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Brochure: Drug Development Services
Your Global Drug Development Organization For Analytical Laboratory Testing and Clinical Research.
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Biologics
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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.
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Routine mass analysis enables greater productivity in biopharma development
Biopharma developers and manufacturers need to know their molecules and understand their manufacturing processes better than ever before. In this article, Mike Wilson discusses the benefits of mass analysis in biopharma and the current challenges of adopting new technologies.
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Biopharma Processing & Development In-Depth Focus 2019
Today’s biopharmaceutical developers need accurate and precise information at all stages of research and development in order to bring safe and effective therapies to patients. This in-depth focus features novel perspectives from industry experts that serve to illustrate which technologies and systems are benefitting this cause.
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Formulation In-Depth Focus 2019
As today’s scientists continue to identify new biopharmaceutical products with potential to treat a wide array of diseases, formulation remains the determining factor in their success. But what is involved in these increasingly complex formulation processes and how do they impact the packaging and delivery systems?
