Antibody therapeutics, developed through advanced cell engineering and genetic engineering technologies, have become one of the fastest-growing segments in the pharmaceutical market. These biologics stand out for their high specificity, homogeneity, and ability to target disease pathways with precision. Today, antibody drugs are widely used in oncology and autoimmune disease treatment.
According to Frost & Sullivan, the global antibody therapeutics market is projected to reach USD 443.1 billion by 2030, reflecting a CAGR close to 20%. While monoclonal antibodies remain the largest class, future growth is expected to come from multispecific antibodies and antibody–drug conjugates (ADCs).
However, developing and commercializing antibody drugs is a complex, multi-stage process filled with uncertainty. At every step, rigorous quality control (QC) is essential to ensure product safety, efficacy, and regulatory compliance.
Figure 1. Antibody Drug R&D and Manufacturing Workflow
Below, we outline key QC checkpoints in antibody drug R&D and manufacturing, along with Yeasen’s product solutions designed to meet regulatory and industry standards.
Solution 1. Mycoplasma Detection
Cell-based therapies and biologics are highly susceptible to mycoplasma contamination, which can compromise safety and efficacy. Regulatory agencies require proof of mycoplasma-free production processes for cell banks, viral seed stocks, harvest fluids, and therapeutic cells.
Traditional methods include culture-based assays, indicator cell assays, and nucleic acid amplification techniques (NAT). Among these, qPCR-based NAT has become the gold standard for speed, sensitivity, and specificity.
Yeasen’s MycAway™ qPCR Mycoplasma Detection Kit (Probe, 2G) uses TaqMan probe–based qPCR to detect 183 species of mycoplasma DNA. Validated against EP 2.6.7 and JP G3 guidelines, it offers:
- High sensitivity and specificity
- Safety and reliability
- Compatibility with manual or automated nucleic acid extraction
This enables fast and accurate contamination monitoring during biomanufacturing.
Figure 2. Workflow of qPCR Mycoplasma Detection
Solution 2.Host Cell DNA (HCD) Detection
Residual host cell DNA is a critical quality attribute (CQA) due to potential immunogenicity, infectivity, or oncogenic risks. Regulatory limits include:
- China Pharmacopeia (2020): ≤100 pg/dose (mammalian systems); ≤10 ng/dose (bacterial/yeast)
- European Pharmacopeia: typically ≤10 ng/dose
- U.S. FDA: ≤100 pg/dose, relaxed up to 10 ng/dose for large-volume biologics
qPCR-based methods are the industry standard due to their superior sensitivity and specificity.
Yeasen’s CHO Residual DNA qPCR Kit delivers:
- Detection range: 3 fg/μL to 300 pg/μL
- Amplification efficiency: ~99%
- CV <15% across concentrations
This ensures reliable monitoring of residual DNA throughout development and production.
Figure 3. Standard curve for CHO DNA (3G) ranging from 3 fg/μL to 300 pg/μL, with an amplification efficiency of 99.29%. The coefficient of variation (CV) of detected values across concentrations is less than 15%.
Solution 3. Residual DNA Fragment Size Analysis
In addition to quantity, residual DNA fragment size is a regulatory concern. Fragments >200 bp may retain functionality and increase risk.
l U.S. FDA recommends keeping residual DNA ≤10 ng/dose and fragment size ≤200 bp.
l China CDE (2022) also highlights the need for both quantitative and fragment-size control.
Capillary gel electrophoresis with LIF is often used, but qPCR provides a faster, simpler alternative.
Yeasen’s Residual DNA Fragment Analysis Kit uses probe-based qPCR with four primer sets (94 bp, 115 bp, 252 bp, 505 bp) to quantify fragment size distribution, enabling manufacturers to control risk factors more effectively.
Solution 4. Host Cell Protein (HCP) Detection
Residual HCPs are another key CQA, as they can impact product safety and efficacy.
- China Pharmacopeia (2020): CHO HCP <0.05% (500 ppm); E. coli HCP <0.01%
- U.S. Pharmacopeia (USP <1132>): HCP below detection limit, typically <100 ppm
ELISA remains the method of choice, offering high sensitivity and broad coverage.
Yeasen’s HCP ELISA Kits feature:
- Double-antibody sandwich ELISA design
- Biotin–streptavidin amplification system for superior sensitivity
- Applicable across process development, impurity monitoring, and product release
Solution 5. Protein A Residual Detection
Protein A affinity chromatography is a standard step in antibody purification. However, trace amounts of Protein A leach into the product and must be removed to avoid immunogenicity or safety concerns.
- China Pharmacopeia (2020): Residual Protein A ≤0.001% of total protein
- USP <130>: Recommends monitoring and validating removal of Protein A during purification
Yeasen’s Protein A ELISA Kit quantifies residual Protein A with high sensitivity, supporting both process validation and final product release testing.
Figure 4. Experimental workflow of Protein A residue detection using Yeasen’s ELISA method
Related Product
|
Category |
Name |
Cat.No. |
Size |
|
|
Host Cell Residual DNA Detection |
Sample Preparation Kits |
18461ES |
25T/100T |
|
|
18469ES |
3×16T/ 6×16T |
|||
|
Automated nucleic acid extraction system |
80511ES |
48 channels |
||
|
Residual DNA Detection Kits |
41332ES |
50 T/100 T |
||
|
DNA Fragment Analysis Kits |
CHO Host Cell Residue DNA Size Analysis Kit |
41334ES |
4×50 T/ 4×100 T |
|
|
Host Cell Residual Protein (HCP) Detection |
HCP ELISA Kits |
CHO HCP ELISA kit (CHO-K1) |
36714ES |
48 T/96 T |
|
Protein A Residual Detection |
Protein A ELISA Kit |
36716ES |
48 T/96 T |
|
|
Mycoplasma Detection |
qPCR Detection Kits |
40619ES |
25 T/100 T |
|