Cell and Gene Therapy, Industrial Impact

The EU Clinical Trials Regulation − What You Need to Know

March 22, 2022

The EU Clinical
The Clinical Trials Regulation has retained some definitions and refined others. For example the definition of “clinical study”: “Any investigation in relation to humans intended: (a) to discover or verify the clinical, pharmacological or other pharmacodynamic. 

Spotlight

Sunesis Pharmaceuticals, Inc.

Sunesis is a clinical-stage biopharmaceutical company focused on the development and commercialization of new oncology therapeutics. With a passion to succeed, we give hope to cancer patients and their families by the development and commercialization of new oncology therapeutics.

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Liposomal and Nanoparticle Technology at Pfizer Melbourne

whitePaper | November 22, 2022

Specializing in oncology, anti-infective and complex formulations, Pfizer Melbourne provides end-to-end services from development through to commercial manufacture of sterile dosage forms.

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Vaccine and Biologics Development in an Emerging Post Pandemic Landscape

whitePaper | September 20, 2022

It is clear within the global health science industry that analytical biosafety testing and advances in developing scientific technologies will play an important role in drug development’s response to the next pandemic.

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Document quality control emerges as a discipline in its own right

whitePaper | November 19, 2022

Compiling a quality regulatory submission is a basic requirement for biopharmaceutical companies. Poor quality documents could lead to rejection of a regulatory application,

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Cell and Gene Therapy Hot Buttons Series

whitePaper | September 27, 2022

Cell and Gene Therapy (CAGT) activity has increased dramatically in recent decades, especially in Chimeric Antigen Receptor T-Cell (CAR-T) clinical trials and therapy registrations. The IQVIA CAGT Hot Buttons series covers basic concepts in CAGT for newcomers to this field.

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Biocontamination control in pharmaceutical production

whitePaper | November 11, 2022

Biocontamination refers to biological contamination of products by bacteria and/or fungi, as well as the toxic by-products of these microorganisms, such as endotoxin and mycotoxins from Gram-negative bacteria and fungi, respectively.

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Bold Goals for U.S. Biotechnology and Biomanufacturing

whitePaper | March 22, 2023

The world is on the cusp of an industrial revolution fueled by biotechnology and biomanufacturing. Emerging biological technologies are and will continue to transform the foundation of our physical world – everything from clothing, to plastics, to fuels, to concrete.

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Spotlight

Sunesis Pharmaceuticals, Inc.

Sunesis is a clinical-stage biopharmaceutical company focused on the development and commercialization of new oncology therapeutics. With a passion to succeed, we give hope to cancer patients and their families by the development and commercialization of new oncology therapeutics.

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