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Medical device design – a key consideration when entering biosimilars market
A recent industry report projects a boom in the biosimilars market over the next three years and highlights key considerations for meeting its potential.
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Biologics
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Expert view: Biologics driving innovation in LC-MS analytical chemistry
Over the last few years, biologics have continued to make up an increasing proportion of biopharmaceutical sales and pipeline candidates. Cory E Muraco and Wayne Way discuss current trends in biologics analysis.
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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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Brochure: Drug Development Services
Your Global Drug Development Organization For Analytical Laboratory Testing and Clinical Research.
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FDA accepts Biologics License Application for V920 Ebola vaccine
A Biologics License Application and priority review has been approved by the FDA for an investigational Ebola vaccine.
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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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Treatment approved for young children with severe eosinophilic asthma
Nucala is the first biologic approved in the US for six- to 11-year-old children with severe eosinophilic asthma by the FDA.
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Biologics and generics reported to save NHS £700m
An NHS-wide plan to use more generic and biologic products has reportedly saved the healthcare provider £700 million since 2016.
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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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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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Bioprocessing & Bioproduction In-Depth Focus 2019
The process of manufacturing a biotherapeutic drug entails numerous quality control measures to ensure safety and efficacy. The articles in this in-depth focus discuss higher order structure analysis and host cell protein contamination issues.
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Expert view: Low Endotoxin Recovery (LER)
The Parenteral Drug Association (PDA) has recently published Technical Report No. 82 (TR82) on the topic of Low Endotoxin Recovery (LER), providing both consensus to the science and data behind the analytical issue, as well as to analytical and mitigation strategies.
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Scientific poster: Nuvia aPrime 4A: a hydrophobic anion exchange resin for refined selectivity and recovery
The elimination of product and process related impurities is essential to the safety and efficacy of biopharmaceuticals.
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Expecting the unexpected in drug formulations
The increasing complexity of formulations and active biological products raises new challenges for pre-filled syringe development. James Mellman, Device Manager at Novartis, speaks to Nikki Withers about the challenges of selecting the right primary packaging for injectable formulations and how he has learnt to expect the unexpected.
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Biopharmaceutical contract manufacturing market expected to rise 10.6 percent
A study has predicted that the global biopharmaceutical contract manufacturing market will grow by 10.6 percent from 2017 to 2027.
