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Biologics - Articles and news items

cerament g bone substitute

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

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…

biologics

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 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 - Chimera Biotec - April 2016

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…

Webinar-Feature

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

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…

Subvisible particle sizing and counting

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

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…

biosimilar

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-feature

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…

BMS and Lonza expand biologics manufacturing agreement

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…

 

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