how companies need to increase traceability of individual…
Expert view: Raman spectroscopy
Many researchers are keen to find analytical solutions that generate the chemical fingerprint of a sample at the molecular and cellular level. Overcoming these problems is made possible by label-free techniques such as Raman, SPRi or particle size analysis. This brief overview will identify the benefits of Raman spectroscopy.
Expert View: Eshmuno® CP-FT resin – developed for the flow-through removal of aggregates using frontal chromatography
Eshmuno® CP-FT cation exchange resin is specifically designed to provide efficient removal of monoclonal antibody (mAb) aggregates in the flow-through frontal chromatography mode of operation enabling loading capacities 10-times higher than traditional bind/elute CEX chromatography. It facilitates greater manufacturing flexibility and process intensification while reducing the overall cost for the…
Expert View: Find, classify and identify microparticles with Raman imaging
High-resolution measurements of particles are of great interest in many fields of application. Combining confocal Raman microscopy with particle analysis tools makes it possible to find, classify and identify particles almost entirely automatically.
Manufacturing, Packaging & Logistics In-Depth Focus 2019
Whether by ignorance of the latest best practices, or willful disregard for patient safety, the results of careless practice can often be fatal. The articles in this in-depth focus highlight how regulatory bodies are taking action to raise the industry’s game.
Guide to Informatics & Data Integrity
In this edition, two companies showcase their services and highlight how they stand out from the crowd. The exponential speed of the information technology evolution is rapidly being accepted and integrated into our everyday life, yet it remains a challenge in the laboratory.
ACD/Labs: empowering data-driven decisions
ACD/Labs helps scientific R&D organisations assemble digitised analytical, structural and molecular information for effective decision-making, problem solving and product lifecycle control by their scientists. Their enterprise technologies enable automation of molecular characterisation and product development, and facilitate chemically intelligent knowledge management, data analytics and collaboration – both within organisations and…
Data integrity for cleanroom monitoring
With a continual focus on data integrity and helping our customers meet regulations while generating actionable insights, Particle Measuring Systems provides a complete range of products and services.
QA/QC & Analytical Techniques In-Depth Focus 2019
Analytical techniques for QA/QC purposes are integral to the safe production of therapeutics. This in-depth focus looks at Raman spectroscopy for amorphous phase analysis and discusses the viable but non-culturable (VBNC) state of bacteria in environmental monitoring.
Bioprocessing & Bioproduction In-Depth Focus 2019
The process of manufacturing a biotherapeutic drug entails numerous quality control measures to ensure safety and efficacy. The articles in this in-depth focus discuss higher order structure analysis and host cell protein contamination issues.
Scientific Poster & Whitepaper Gallery 2019
The latest research and developments from Pharma and Biopharma industry experts.
Expert view: Low Endotoxin Recovery (LER)
The Parenteral Drug Association (PDA) has recently published Technical Report No. 82 (TR82) on the topic of Low Endotoxin Recovery (LER), providing both consensus to the science and data behind the analytical issue, as well as to analytical and mitigation strategies.
