ebook: Extractables and leachables: a guide to analytical methods
This ebook takes an in-depth look at advanced analytical methods for extractables and leachables analysis in the pharma industry.
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Articles
Pharmaceutical microbiology: key developments 2022
Here, microbiology experts Tim Sandle, Tony Cundell and AstraZeneca’s Miriam Guest reflect on key developments in pharmaceutical microbiology during 2022.
Bottlenecks in buffer preparation – solving downstream issues for upstream gains
The preparation of buffer solutions is a crucial component in the downstream manufacturing process for biomolecules; however, it is also one of the most resource-heavy and intensive steps. Solving these downstream issues with new approaches is critical to achieving efficiency and commercial gains within the upstream process. Here, Andrea Johnston…
Simplify, standardise, digitalise to transform manufacturing
Here, Sanofi’s Arnaud Robert and Brendan O’Callaghan explore how advances in digital technology, partnerships and new ways of working are supporting manufacture and delivery of medicines for patients across the globe.
Optimising bispecific antibody clonal cell selection with high-throughput analytics
It is possible to manufacture monoclonal antibodies using traditional methods, but the challenges inherent in bispecific antibodies such as low titer, mismatched chains, unwanted fragments and higher aggregation levels require a heightened analytical focus on clonal cell selection. Here, Stuart Jamieson and Alice Harrison at Lonza discuss high-throughput analytical strategies…
mRNA therapeutics: a limitless revolution in medicine
Carsten Rudolph and Christian Plank of Ethris, an mRNA therapeutics and vaccine‑focused German biotechnology company, discuss the current state of the art in the field, including delivery systems and administration of mRNA drug candidates to prevent or treat a plethora of diseases.
Raman mapping to visualise the three-dimensional structure of pharmaceutical tablets
Raman mapping is a powerful tool that can be used to reveal details about the size and spatial arrangement of components throughout a tablet matrix. Here, Andrew Ewing, Don Clark and Fiona Clarke from the Materials Characterisation Team at Pfizer present a 3D imaging approach using Raman mapping to investigate…
Psychedelic research: evaluating the fast-evolving regulatory roadmap
In this article, Aman Khera and Dr Christine Moore of Worldwide Clinical Trials share how regulatory agencies are supporting psychedelic research through expedited pathways and outline some of the key considerations for clinical trials sponsors.
Upstream Bioprocessing In-Depth Focus 2022
Articles on high-throughput analytics for optimising bsAb clonal cell selection and a technology to overcome buffer preparation bottlenecks.
Drug Delivery In-Depth Focus 2022
Articles explore the potential of tryptamines in treatment-resistant depression and drug delivery options for mRNA therapeutics.
Whole genome sequencing and analysis of live biotherapeutic products
Here, Snehit Satish Mhatre and Michael Timm of Eurofins discuss considerations and recommendations for the testing of live biotherapeutic products.
Patient-centred pharmaceutical packaging: are we there yet?
Despite tremendous innovation in the realm of pharmaceutical therapeutics, the packaging of medicines has been staid. In this article, Giana Carli Lorenzini from the Technical University of Denmark investigates the potential of patient-centred pharmaceutical packaging.
Building CO2-neutral, defossilised supply chains for chemicals
Manufacturers of (bio)pharmaceuticals, medical devices and in vitro diagnostics have the opportunity to lead the way in the defossilisation of organic chemicals. Here Martin Held from the Institute of Biotechnology of the Swiss Federal Institute of Technology and Roche’s Stefan Koenig, Martin Olbrich and Jan Backmann propose how to reduce…
Clinical innovation: using digital solutions to deliver the next wave of medicines
Rapid progress in digital health technologies is enriching clinical trial design, improving clinical trial recruitment strategies and harnessing the power of clinical trial data to improve outcomes for patients and guide future research. Here, Natalie Fishburn, Cristina Duran and Serban Ghiorghiu, from R&D at AstraZeneca, discuss the evolving nature of clinical innovation…
Converging knowledge and technology to transform neuromuscular disease treatment
With the emergence of innovative therapeutic technologies and progress in the genetic understanding of diseases, Biogen’s Toby Ferguson explains why it is a promising time for the development of therapies for neuromuscular conditions such as amyotrophic lateral sclerosis (ALS).
