US-based Lentigen uses its proprietary lentiviral gene delivery technology in biologics manufacturing to reduce cost, time and risks. As Lentigen wants to further reduce operational costs and reduce time-to-market, it has teamed up with Wave to use its single-use bioreactor system to produce lentiviral vectors.
The use of disposable equipment in biologic drugs production is increasing, as the benefits of reduced contamination risks and time savings, mainly by eliminating the need for cleaning and sterilisation between batches, become clear.
Research conducted by disposable equipment specialist Stedim, suggests that swapping from stainless steel to single-use technologies would cut costs by 41 per cent. But, could increase to 50 or 60 per cent if there is a complete switch to disposable bioreactors.
The analysis was based on a €22.6m facility model, with a 41 per cent reduction on the €38.5 million capital investment for a stainless steel unit. The cost of process equipment was cut to €4.1m from €7.1m, while other savings accrued from process installation (€4.5m versus €8.9m) and building costs (€5.7m versus € 7.3m), the latter mainly from the absence of fixed piping and fewer electrical sources.
"The demand for disposables and single-use technologies has been increasing at an aggressive pace year-on-year," Daniella Kranjac, Wave Biotech VP of sales and marketing, told In-PharmaTechnologist.com.
"Single-use technologies are now mainstream and accepted in the biopharma industry as alternatives to the conventional, labour-intensive stainless steel tank systems that dominated the field."
Wave will provide Lentigen with bioreactor hardware, instrumentation, Cellbag disposable bioreactors and ancillary products, such as mixers, tube sealing and fusing devices.
The challenges for gene therapy are to develop vectors -vehicles that deliver genetic material into cells - that deliver genes efficiently to human cells without toxicity. Lentiviral vectors deliver genes or RNA interference (RNAi) into cells with up to 100 per cent efficiency and stability, according to Lentigen.
"This is one of the many partnerships that we are forging to develop our lentiviral vector platform. We're excited to have Wave Biotech as one of our partners," said Boro Dropulic, CEO of Lentigen.