OLIGONUCLEOTIDE & PEPTIDE WHITEPAPERS

Research and innovation in drug delivery systems is a rapidly evolving field, especially as the scope of drugs now encompasses not only small molecule drugs but also biological macromolecules including DNA, RNA, proteins and peptides.

As a field that has seen fast paced expansion as far as research and development is concerned, it encounters many challenges in terms of development of delivery systems catering to these novel drug entities. The challenges are numerous-from the choice of the perfect delivery system and formulations that are specific for each of the macromolecular subtypes.

This whitepaper talks about the challenges, strategies and innovations when it comes to drug delivery of oligonucleotides, peptides, RNA, mRNA and CRISPR.

One of the greatest challenges when is comes to drug approval is the Chemistry, Manufacturing, and Control (CMC) of quality processes.

Some of these challenges include determining critical quality attributes and critical process parameters, low transduction efficiency, assessment of potency, assurance of product sterility, process validation, stability, and production at multiple manufacturing sites.

This whitepaper that highlights CMC approaches to accelerate peptide, oligonucleotide and mRNA therapeutic development.

Synthetic peptide vaccines are a nascent but highly promising therapeutic class. The field unites cancer biology and infectious disease treatment principles. There is, however, a key difference, a cancer vaccine is not prophylactic. Even though infectious disease prophylactic vaccines, such as against HPV, can prevent cancer, personalized cancer vaccines are an active treatment of an existing tumor.

This whitepaper focuses on peptide cancer vaccines, although infectious disease vaccines are also touched upon. Several considerations are important such as the peptide selection, and strategies to overcome loss of MHC. Personalization opens up regulatory challenges and these are also discussed.

This whitepaper looks at the challenges and opportunities facing the peptide and oligonucleotide therapeutics industry in partnering, business development and commercialization strategies, using a number of case studies. The drug space is enormous and the fields of peptide and oligo development dynamic, with both technologies converging upon intracellular targets, as well as traditional extracellular ones, making the possibilities for collaboration, licensing and investment, large.

In the last decade, the costs for developing new medicines has more than doubled. The patient-centric drug considerations and health care demands, pressure the industry to speed up global access to treatments with associated costs. As such, regulations and policy also need to evolve rapidly, so that innovation is not slowed down by bureaucratic obstacles, which could endanger getting and maintaining licenses worldwide.