Cell and Gene Therapy

Gene and cell therapy analytical and development methods

April 20, 2023

Gene and cell therapy
In the three decades that have passed since the approval of the first gene therapy in 1990, these revolutionary medicines have changed the lives of patients all over the world1.

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BioStorage Technologies, Inc.

BioStorage Technologies, Inc. is the premier, global provider of comprehensive sample management solutions for the bioscience industry. Offering flexible onsite, offsite and hybrid models for the smartsourcing of research assets, BioStorage Technologies provides a complete life-cycle of sample management solutions.

OTHER WHITEPAPERS
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Biosimilars – commercial best practices in the age of sustainability

whitePaper | November 4, 2019

Revenues from biologics increased by 70% from 2011 to 2016. Biologics account for 20-22% of total pharmaceutical spending. IQVIA estimates US biologics spending will reach $320bn by 2023

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T Cell Expansion in Small Scale Bioreactors

whitePaper | October 28, 2022

Adoptive cell therapy (ACT), a branch of immunotherapy, offers a promising treatment for chronic viral infections and malignant diseases such as cancer [1]. This innovative approach involves the autologous or allogenic transplant of immune cells into the patient’s body.

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Benefit-Risk Considerations for Product Quality Assessments; Guidance for Industry; DRAFT GUIDANCE

whitePaper | May 10, 2022

This guidance describes the benefit-risk principles applied by FDA when conducting product quality-related assessments of chemistry, manufacturing, and controls (CMC)2 19 information 20 submitted for FDA assessment as part of original new drug applications (NDAs) under section

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Bispecific Antibodies Unleashed from Mechanisms to Manufacturing and Strategic Collaboration for Effective Precision Immunotherapy

whitePaper | July 13, 2023

Advances in disease biology have led to the burgeoning development of bispecific antibodies (BsAbs), which are synthetic proteins capable of targeting two discrete epitopes from different antigens. Their bispecific functionality offers promising therapeutic potential such that their applicability to a variety of therapies is being explored.

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Eliminate Noisy Oxygen Measurements in Bioreactors

whitePaper | March 27, 2023

Controlling the dissolved oxygen level in fermentation vessels and bioreactors is vital to maximizing production yield and ensuring high end-product quality.

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Cell and Gene Therapy Clinical Trials

whitePaper | November 8, 2022

Using experienced-based best practices and documented tools, ICON has conducted over 63 CGT trials across multiple therapeutic areas from haematology-oncology torare and orphan diseases.

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Spotlight

BioStorage Technologies, Inc.

BioStorage Technologies, Inc. is the premier, global provider of comprehensive sample management solutions for the bioscience industry. Offering flexible onsite, offsite and hybrid models for the smartsourcing of research assets, BioStorage Technologies provides a complete life-cycle of sample management solutions.

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