Expertise And Efficiency In Small-Volume Batch Manufacturing

By Alex Cravens, Singota Solutions

Demand for small-batch drug product (DP) manufacturing — from formulation to sterile fill/finish — is rising as drugs for precision medicine and large-molecule biologics gain in prominence. However, traditional fill/finish providers may consider small batch sizes as lacking economic feasibility. They may offer only rigid, far-in-the-future manufacturing dates or lack the equipment, expertise, and/or manufacturing slots to produce small batches.

Singota has distinguished itself as an end-to-end, small-batch parenteral manufacturing CDMO that does not just accommodate modest volumes but welcomes and specializes in them. While we typically produce GMP batches of less-than 10,000 units, we understand that batch size is specific based on various customer needs, including total amount for clinical testing, QC testing, retained samples, etc. Singota can help guide small or emerging developers through manufacturing, documentation, QA, or regulatory matters.

Additionally, while drug developers often source their own raw materials early in development, they require a more robust supply chain as they push into clinical trials. Singota stands out for its aptitude in end-to-end supply chain management and can guide customers through all its elements, including cold chain storage, shipping conditions, labeling, and optimal packaging. Some clients seek only manufacturing, some only supply chain, but many take advantage of our capability in both.