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MHRA updates biologic quality guidance document
The UK Medicine and Healthcare products Regulatory Agency has released a revision to its standards for ensuring high quality of biologic products.
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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…
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Bioproscessing & 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.
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European Pharmaceutical Review Issue 4 2019
This issue includes an investigation into the potential for continuous production lines in biopharma, information on new guidance released by China on their regulatory processes and an assessment of the FMD to improve the drug supply chain. Also within the issue are articles on nanomedicine development, monoclonal antibodies and pharmaceutical…
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Cannabinoids in pharma series: the challenges of working with cannabinoids
This series investigates cannabinoids and pharmaceutical interest with industry experts explaining the position of the ingredient. In this second piece, we discuss the challenges, legal implications and perceptions of cannabinoids.
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Assessing host cell protein contamination in biotechnological products
Purification of a drug from host cell protein contaminants can be challenging, with low-level contamination often remaining after purification. Vanda Dolabela de Magalhães shares discussions on the subject from six Brazilian companies working in the biotech field.
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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…
Whitepapers/App Notes/Posters
Scientific poster: Advantage of antibody based selectivity in the purification of biologics
ADVANCES in biotherapeutics are generating an increasing range of complex molecules that present unique and often complex purification challenges.
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European Pharmaceutical Review Issue 3 2019
In this issue we explore reasons behind critical key drug shortages in the EU, whether viability methods effectively detect all viable organisms and how companies can future-proof their digital technologies ahead of Brexit. Also included are articles on higher order protein structure, FMD compliance and Raman spectroscopy.
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Pharmaceutical intermediates market to see growth
The global pharmaceutical intermediates market is likely to see year-on-year growth in 2019, by an estimated 3.6 percent rate.
Whitepapers/App Notes/Posters
Whitepaper: Analytical criteria in bacterial endotoxin testing using LAL and rFC
This article covers the analytical criteria that apply to Bacterial Endotoxin Testing (BET) using Limulus Amebocyte Lysate (LAL) or recombinant Horseshoe crab Factor C (rFC) for the bioactivity determination of endotoxin in aqueous solutions, such as pharmaceuticals and medical device extracts. It explains the importance of these criteria for accurate…
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Pharmaceutical corridor between Hong Kong and Brussels opens
The pharma corridor between Hong Kong and Brussels Airport assures handling quality for temperature-sensitive pharmaceuticals.
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Navigating roadblocks to clinical success: from molecule to clinic
For emerging biotech and small companies in early-stage clinical development, accessing the market as quickly as possible is of paramount importance. Biopharma executives must make important decisions at this stage that will impact the success of their commercial strategy. The key to success is making the right decisions at the…
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Ensuring supplier and compounded drug quality
It is paramount that manufacturers and their suppliers ensure that the quality of compounded drugs are high, by preventing risks of contamination...
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Data integrity and compliance with drug current good manufacturing practices
The FDA has provided guidance on data integrity and compliance; two areas extremely important for pharmaceutical businesses and manufacturers to adhere to...