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Market Reports
How to comply with FDA-imposed nitrosamine impurity testing
The detection of nitrosamine impurities in commercially available drugs has recently prompted the US FDA to issue multiple product recalls and mandate additional testing to safeguard consumer health and safety; Michael Walker, Technical Expert at Intertek Pharmaceutical Services, and Jon Bardsley, Vertical Marketing Specialist, Pharma and BioPharma, Thermo Fisher Scientific, report
Excipient innovation for enhanced patient compliance: part II
Formulation can be challenging, particularly when working with excipients such as sugar alcohols. However, a new line extension from SPI Pharma offers a solution that leverages the patient-centric benefits of mannitol while avoiding common drug development problems and simplifying manufacturing
Future-proof DMPK studies for next-generation therapeutics
SCIEX's Lei Xiong, Rolf Kern and Elliott Jones explain the top five reasons why you can’t count on ligand-binding assays to study the drug metabolism and pharmacokinetics of biologics
Tackling coronavirus with AI-derived combination drug products: Part I
The ongoing spread of COVID-19 is risking the lives of millions of rare disease patients around the world. Dr David Brown, Chairman and cofounder of Healx, believes the company’s data-driven AI platform is perfectly positioned to support the efforts to find effective treatments and, within weeks, predict which known drugs can be repurposed to treat other conditions
New date announced for Manufacturing Chemist Live
The inaugural conference will now take place on 28-29 October 2020
Excipient innovation for enhanced patient compliance: part I
Formulation can be challenging, particularly when working with excipients such as sugar alcohols. However, a new line extension from SPI Pharma offers a solution that leverages the patient-centric benefits of mannitol while avoiding common drug development problems and simplifying manufacturing
Sustainability and innovation in the complex combination therapy sector
The patient and commercial benefits of bringing new drugs to market in the shortest possible time are well recognised; potential methodologies to reduce the development cycle and accelerate drug product approvals are constantly being explored. As a result, other targets, including the environmental efficacy of a therapy, have traditionally been a distant, secondary objective. Bespak's Jay Bhogaita, Business Director, reports
Delivering certainty in uncertain times
Contract manufacturing organisations (CMOs) in the pharmaceutical sector operate at the sharp end of an industry in which one mistake or delay could be serious or even fatal. Rodney Steel, CEO of the British Contract Manufacturers and Packers Association (BCMPA), discovers how CMOs have become experts in predicting the future, ensuring that nothing is left to chance
Service in times of bits and bytes
Whoever talks to the service experts at Syntegon Technology, formerly Bosch Packaging Technology, communicates both digitally and globally. The shift from analogue to bits and bytes has not only changed communication between service employees and customers. In the course of digitisation, the company has modernised and expanded its entire service portfolio — and has reinvented itself to a certain extent
How AI will disrupt drug development
In the last 4–6 years, companies have been experimenting with new approaches that utilise the latest in artificial intelligence (AI) and machine learning technologies to identify new molecules and validate new drugs faster and more efficiently. Egor Kobelev, VP of Healthcare and Life Sciences at DataArt, examines some of the ways these breakthroughs are transforming drug discovery
Opening the aperture: taking a wider view of the inhalables market
With a new company strategy in place and a combined focus on both drug and device development, Dr Kevin Robinson spoke to Vectura’s new CEO and Executive Director, Will Downie, about the current and future market for inhaled therapies
Rethinking HPLC degassing with novel flat film technology
During the first three decades of liquid chromatography (LC) use, outgassing in the mobile phase was a key challenge in routine LC workflows. However, since the emergence of online degassers in the 1970s, these devices have become an ordinary component of most LC systems and, therefore, their development is often overlooked
Expanding globally: building on a European presence
To build the overseas presence of Federal Equipment Company and solidify our status as a global provider of equipment solutions, we have opened an office in the Netherlands, reports Paul Sombekke, European Business Development Manager
Granulation: an established technology in a changing world
Optimising the granulation process — the most important unit operation during the production of pharmaceutical oral solid dosage forms — is not only a critical aspect of operational excellence, it also plays a major role in preventing downstream compression problems
John Baker: life sciences need to address the reproducibility crisis
The head of product innovation at Abcam says it is crucial that the whole industry finds ways to de-risk the route to the patient as early as possible
Optimise desiccants with 3D validation software
Baltimore's CFD model brings predictive science to validation. Desiccants are tested for performance over time, bringing cost-efficiency to the forefront. Dr Mark Valentine explains
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Terminal sterilisation versus aseptic filling: ensuring drug product safety
The sterility of drug products is critical to patient safety. Choosing between terminal sterilisation or aseptic processing to achieve this should reflect the final product’s physical attributes, the required sterility assurance and contamination-control regulations such as EU GMP Annex 1
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US mRNA policy shift: are vaccine headwinds accelerating oncology focus?
With Washington’s stance on mRNA vaccines cooling, Manufacturing Chemist examines whether policy and funding signals could influence the pharmaceutical industry’s most commercially promising frontier: oncology therapeutics
Panthera joins the Association of Multisite Research Corporations (AMRC)
Membership strengthens Panthera’s ability to collaborate across the industry, contribute to collective advocacy and help shape the future of clinical research
Empowering patients with self-administration drug delivery devices
Incorporating self-administered drug-device combination products into clinical trials benefits patients and manufacturers alike, reports Bill Welch, Executive Director of Market Development at PCI Pharma Services
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From stockpiles to smart supply chains: how industry wants to fix Europe’s drug shortages
An EU-level stockpile may work, but only if it’s flexible, closely monitored and built with logistics in mind. Industry players say drug security will depend less on volume and more on data, digital oversight and early collaboration throughout the supply chain
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