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| home > ebr > Summer 2017 |
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 PUBLICATIONS |
European Biopharmaceutical Review |
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Editor's Letter
Editor’s Letter
Offering an overview of this issue, EBR Editor Dr Deborah O’Neil covers the problems facing creators of rare disease treatments and the ongoing debate surrounding genetic engineering.
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Therapies for Blood Cells
Upcycling Genomics
Dr Franziska C Ruf at SIRION Biotech suggests that advances in the gene therapy sector, using hematopoietic and stem cells, will lead to a cure to heritable diseases, such as asthma, arthritis and cancer.
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Oligonucleotides and Separation
Complex Characters
Characterising oligonucleotides is a process fraught with analytical challenges, but it is showing positive results in clinical trials and continues to gain traction within biopharma organisations, says Jon S Kauffman at Eurofins Lancaster Laboratories. |
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Achievements in Protein Manufacture
What about Pichia?
Advances that remedy current recombinant protein expression problems are exposing one yeast as a more efficient system for manufacturing therapeutics, reveal Thomas Purkarthofer, Iskandar Dib and Evelyn Trummer-Gödl at VTU Technology.
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Pharmaceutical Stability
Protein Productivity
Lisa Newey-Keane at Malvern Instruments proposes that analytical tools for evaluating stability, such as the latest DSC instruments, could help scientists gather important information with greater efficiency and accelerate liquid formulation.
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Orphan Disease Legislation
Acting Up
The Orphan Drug Act might require updating, stress Matthew Weinberg and Emily Krulewitz at The Weinberg Group, as its efficacy continues to be debated and a lack of clear-cut distinctions are allowing some to cheat the system.
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Q&A: Rare Disease Dilemma
Sustainable Solutions
In this interview, Hege Hellström at Sobi EMENAR and Neil Dugdale at Sobi UK and RoI explain why a long-term approach to the treatment of rare diseases is key and discuss why the company advocates collaboration with stakeholders.
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Gene-Editing
Cut and Paste
The science fiction-like concept of gene-editing faces a barrage of ethical concern from parties across the industry as well as wider fields, but Jimmy Muchechetere at Investec Wealth & Investment believes it is an opportunity that could transform pharma.
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Focus on Pharmacovigilance
Strategic Advantage
ProductLife Group’s Cheryl Key determines that maintaining investment in pharmacovigilance processes has become more significant following the escalation of globalisation and resulting heightened business demands.
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In Brief
In Your Genes
EBR’s Industry Advisor Emile Bellott explores the recent FDA approval of direct-to-consumer genetic testing for a variety of diseases.
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Biosimilars Development
Revolution or Evolution?
The pharma industry does not exist in a vacuum and, as such, the economic and political climate have a substantial impact on the market and manufacturers of biosimilars, according to Guillaume Plane at Merck.
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Mature Products
Organisation Optimisation
David Balderson at Sciformix Corporation acknowledges the opportunities outsourcing offers, as he points out that effectively managing an already established portfolio of products is just as critical as the development of new ones.
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Comparability Analysis
Dissecting Structures
BioPharmaSpec's Dr MI Millichip and Dr AJ Reason argue that biosimilarity assessment guidelines are not sufficiently precise regarding determination of higher order structure. It is necessary for these tests to go hand-in-hand with primary structure characterisation.
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Biologic Classification
QbD in Action
Although it can introduce further associated difficulties, Simon Cubbon at Thermo Fisher Scientific advocates the use of high-resolution mass spectrometry within QC and lot release for routine biopharma characterisation.
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Personalised Therapeutics
Hidden Treasures
New small molecule biomarkers, which can be discovered through mass spectrometry, could enable a clearer understanding of the precise impacts of medicine and allow drugs to more effectively treat diseases, according to Professor Hermann Mascher at pharm-analyt Labor.
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Bioanalytical Technology
Teething Problems
Richard Hucker, Ian James, Scott Vincent and Carl Watson at A4P Consulting remind us that key decisions need to be made from science, operational and business perspectives throughout the drug development process and the transition to clinical activities.
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News and Press Releases |
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Northway Biotechpharma and Hansa Biopharma initiate a new Contract Development and Manufacturing project in immunological diseases
Vilnius, Lithuania, and Lund, Sweden - December 20th, 2019 – Northway Biotechpharma, a leading biopharmaceutical Contract Development and Manufacturing Organization (CDMO), and Hansa Biopharma, the leader in immunomodulatory enzyme technology for rare IgG-mediated diseases, today announced a new service agreement to develop the next generation of IgG cleaving enzymes.
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White Papers |
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Points to Consider When Developing a TMF (Trial Master File) Strategy
Phlexglobal Ltd
Many organizations are currently outsourcing clinical trial activities to one or more contract research organizations (CROs). This strategy enables companies to leverage specialized expertise and take advantage of flexible resourcing throughout the conduct of a clinical trial. Outsourcing minimizes the costs of recruiting experts, building a team and maintaining an infrastructure. However, it can also add complexity as the organization looks to meets its compliance obligations regarding clinical trial documentation.
The documentation referred to in Article 15(5) of Directive 2001/20/EC as the trial master file shall consist of essential documents, which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated.1 This essential study specific documentation is also known as the TMF. As organizations try to minimize their reliance on paper files, the electronic TMF (eTMF) has emerged. A current industry initiative to standardize the organization of this content is known as the TMF Reference Model. This model is helping standardization efforts across paper and electronic systems.
As companies implement outsourcing strategies, CROs and sponsor organizations look for a common foundation on which to build their TMF capabilities. The following paper outlines some of the challenges organizations face when outsourcing clinical trial activities to multiple contract research organizations and a strategy to facilitate partnering and management of trial information between sponsors and CROs.
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Industry Events |
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Clinical Trial Supply Europe
11-12 March 2020, Madrid, Spain
The 21st annual edition promises to grow on the success of 2019’s excellent conference which saw delegates from Europe’s largest pharmaceutical companies and biotech innovators come together to discuss, debate and unpack the latest trends in clinical supply chain innovation. 2020 will offer delegates the opportunity to address the growing need for agility within the supply chain in response to increasingly complex trial demands. With a stream dedicated to supply operations and another to innovative uses of technology in the supply chain, delegates will get the chance to gain practical take-aways that they can apply to their own studies.
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