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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
Can calorimetry provide accurate estimates of long‑term stability for monoclonal antibodies?
Differential scanning calorimetry (DSC) has been one of the most widely used techniques to characterise the temperature stability of monoclonal antibodies (mAbs) and provide important information in formulation optimisation. However, despite its widespread use, not all the information contained in DSC data, especially denaturation kinetics, is routinely extracted. In this…
Advanced MALDI imaging breaks ground in pharmaceutical research
Dr Carsten Hopf and his team are using MALDI imaging in several applications, including drug metabolite and formulation distributions in tissues. This article investigates how this content-rich technique is enabling researchers to gain unique insights to facilitate faster and better drug discovery.
Hitting the target – refining anticancer nanomedicine development
Mahfoozur Rahman and Sarwar Beg explain why we need to change tack from traditional formulation-driven development to a target-based approach in order to increase success with anticancer nanomedicine in the clinic.
Single-use strategies for downstream processing
All therapeutic developers and manufacturers are under intense pressure to improve efficiency and productivity and reduce costs, all while maintaining the highest quality standards.
Sartorius Stedim Biotech – offering innovative single-use technologies for advanced bioprocessing
Innovations in single-use process automation are driving single-use adoption into commercial biologics facilities. Here, Sartorius Stedim Biotech (SSB) shares its latest service offering.
Expert View: Annex 1 updates: The impact of microbial ID strategy on cleanroom qualifications for pharma manufacturers
Dr Lucia Ceresa discusses the importance of accurate microbial IDs for cleanroom performance qualification and the risks of inaccuracies or failures.
Expert View: Data integrity in the QC micro laboratory
The quality control (QC) microbiology laboratory plays an essential role in pharmaceutical manufacturing and product release. Jessica Rayser discusses the importance of data integrity to ensure safe and effective products are manufactured.
AdvantaPure: Manufacturers of high purity tubing, hose and single-use systems
AdvantaPure® manufactures high purity flexible tubing and hose, molded tubing manifolds and filling assemblies, and BioClosures® container closures for single use.
Guide to Single-Use
In this Guide to Single-Use, four pharmaceutical manufacturers present their services and demonstrate their unique offerings as well as an exploration of the future of single-use.
Safeguard patients’ safety with extractables and leachables studies
SGS Life Sciences offers tailored study design and testing for extractables and leachables (E&L) in finished pharmaceutical packaging, process equipment and medical devices, and leachables in final product for clients using single-use systems (SUS).
Expert View: Reaching for the (lyo) stars – the unmatched development and scale-up platform for freeze drying
This article focuses on how formulation data can be utilised to create optimal freeze-drying cycles for a specific product based on the unique process analytical technology (PAT) tools and technologies available in SP Scientific’s LyoStar™ 3, a leading freeze dryer for cycle development.
Manufacturing, Packaging & Logistics In-Depth Focus 2019
The articles in this In-Depth Focus delve into the effectiveness of the FMD and why it is necessary as well as how drug manufacturers need to become innovative in their processes.
Bioprocessing & Bioproduction In-Depth Focus 2019
This In-Depth Focus includes articles estimating the long-term stability of mAbs and exploring an automated approach in continuous biopharma production.
Formulation, Development & Delivery In-Depth Focus 2019
This In-Depth Focus investigates anticancer nanomedicine developments and the future of MALDI imaging for pharmaceutical formulation research.
QA/QC & Analytical Techniques In-Depth Focus 2019 featuring Environmental Monitoring
This In-Depth Focus highlights why bio-fluorescent particle detection is an effective method for enumerating present microbes and discusses ICH Q10 knowledge management; presenting five tips for improving your company’s knowledge management.
