Sterling Pharma Solutions is significantly expanding its GMP antibody-drug conjugate (ADC) manufacturing capacity with a £10 million investment aimed at doubling the current capacity at its Deeside, UK site. This expansion involves commissioning a new 2,300-square-foot suite, which includes a 1,400-square-foot Grade C cleanroom to handle clinical-scale manufacturing using reactors up to 500 liters. By integrating flexible and hard containment technologies, the upgraded suite will manage highly potent molecules with exposure limits as low as 0.01 micrograms per cubic meter, ensuring safe handling and operational efficiency.
Key themes emerging from this development include a strong focus on increasing manufacturing capacity and flexibility to meet the growing demand for ADC development. The implementation of single-use bioreactors is highlighted as critical for eliminating cross-contamination and enhancing process efficiency. Furthermore, existing ancillary GMP facilities for buffer and reagent preparation, waste disposal, water for injection generation, and quality control laboratories are set to support the new suite, demonstrating a comprehensive approach to operational support.
Addressing the Bottleneck in ADC Development
Sterling Pharma Solutions is significantly boosting its GMP antibody-drug conjugate (ADC) manufacturing capacity with a £10 million investment. This initiative aims to double the current output at its Deeside, UK facility. The expansion will see the introduction of a new 2,300-square-foot suite, featuring a 1,400-square-foot Grade C cleanroom designed for clinical-scale manufacturing using reactors up to 500 liters. The upgraded suite will integrate flexible and hard containment technologies to manage highly potent compounds with exposure limits as low as 0.01 micrograms per cubic meter, ensuring safe operations and efficiency.
Key aspects of this expansion include a commitment to enhanced manufacturing capacity and adaptability to meet the rising demand for ADC development. The deployment of single-use bioreactors is noteworthy for its role in preventing cross-contamination and improving process efficiency. Supporting this new suite are existing ancillary GMP facilities for buffer and reagent preparation, waste disposal, water for injection generation, and quality control labs, highlighting a comprehensive approach to operational support.
