Manual Aseptic Processing: The Last Resort Or The Best Approach?

There are many pharmaceutical manufacturing applications where small batch sizes are common: specialty pharmaceuticals, high-value medicines, gene therapy, cell therapy, compounding, allergenic extracts, etc. There is also an increasing need for efficient aseptic filling capacity and techniques as the biotech industry and its innovative therapies expand in scope from cell therapies and CRISPR technologies. The increase in the number of Phase 1 and Phase 2 trials where only 50 to 100 patients are being treated greatly exacerbates the situation. In the past, standard vendor equipment offerings included automated filling lines with outputs of 50 or more containers per minute. However, complications arose when the total batch size (1,000, 100, or even 10 total pieces) was too small to justify an automated filling line. As processing demands have changed, many vendors now provide equipment for processing small batch sizes.