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What is process characterization?

Process characterization is an essential step in the commercialization of a new (biological) drug. For drug product commercialization, manufacturers must validate the drug’s manufacturing process. This ensures that the manufacturing process delivers consistently a quality product and that the patient is not at risk.
What is process characterization?
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News and Press Releases

Sphere Fluidics Closes a $4.8 million USD (£3.7 million) Funding Round

Cambridge, UK, 10 June 2019: Sphere Fluidics, a company commercializing single cell analysis systems underpinned by its patented picodroplet technology, announced today that it has closed an additional tranche of investment of $2.9 million (£2.2 million), securing a total of $4.8 million (£3.7 million) in investment. The funding will be used as working capital for the Company’s Cyto-Mine® Single Cell Analysis System, expansion of the UK facility and enable the doubling of personnel through the opening of a new US Sales Office and Demo Lab in California.
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White Papers

PhlexEarchive: The Right Solution for Electronic Archiving of TMF Content

Phlexglobal Ltd

Many sponsor organizations have already recognized the value of moving from paper to electronic Trial Master Files (eTMFs). But few sponsors have taken a more holistic approach to the TMF lifecycle and looked at the entire process from study start-up through archiving of the TMF in electronic format, also known as e-archiving. The recurring value of managing, tracking, maintaining and accessing electronic files should not stop at the point of archiving. All of the challenges of managing an active paper TMF carry through to a paper archive. All of the benefits of an electronic TMF also carry through to the electronic archive. As companies look to move their compliance assets to secure, long-term storage, it is important to consider ongoing compliance requirements, security, accessibility, efficiency and costs of archiving TMF content in a digital format.
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Industry Events

Clinical Trials Europe | Partnerships, Outsourcing, Operations & Technology

27 August - 21 November 2019, Barcelona, Spain

On 19-21 November 2019, the clinical trial community's most influential stakeholders will be meeting in Barcelona to discuss the evolving landscape, honing in on what it takes to harness true value from partnerships, outsourcing, operations, technology and early clinical development, for a faster, more efficient route to market.
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