NEWARK, Del., March 30, 2023 /PRNewswire/ — With more than 10 years of experience in protein development, ACROBiosystems has continuously demonstrated its strength in developing products and services throughout the entire drug development process. As such, ACROBiosystems has begun to narrow its focus into helping accelerate the process between preclinical, clinical and commercialization. This new strategic focus has culminated in the investment and emphasis on GMP-grade products and services, alongside the launch of their new ClinMaxTM product line which encompasses preclinical and clinical pathology and technical service platforms. With this new product development focus, ACROBiosystems continues to surprise and bring new solutions to the pharmaceutical industry that assist in therapeutic manufacturing and its subsequent commercialization.
GMP-grade quality management to uphold the strict raw material standards throughout preclinical and clinical cell therapy manufacturing
To better meet the needs of their customers for safe, reliable, and high-quality raw materials for clinical manufacturing, ACROBiosystems has 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.
The establishment of a GMP quality management system is no easy task: requiring a significant investment in human and material resources. 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, with over 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, 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.
Beyond its products, ACROBiosystems also offers a complete range of services including custom GMP-grade raw material development. Within this service, ACROBiosystems ensures that it strictly complies with the various regulatory requirements for raw (also termed ancillary) materials for cell therapy manufacturing globally. This includes various quality management systems that include its advanced protein expression technology, process controls, quality controls, and comprehensive documentation trails. Services for each manufacturing step is also available, starting from its targeted protein design integrating both structure and application, before moving into gene synthesis, vector construction, protein expression, and scale-up / scale-out production services.
At the same time, ACROBiosystems is also experienced in its global distribution with its established supply chains across the globe. This ensures efficient import and export approvals, inspection, custom clearances, as well as transit logistics in a wide variety of modes; all to support clinical research across the globe.
Operated by its subsidiary, ACROBiosystems emphasizes the importance to its preclinical and clinical-focused strategy
ACRODiagnostics Inc. is a translational medicine biotechnology company in the ACROBiosystems group. As a global biotech company, ACRODiagnostics is focused on providing analytical reagents and custom services for the biopharmaceutical and clinical diagnostics industries. To help accelerate the clinical translation and commercialization of novel therapies, ACRODiagnostics has established a comprehensive pathology assay development and project teams, where combined, have more than 10 years of experience in the development of in vitro and companion diagnostic kits, alongside CRO services. This also includes the development and validation of diagnostic reagents for anatomical, intravascular, and molecular pathologies. To ensure the effective establishment and implementation of pathological assays, they also practice good laboratory management under CAP and ISO15189 quality guidelines.
This practice also extends to the ClinMaxTM product line, which includes both biological and clinical sample analytical kits. With a product development team rich in experience in designing, developing, and validating kits for various platforms, all assays offered by ACRODiagnostics and by extension, ClinMaxTM, are low-risk and high-quality despite the complex and variable clinical scenarios. By sourcing raw materials from ACROBiosystems’ extensive quality management system, developing them in an IVD/ISO13485 quality management system, and manufacturing them under strict GMP-compliant environments, kits and assays are ensured to be of high-quality and stable under various conditions.
Empowering their customers to overcome industry challenges with products focused on integrating structure and application
Despite the new product development focus onto clinical research, the core mission of ACROBiosystems remains unchanged – delivering products to accelerate the drug development process. Starting with the customer needs and forming the product development process around this requirement is how ACROBiosystems was founded and will continue to do so. At this stage, refocusing their development into the clinical stage stems from two reasons.
The first of which, comes from Mike Chen, Chairman and CEO of ACROBiosystems, stating:
"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." He also mentions the redistribution of industry capital and investments within novel therapeutics where, "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."
This is good news for ACROBiosystems, where with over ten years of development, it has established itself as a solid brand and front-runner with the capabilities to address the needs of clinical-stage projects. This move away from academic research and early research and development projects is also another reflection of the next step for ACROBiosystems.
"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." reveals Mike Chen.
With regard to the future, ACROBiosystems 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.
About ACROBiosystems Inc.
ACROBiosystems Group (SZ.301080), founded in 2010 and listed in 2021, is a biotechnology company aimed at being a cornerstone of the global biopharmaceutical and health industries by providing products and business models innovation. The company spans across the globe and maintains offices, R&D centers, and production bases in 12 different cities within the United States, Switzerland, England and Germany. ACROBiosystems Group has established numerous long-term and stable partnerships with the world’s top pharmaceutical enterprises, including Pfizer, Novartis, and Johnson & Johnson, and numerous well-known academic institutes. The company comprises of several subsidiaries such as ACROBiosystems, bioSeedin, Condense Capital, and ACRODiagnostics.
ACROBiosystems’ brands include FLAG, Star Staining, ViruStop, Aneuro, ComboX, GENPower, and many others. Its main products and services are recombinant proteins, kits, antibodies, scientific services, and other related products. ACROBiosystems employs a strict quality control system for its products that are used in biopharmaceutical research and development, production, and clinical application. This includes targeted discovery and validation, candidate drug screening/optimization, CMC development and pilot production, preclinical research, clinical trials, commercial production, and clinical application of companion diagnostics.
Through the continuous development of new technologies and products, ACROBiosystems Group creates value for the global pharmaceutical industry and actively empowers our partners. The company is dedicated to accelerating the drug development process, including targeted therapies, immunotherapeutic drugs, and its clinical applications, and contributes to global health.