At CD Bioparticles, we understand that GMP compliance is not just a regulatory checkbox—it is a promise of consistency, safety, and reliability. Our magnetic bead GMP production service is built on three core pillars: technical excellence, regulatory alignment, and customer-centric flexibility. With over a decade of experience in bioparticle manufacturing, our team of scientists, engineers, and quality assurance (QA) specialists works closely with clients to translate their unique requirements into scalable, GMP-compliant products. Whether you need small-batch prototypes for preclinical testing or large-scale production for commercial launch, we have the infrastructure, expertise, and agility to support your project at every stage.
Overview
CD Bioparticles offers a full‑cycle, cGMP‑compliant manufacturing platform for custom magnetic beads used in diagnostics, therapeutics, and cell‑based research. From early‑stage design through large‑scale production and final release testing, we deliver sterile, endotoxin‑controlled bead batches that meet GMP requirements. Our service is built on a closed, modular production line, validated analytical methods, and a dedicated project‑management team that ensures on‑time delivery and strict confidentiality.
Our Services
Customizable Surface Functionalization
We offer a wide range of GMP-compliant surface modifications to enable specific target binding, including:
- Covalent Functional Groups: Amines (-NH₂), carboxyls (-COOH), hydroxyls (-OH), or thiols (-SH) for conjugation to antibodies, proteins, or nucleic acids.
- Affinity Ligands: Streptavidin, Protein A/G, or oligonucleotides (e.g., oligo(dT) for mRNA extraction) for direct use in capture assays.
- Passivation Coatings: PEG (polyethylene glycol) or BSA (bovine serum albumin) to reduce non-specific binding and improve biocompatibility—critical for cell therapy or in vivo applications.
Scalability and Flexibility
Our production lines are designed for seamless scaling:
- Lab to Commercial Scale: We start with milligram-scale prototypes for feasibility testing, then scale to gram, kilogram, or even multi-kilogram batches for commercial supply.
- Rapid Turnaround: For time-sensitive projects (e.g., emergency diagnostic development), we offer expedited production schedules without compromising GMP compliance.
GMP Production and In-Process Control
CD Bioparticles follows a standardized, document-controlled workflow to ensure transparency and quality at every step.
- Magnetic Core Synthesis: GMP-grade iron oxide nanoparticles are synthesized via co-precipitation or thermal decomposition, with IPC testing for particle size and purity.
- Polymer Coating: The magnetic core is encapsulated in a biocompatible polymer (e.g., polystyrene, polyacrylic acid) to form stable beads, with IPC for coating thickness and uniformity.
- Surface Functionalization: The beads are modified with the desired functional groups or ligands, with IPC for conjugation efficiency and ligand density.
- Purification and Sterilization: Beads are purified via centrifugation or chromatography to remove impurities, then sterilized using GMP-validated methods (e.g., autoclaving, gamma irradiation, or ethylene oxide (EtO) sterilization).
Quality Control & Release Testing
Every batch undergoes a comprehensive QC panel:
- Particle size analysis – Dynamic light scattering (DLS) and microscopy to confirm size distribution.
- Magnetization measurement – Vibrating sample magnetometer (VSM) to verify magnetic strength.
- Ligand density – UV‑Vis or ELISA‑based quantification of bound protein/antibody.
- Sterility & Endotoxin – USP <71> sterility test and LAL assay (< 0.05 EU/mL).
- Functional assay – Target capture efficiency in a representative matrix (e.g., plasma, cell culture).
Our Process
Our approach is highly collaborative, ensuring the final product meets your exact specifications:
Synthesis and
functionalization
Characterization and
validation
Quality assurance and
delivery
Our Advantages
High Purity and Yield
Our optimized protocols and high-quality reagents ensure that you get a highly pure and concentrated exosome sample. This is critical for downstream analysis, as it minimizes background noise and allows for more accurate and sensitive results.
Speed and Efficiency
Magnetic bead-based isolation is significantly faster than ultracentrifugation. This efficiency allows for a higher sample throughput, making it ideal for large-scale studies and clinical applications.
Preserved Integrity
The gentle nature of our method ensures that the exosomes remain intact and their biological activity is preserved. This is vital for applications where the function of the exosome or its cargo needs to be studied.
Ready to discuss your GMP magnetic bead requirements? Our technical sales team is available to review your specifications and develop a customized manufacturing strategy. Contact us today to request a quote or schedule a technical consultation.
