Abzena Expands Microbiology Laboratory Space

Communication between the manufacturing plant and retail stores. | Image Credit: © Cagkan - © Cagkan - stock.adobe.com

Abzena, an end-to-end contract development and manufacturing organization, is expanding its quality control testing capabilities at its San Diego, Calif., biologics development and current good manufacturing practice site, the company announced on Oct. 30, 2024. The expansion is part of the company’s strategy to meet market demand for quality testing. According to Abzena, the additional laboratory space will enhance its existing analytical toolkit for antibodies with microbiology release testing. The expansion will also improve scalability with advanced materials separation.

The standalone microbiology lab offers separate product testing from other areas of the facility, in alignment with industry and regulatory standards. Product microbiological testing is segregated from utility and environmental microbiological testing in order to minimize cross-contamination. Production capacity is optimized by the separation of high volumes of clinical materials, which results in yields up to 99%, according to the company. “This design methodology offers superior operational efficiency and improved scalability while minimizing overall ecological impact,” the company stated in a press release (1).

“This announcement comes at a very timely moment with World Quality Month quickly approaching. As an organization focused on quality excellence, increasing our QC [quality control] footprint is a testament to our commitment to continuous improvement and innovation,” said Troy Wright, senior vice-president and global head of Quality at Abzena, in the release. “This expansion provides even greater sample integrity in the management of our microbiological testing capabilities. We are now positioned to deliver faster results and better support for our customer network, ultimately providing quality and compliant products to patients around the world.”

In other Abzena news, the company announced on Sept. 26, 2024 that its mammalian cell line development platform, AbZelectPRO, reduces timelines by more than 30% and improves overall protein production levels. The platform can bridge from DNA to research cell bank in 10 weeks and produces up to 8 g/L of high-performing titres before process development, according to the company (2).

Abzena recently attended CPHI Milan in October 2024, and Pharmaceutical Technology® Europe caught up with Nicolas Camper, senior director—Bioconjugation Chemistry at Abzena, to talk about advancements in conjugation and linker technologies in antibody-drug conjugate (ADC) development and manufacturing (3).

“There have been a lot of new developments in terms of conjugation and linker technologies. There is a definitive move towards site-specific conjugation technologies and away from stochastic conjugation approaches that allows [us] to prepare better-defined antibiotic-[drug] conjugates,” Camper said in the interview.

Another new development that has been observed over the past few years is that linkers are becoming more sophisticated. “Quite often, when you conjugate cytotoxic drugs, they are quite hydrophobic, and that can impact the performance of your ADC. So, there has been a lot of effort put into developing more hydrophilic linkers,” Camper noted.

Watch the full video on PharmTech.com.

References

1. Abzena. Abzena Announces Major Expansion in Microbiology Laboratory Space in Suppor of Biologic Manufacturing. Press Release. Oct. 30, 2024.
2. Abzena. AbZelectPRO Enables Biopharma Customers to Reach their Research Cell Bank in 10 weeks with 8g/L. Press Release. Sept. 26, 2024.
3. Mirasol, F. CPHI Milan 2024: New Developments in ADC Technologies. PharmTech.com. Oct. 10, 2024.