Biotherapeutics are currently the fastest growing group of pharmaceuticals, being a treatment option for a variety of chronic and sometimes life-threatening conditions. They represent a diverse group of biological products that broadly encompasses nucleic acids, proteins, whole cells, viral particles, and vaccines. In the recent years, great strides have been made toward the development of safer and more effective biotherapeutics, as well as in the adoption of cost-effective, more efficient, and streamlined manufacturing processes. This trend is expected to accelerate in the forthcoming years, as emerging fields related to advanced therapies or personalized medicine mature. Despite these progresses, there are still knowledge gaps across all stages of development, as well as technical and regulatory hurdles that can thwart the approval process of these products.

This special issue invites original research and review articles reporting on the recent developments and application of biotherapeutics.

Potential topics include, but are not limited to:

• Nucleic-acid therapeutics (e.g., plasmid DNA, antisense technology, aptamers, siRNAs/miRNAs, CRISPRs)
• Protein-based therapeutics (e.g., antibodies, cytokines, interferons, growth hormones, enzymes)
• Vaccine technologies (vaccines, vectors, adjuvants)
• Vector design and gene delivery
• Advanced-cell therapeutics (e.g., primary cells, adult stem cells, embryonic stem cells, induced pluripotent stem cells)
• Cell engineering to improve biomanufacturability
• Biomanufacturing, up-/downstream processing and storage
• Process analytical technology (PAT) and Quality by Design (QbyD)
• Quality control and safety issues
• Regulatory compliance and intellectual property
• Biosimilars
• Clinical testing