Automation drives Zenith's US expansion
- Keeping costs down and improving consistency between batches are key drivers behind automation, but this can be challenging in biotech manufacturing, where changes can have an impact on the final product.
- Companies like Zenith Technologies, which provide manufacturing expertise, allow companies to outsource automation, serialization and process control.
- Zenith Technologies has responded to increased demand by recently opening two new offices in the US West Coast.
Automation, serialization and process control are important drivers in drug manufacturing, as companies fight to keep down costs and keep up with regulatory requirements that ensure drug safety and protect against diversion and counterfeiting. As it’s not always easy to manage this in house, the market for outsourcing solutions is growing.
One company that has seen increased demand for its services is manufacturing software solutions provider Zenith Technologies. First founded in Cork in Ireland in 1998, Zenith has grown throughout Europe, Asia and the U.S.
Last week Zenith opened two new offices on the West Coast to manage demand for automation, process control and serialization technology support services in the growing biotech industry in California. “We are looking forward to bolstering our US presence with the opening of these two new sites as it means we can provide complete coverage of service in the US from coast to coast," said U.S. sales manager Mike Smith in a release on August 19.
One of the factors behind this growth, according comments from Smith given in an interview with In-Pharma Technologist, is the shift from small molecule to biologics-based therapeutics. The greater focus on biologics requires companies to convert existing facilities designed for single drugs into multi-drug production facilities. Other factors include increasing capacity and consistency, and reducing the time to release batch records.
Changing production processes in biotech can be challenging, as the smallest change can have an impact on the safety and efficacy of protein drugs, by changing how they fold or altering the patterns of glycosylation. This obviously makes regulators wary.
However, Smith believes the FDA is becoming more accepting of automation, and sees the value in reducing human intervention in most cases.
The FDA has been pushing drugmakers to transition away from traditional batch production—which necessarily involve greater human intervention between steps—and adopt continuous manufacturing on a more widespread basis.
Unlike batch processing, continuous manufacturing feeds raw materials for solid-dose products through a continuous, nonstop process.
In April, the agency approved the first switch from batch to continuous manufacturing, giving the green light to Janssen for production of its HIV drug Prezista. And other drugmakers, including Vertex and Eli Lilly, are working to build continuous processes into production from the start. Eli Lilly, for example, said earlier this year it would invest €35 million to build a continuous API manufacturing site at its Kinsale plant in Ireland.
- In-Pharma Technologist Cost pressures turning pharma towards automation tech, says Zenith
- BioPharma Dive FDA advocates for adoption of speedier drug manufacturing technique
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