Early engagement and regulatory considerationsfor biotech

May 10, 2022

Biotechnology companies are at the epicenter
of innovative drug development, with discoveries
spanning from small molecules, large molecules,
and biologics to genomic medicines

Spotlight

Innova Biosciences Ltd

Innova Biosciences, based in Cambridge, UK, specialises in providing highly effective solutions for all your bioconjugation challenges. Problems such as poor yield, batch to batch variation and low sensitivity are all overcome by using our core labelling technologies of Lightning-Link®, InnovaCoat® and Thunder-Link®.

OTHER WHITEPAPERS

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

Lipid Nanoparticle and Liposome

whitePaper | September 12, 2022

Lipid nanoparticles (LNPs) and liposomes are variations of lipid-based drug carriers differing in their internal structure.

WHO considerations on Regulatory Convergence of Cell and Gene Therapy Products

whitePaper | December 16, 2021

Use of cells, tissues, and gene therapy products for the treatment of diseases or 72 physiological conditions has become of wide interest due to their potential to address serious 73 unmet medical needs.

Multi-Attribute Methods for Biopharmaceutical Analysis

whitePaper | December 5, 2022

The adoption of LC-MS-based multi-attribute method (MAM) analysis for routine monitoring of biotherapeutic variation has progressed greatly over the last five years.

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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