Biotherapuetics are predicted to take a major share of drug market in the coming decades, of which proteins and vaccines constitute important part. Unlike small molecule drug compounds, biomacromolecules pose tougher challenges for manufacture, storage and stability at the high concentrations required for therapeutic use. Highlights of bioprocess, down stream processing, analytical characterization along with a detailed account of formulation and development of monoclonal antibody (mAb) will be covered in this presentation. Technical hurdles in stability testing, protein aggregation, filling and packaging, excipient selection, and drug product characterization in liquid and lyophilized forms will be discussed. A brief account of development and delivery challenges of fusion proteins and vaccines will be included for comparison