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Biologics - Articles and news items
FDA approves IDE study for bone graft substitute, Cerament G
Industry news / 10 August 2016 / Niamh Louise Marriott, Digital Content Producer
Bonesupport’s Fortify study will evaluate the safety and efficacy of Cerament G as part of surgical repair of open diaphyseal tibial fractures. The trial will enrol up to 230 patients at up to 30 centres globally, with the aim of having at least 50% of the study data coming from US subjects…
Celltrion to develop assay for evidence-based decision-making in anti-TNF treatment
Industry news / 5 July 2016 / Victoria White, Digital Content Producer
Celltrion is to develop laboratory tests that will enable physicians to identify when patients on an anti-TNF drug require a change of dose…
Pfizer breaks ground on new biologics manufacturing facility
Industry news / 17 June 2016 / Victoria White, Digital Content Producer
Pfizer will invest more than $200 million in the development of the state-of-the-art facility that will enable the production of high-quality, complex biologics…
Sanofi makes huge investment in the future of biologics
Industry news / 19 April 2016 / Mandy Parrett, Editorial Assistant
Sanofi has announced plans to invest €300 million to expand its manufacturing and commercial capabilities at its site in Geel, Belgium.
Whitepaper: Bioanalytical support in the development of biologics
Whitepapers, Z Homepage promo / 1 April 2016 / Chimera Biotec
In this publication Imperacer® case studies demonstrate the advantage of broad assay range combined with excellent sensitivity for several Biologics on their way from R&D to clinics…
Integrated, predictive and collaborative workflows in biologics discovery
Webinars / 23 March 2016 / Dassault Systèmes BIOVIA & GlaxoSmithKline
As well as delving into secure data sharing, the speakers from BIOVIA and GSK will discuss implementing the BIOVIA Biological Registration solution. The speakers will highlight the importance of effective IP protection and improved decision-making through an integrated and collaborative platform…
Tecan simplifies large molecule bioanalysis
Supplier news / 2 February 2016 / Tecan
Tecan has launched a fully automated affinity purification solution for the extraction of large biomolecules, such as proteins, antibodies and antibody-drug conjugates…
Meeting biopharmaceutical analytical requirements for subvisible particle sizing and counting
Biologics, Issue 5 2015 / 22 October 2015 / John Carpenter, University of Colorado / Amber Haynes, Fradkin KBI Biopharma / Christina Vessely, Biologics Consulting Group Inc.
Quantifying and sizing subvisible particles in biopharmaceutical products are crucial aspects of formulation development, stability studies, process development, product release and extended characterisation of the final drug product. The particles, which may consist of aggregated proteins, and/or components shed from process materials or container closure systems, can directly impact on the efficacy and immunogenicity of a drug product. Also, they often act as nucleation sites for further protein aggregation and/or lead to the development of larger particles by agglomeration. Measuring the size and concentration of subvisible particles within a formulation is an essential precursor to their effective control, and of growing importance as the industry works towards ‘zero defect’ and ‘essentially particle-free’ products. In this article we consider requirements for subvisible particle measurement within the context of current regulatory expectations, and more broadly, review the technology available to meet them…
Record attendance for Cambridge Healthtech Institute’s Seventh Annual PEGS Europe Summit
Supplier news / 16 October 2015 / CHI
Largest European Event for Biologics Returns to Lisbon from 2-6 November…
What is a biosimilar medicine? NHS England explains all in new publication
Industry news / 25 September 2015 / Victoria White
Drawing on NHS, regulatory, professional and industry expertise, the new “What is a biosimilar medicine?” document provides an authoritative source of reference on the complex topic of biosimilars…
TandAbs: potent and well-manufacturable bi-specific antibodies for immunooncology
Issue 1 2015 / 10 March 2015 / Michael Weichel, Kristina Ellwanger, Ivica Fucek, Stefan H.J. Knackmuss, Erich Rajkovic, Uwe Reusch, Claudia Wall, and Eugene A. Zhukovsky, Affimed Therapeutics AG
The bi-specific antibody format is becoming the preferred antibody modality for current development projects in the pharmaceutical industry. This is due to an unsurpassed increase in functional activity relative to traditional mono-specific monoclonal antibodies, and a breakthrough in manufacturability enabled by novel designs. One such bi-specific format, the TandAb, produces antibodies that potently recruit immune effector cells to kill tumour cells, and TandAb antibodies are currently undergoing clinical trials for the treatment of hematological malignancies. Here we describe the selection process for the identification of stable and functional TandAbs and their manufacturability…
Bristol-Myers Squibb and Lonza expand biologics manufacturing agreement
Industry news / 31 October 2014 / Bristol-Myers Squibb Company
Bristol-Myers Squibb Company and Lonza today announced a multi-year expansion of their existing biologics manufacturing agreement. The contract expansion will include the production of commercial quantities of a second Bristol-Myers Squibb biologic medicine at Lonza’s mammalian manufacturing facility in Portsmouth, New Hampshire…