ACROBiosystems

ACROBiosystems - Proteins and ELISA for target therapeutics

ACROBiosystems is an important manufacturer of reagents that are used in target therapeutic development. These include above all recombinant proteins. The products and services of our partner enable intuitive and optimized drug development processes.

Consistently high quality is particularly important to ACROBiosystems. This is reflected in a high consistency from batch to batch. Bioactivity is validated for most products. The validation is highly pure through HPLC/SDS-Page. The HEK293 expression system ensures natural conformation of the obtained proteins. A quality management certification according to ISO9001: 2015 and ISO13485:2016 not least reflects the focus on the high product quality of ACROBiosystems.

The core technologies of ACROBiosystems include the proprietary HEK293 expression platform with strict animal and xeno-free conditions, as well as the biotin labeling technology with optimized bioactivity (enzymatic and chemical). The own brand MABSol® proteins and assay kits is the result of years of experience and covers the step by step development of antibody drugs. In this portfolio you find biotin-labeled proteins for assays and quantitative analyzes, numerous antigens for injection and selection, Fc receptors for antibody optimization and so on.

ELISA kits are an accessible and flexible test format for biological tests. Enzyme-linked immunosorbent assays (ELISA) have been one of the most important methods for the detection of analytes for decades and are successfully developed and manufactured by ACROBiosystems. ELISA kits can be used for molecular screening or quantification, pharmacokinetic assays, and immunogenicity tests, among other things. The company offers a range of ready-to-use, universal ELISA kits. The dilution buffer included in the kit reduces backgrounds that can interfere with the result of your test. The indirect ELISA format is achieved by an antigen coating through the binding between biotin and streptavidin. The sensitivity can reach values of ng/ml. Our partner has a strict quality control program to ensure lot-to-lot consistency. ACROBiosystems ELISA kits save a lot of time and effort during your drug development process.

The ACROBiosystems catalog contains a comprehensive list of disease-associated biomarkers and drug targets from humans and other common species. All ACROBiosystems products are manufactured to a high quality and batch consistency to meet the strict standards of pharmaceutical research and development.

2020 ACROBiosystems has also specialised in COVID-19 relevant research reagents. These include proteins, antibodies, assay kits and various magnetic beads.

Ensuring Quality in Every Phase: ACROBiosystems' GMP Quality Management System

ACROBiosystems emphasizes the significance of safety and quality in raw and ancillary materials during pre-clinical and clinical phases. The company manufactures recombinant proteins adhering to USFDA GMP guidelines, ISO9001:2015, and ISO 13485:2016 quality management standards, utilizing animal-origin free materials. Stringent quality controls, including mycoplasma, viral, and in vivo toxicity tests, are implemented to ensure products do not impact the final product.

Material Selection Strategy: A Pivotal Element in Cell Therapy Development

The company, ACROBiosystems, recognizes the pivotal role of material selection in the successful translation of cell therapy products. They ensure adherence to regulatory criteria, following international standards such as ISO, US, and European Pharmacopeias. ACROBiosystems maintains a comprehensive quality management system, particularly focusing on cell therapy products' safety. The company invites industry partners for on-site audits, emphasizing confidentiality to foster collaborations.

Continuous Improvement: ACROBiosystems' Commitment to Quality Management

ACROBiosystems constantly enhances its Quality Management System (QMS) to support customers in cell therapy product development. The GMP quality management system surpasses regulatory requirements for raw and ancillary materials, and the company encourages on-site audits and ensures confidentiality to facilitate collaborations.

State-of-the-Art Facilities: Ensuring Clean and Sterile Production

The GMP facilities at ACROBiosystems include ISO Level 5 cleanrooms, ensuring automation and sterile conditions in the production process to minimize external contamination risks.

Pharmaceutical-Grade Material Procurement: Guaranteeing Quality and Safety

GMP products from ACROBiosystems utilize pharmaceutical-grade packaging materials, including glass vials and film-coated rubber stoppers, to guarantee seal quality, safety, and long-term stability, preventing moisture penetration.

Stringent Quality Control: Setting Industry Standards

ACROBiosystems maintains strict GMP quality control standards with extensive testing, including viral, TSE/BSE, mycoplasma, and acute/abnormal toxicity throughout the production process to prevent any adverse impact on the final product.

Transparency and Traceability: Regulatory Support Files for Confidence

For GMP-grade products, ACROBiosystems offers comprehensive documentation for transparency and traceability, including detailed quality inspection reports and analytical method verification reports.

Why Choose ACROBiosystems' GMP Products?

ACROBiosystems highlights the benefits of GMP products, emphasizing stringent quality management, comprehensive documentation, and commitment to GMP manufacturing guidelines. The company evaluates products for ex vivo manufacturing, conducts viral residue testing, and animal in vivo safety experiments to support customers' IND applications without disrupting the development process.

Navigating Material Choices: Are GMP Raw Materials Necessary?

ACROBiosystems addresses the necessity of GMP raw materials, emphasizing the critical material-selection strategy in developing cell therapy products. While GMP-grade materials simplify the transition to clinical stages, ACROBiosystems offers a diverse range of raw material products in various grades, supporting cell therapy manufacturers throughout the development process. Premium-grade products with similar bioactivity and performance at a lower cost are ideal for preclinical applications, allowing seamless transition to GMP-grade materials in the clinical phase.

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