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First company awarded market authorisation under new Chinese drug law
The mAb tislelizumab has been granted approval from Chinese authorities, making Boehringer Ingelheim Biopharmaceuticals the first MAH under the new system.
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Intellectual property, divestments, fragmentation and the future: M&A in life sciences
Mergers and acquisitions in any market can define the landscape for its players. In this article, Emma Danks of Taylor Wessing reflects on recent M&A activity in the biopharmaceutical industry, highlighting influencing trends and what this might mean for the future.
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Expert view: The future of biologics quality – multiple attribute methodology
Characterisation and quality control of proteinbased biotherapeutics has historically been a lengthy and challenging process due to their complexity and inherent heterogeneity.
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Bioprocessing & Bioproduction In-Depth Focus 2019
Within this in-depth focus are articles exploring the potential of gene therapies and manufacturing viral vectors as well as a discussion on recent M&As within the biopharmaceutical industry.
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European Pharmaceutical Review Issue 6 2019
In this issue are articles that explore the impact of M&As within the life science industry, discuss the security trends for medicinal packaging and investigate genotoxic impurities within pharmaceutical products. Also included are features on nanobot drug delivery systems and Raman as an effective analytical approach.
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Thermodynamic probes of cold instability: application to therapeutic proteins
Developing a stable therapeutic protein formulation requires an intimate knowledge of the protein and its physical and chemical properties. In this article, Bernardo Perez-Ramirez and Robert Simler discuss the thermodynamic consequences that low temperature can have on the aggregation tendencies of a protein.
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Pernicious microorganisms: risks of contamination in pharma
Some pharmaceutical manufacturers can struggle to keep microorganisms away from their facilities, which sometimes goes unnoticed until it is too late. While there are numerous threatening microorganisms, this article focuses on some of the most troublesome, highlighting the hazards they pose and analysing how manufacturers can prevent microbial contamination in…
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Telstar promotes aseptic technology developments for pharma production
At CPhI (Frankfurt, November 5-7 2019), Telstar will be promoting the latest solutions in isolation technology systems, sterilisation and pharmaceutical freeze-drying applications, designed to ensure an aseptic and efficient production of pharmaceutical processes.
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Bioprocessing & Bioproduction In-Depth Focus 2019
The articles in this in-depth focus explain how microbial contamination in pharmaceutical facilities can occur and discuss the impacts of temperature fluctuations on protein aggregation.
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The potential of the Indian pharmaceutical industry
According to research from the Indian Pharmaceutical Alliance, the country’s pharma sector has capacity to grow. This article investigates some of the goals, challenges and proposals the report sets out for the industry.
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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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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.
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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.