USE OF NEXT GENERATION PROTEIN THERAPEUTICS OVER TRADITIONAL MONOCLONAL ANTIBODIES AND DIFFERENT APPROACHES
Available now on knect365.com. Click the link to access the whitepaper.
Increasingly next generation proteins are being used over traditional monoclonal antibodies. This exclusive whitepaper explores the different approaches, competitive advantages and challenges of these next gen therapeutics.
According to BIS Research and Research and Markets the worldwide biologics drug discovery market is predicted to increase from USD $8.1 billion in 2015 to USD $22.7 billion by 2025. The biologics discovery growth rate is predicted to be faster than in the dominant small molecule discovery sector. Monoclonal antibodies are expected to make up just under half of the biologics discovery market in 2025. Engineered or recombinant proteins such as next generation protein therapeutics are expected to contribute 3 billion to the market in 2025.
The dominance of monoclonal antibodies (mAbs) are due to several factors including their efficacy brought about by their high specificity allowing selective targeting; long half-life compared to small molecules due to the presence of the Fc region that allows the antibodies to engage the FcRn mediated salvage; and the ability to activate immunemediated effector functions, e.g. antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC), via the interaction of Fc portion with Fc-gamma receptors. Promoting their adoption, Mabs have proven useful in the rapidly expanding immune-oncology field which has led to a proliferation of antibody products through “copy-cat” development. Mabs, however have important disadvantages such as cost of goods that next generation protein therapeutics do not suffer from.
Next generation protein therapeutics can be considered antibody mimetics as each protein therapeutic is composed of a constant region, which stabilizes the overall protein folding, and variable regions that facilitate its target binding. The specificities of these next generation proteins variable regions can be directed in vitro, contrasting antibodies and antibody fragments which require the immunisation of animals to generate.
PROGRESS TOWARD COMMERCIAL SCALE AND EFFICIENCY IN CELL THERAPY BIOPROCESSING
Available in the October 2016 Supplement of BioProcess International:
Cell and gene therapy is an extremely promising and growing medical technology sector with 631 ongoing clinical trials at the end of 2015. It is applicable to oncology, cardiovascular disease, infectious diseases and other diseases. The merit of cell and gene therapy has been demonstrated by FDA approvals, however commercialisation can prove a high hurdle that can trip up even approved therapeutics such as Dendreon’s Provenge autologous cell therapy. There are however steps that can be taken to reduce the risk associated with commercialisation that companies with a cell and gene therapy portfolio should consider. This whitepaper discusses practical measures to improve the chances of commercial success:
- Characterization and Comparability Risk reduction through Quality by Design (QbD)
- Improving efficiency and reducing costs in development and production
- Novel analytical technologies and methodologies
- Ensuring successful process scale up and transfer
- Progress towards the industrialization of cell and gene therapies through modularisation