Minister sounds an optimistic note
Bioscience Journal asked Life Sciences Minister George Freeman to assess the progress being made.
As the UK’s first ever minister for Life Sciences, I am determined to ensure that Britain remains the best place in...
Bolder Faster Stronger, how far can we go in the battle against illness?
Earlier this year, Austrian researchers came up with the startling suggestion that life should be regarded as beginning at sixty five.
Researchers at the International Institute for Applied Systems Analysis examined predicted ageing rates up...
Understanding climate change and infectious disease: is the one health movement enough?
1 University of Reading, School of Agriculture, Policy and Development, Livestock Development Group
1&2 University of Reading, Walker Institute for Climate Research
In the coming decades, climate change is predicted to produce a range of direct...
Climate Change and the challenges facing mankind
Climate change is one of the biggest challenges facing mankind. Always has been, always will be, and that means that big changes lie ahead.
Many of those changes will impact on the work of scientists...
Bioscience Expertise, Training, and Equipment Access
Bioscience Technology is moving so quickly that radical approaches have to be taken to ensure researchers have sustainable access to cutting-edge expertise, equipment and training.
The Bioscience Technology Facility is an exemplar which proves that...
Blocking escape route offers hope to cancer patients
A new drug that blocks cancer’s escape route from chemotherapy could be used to treat lung and pancreatic cancers.
Scientists in human cancer cells and in mice have shown that the drug boosts the effectiveness...
Vericel: Improving multicellular therapy through advanced manufacturing
Founded in 1989, Vericel (formerly Aastrom Biosciences) is dedicated to the development of patient-specific expanded cellular therapies for use in the treatment of patients with severe diseases and conditions.
The company currently markets two cell...
Product Characterization for Cell Therapy GMP Manufacturing
The specifications, QC and release testing of cell therapy products can make the difference between success and failure
Stefanos Theoharis, Suncana Kern and Christine Guenther, apceth GmbH & Co. KG. All manufactured products require measurable parameters,...
Replace FBS with Human Platelet Lysate
The manufacture of clinical-grade cellular products often requires ex vivo culture and expansion of human cells.
Fetal bovine serum (FBS) is frequently used as a supplement to basal cell culture media during expansion; however, its...
Growing the UK cell and gene therapy industry
Cell and gene therapies are at the very cutting-edge of medical research and the creation of the Cell Therapy Catapult’s state-of-the-art £55 million manufacturing centre at the Stevenage Bioscience Catalyst, will help Britain be...
Critical Factor for Industrializing Cell Therapies:
Quality Attributes and Quality Assurance of the Manufacturing Raw Materials
Slowly but progressively more Advanced Therapy Medicinal Products (ATMP), including Cell Therapy Products, are reaching the market and a significant number are getting closer to...
The Age of Cell Therapy Industry that takes advantage of pioneering research
For a cutting-edge technology, cell therapy has a surprisingly long history. Indeed, the idea of injecting living cells into a patient originated in the nineteenth century.
Although scientists’ early rudimentary attempts did not really work,...
Biosimilars – What are the critical regulatory milestones during development and registration?
The ever increasing complexity of regulations and drug approval pathways has converted regulatory intelligence into one of the key assets during any kind of drug development.
This situation is even more pronounced in the case...
Looking for a partner for your biosimilar clinical trial?
BioKinetic Europe is one of the UK’s leading early phase clinical research organizations with experience in over 400 clinical trials. Our Phase I portfolio comprises BE/BA studies, SAD/MAD/Proof of Concept, TQTc, DDI, vaccine and...
Key success factors for biosimilars
Global regulatory pathways for biosimilar development are continually evolving. Many countries throughout the world have established legal and regulatory pathways which allow development of biosimilar products.
The European Union (EU) was the first region in...
Development of a Biosimilar
By Catriona Thomson, PhD
Associate Director of BioAnalytical Technical Services
Global sales of the top seven biologics in 2014 were in excess of US$60 billion and of these molecules, six were monoclonal antibodies1 that have...