ACROBiosystems  has begun to narrow its focus into helping accelerate the process between preclinical, clinical and commercialization. The new strategic focus has culminated in the investment and emphasis on GMP-grade products and services, alongside the launch of their new ClinMax product line which encompasses preclinical and clinical pathology and technical service platforms.

To better meet the needs of their customers for safe, reliable, and high-quality raw materials for clinical manufacturing, the company established a strict GMP-level quality management system in accordance with international standards and regulatory guidelines globally, including the FDA, EMA, and NMPA. The quality management system is also in compliance with ISO9001/13485 standards, to help set and ensure a high standard for all products from ACROBiosystems.

In a statement, the company said that the substantial effort and commitment to providing high-quality products is demonstrated by the investment in the development of a GMP-grade production facility. ACROBiosystems’ GMP facility, expected to be fully operational in 2024, will have 180,000 sq.-ft. available for manufacturing their current GMP product lineup including cytokines, enzymes, antibodies, and cell activation beads to accelerate the development of cell therapies globally.

However, according to the company, GMP-grade products are only a single component of the entire therapeutic manufacturing process. Depending on the development stage of each therapeutic, whether it is in discovery, CMC, or even entering the clinical stage, GMP-grade materials are not always required.

To offer drug developers a more cost-effective option before entering GMP-grade therapy manufacturing, ACROBiosystems offers premium-grade reagents that have the same performance as its GMP counterpart, enabling a simple, streamlined transition from pre-clinical development into clinical research.

“As more of our customer’s projects enter into the clinical phase, there is a shortage of clinical-level approaches and key reagents to support its translation into commercialization, especially when we look at more novel, innovative therapeutic drugs,” said Mike Chen, Chairman and CEO of ACROBiosystems. “Investments and capital have begun to refocus its direction, backing less homogenous early-stage projects, and transitioning it into more successful clinical-stage projects. With the sudden influx in capital and rush towards innovative clinical research, customers require a wider variety and offerings of clinical-stage products and services.”

Chen added: “After wrapping up our first strategic development phase, we have established a deep relationship and cooperation with our customers across the industry while significantly increasing and testing the capabilities of our development team within an industry-context. With this success, we begin to enter the second phase of our strategic development which is to focus on more clinically relevant applications and scale-up our manufacturing capabilities to support a large-scale, high-quality, and more localized supply chain response to assist the needs of our clinical customers.”

Regarding the future, ACROBiosystems said that it seeks to build the world’s largest GMP reagent production platform to support an extensive catalog of reagents and raw materials for CMC production into clinical research for the next generation of biopharmaceuticals.

Meanwhile, it continues to support the manufacturing and development of diagnostic products to support preclinical, clinical, and commercialization efforts to assist its customers and their therapies.