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News, events, and resources

Feb 4, 2026

The 6 Most Common Analytical Gaps in Biosimilar Programs (and how to fix them) The 6 Most Common Analytical Gaps in Biosimilar Programs (and how to fix them) Learn the six most common analytical gaps in biosimilar development, why regulators flag them, and how to fix them early to reduce ...

Feb 3, 2026

WCBP 2026: Why Comparability is a Challenge for Late-Stage Biopharma WCBP 2026: Why Comparability is a Challenge for Late-Stage Biopharma WCBP 2026 highlights why comparability is now the key late-stage challenge, from analytical CQA assessment to regulatory expectations and ...

Jan 12, 2026

New Head of West Coast business development at CBS, Allan Cortes! New Head of West Coast business development at CBS, Allan Cortes! Allan Cortes joins CBS as Head of West Coast business development, bringing unparalleled experience in biotech and CRO business development.

Dec 22, 2025

Meet Us at WCBP 2026: All Symposium Details Included Meet Us at WCBP 2026: All Symposium Details Included Crystal Bio Solution is attending as exhibitor at WCBP 2026. What is WCBP, who should attend, and why it matters for CMC and biologics.

Dec 15, 2025

Sterility Assays in Drug and Device Manufacturing Sterility Assays in Drug and Device Manufacturing Sterility and endotoxin testing define release safety in biologics, ensuring microbial control, regulatory compliance, and patient ...

Dec 15, 2025

Critical Quality Attribute D0 Impact in ADC Modality Critical Quality Attribute D0 Impact in ADC Modality Overview of D0 species in ADCs, compete for target binding, reduce ADC potency, and how they are characterized analytically in development.

Dec 15, 2025

Critical Quality Attribute (CQA) in Antibody Drug Conjugate (ADC) Modality Critical Quality Attribute (CQA) in Antibody Drug Conjugate (ADC) Modality Overview of ADC components and related CQAs, highlighting how antibody, linker, and payload heterogeneity affect potency, stability and ...

Nov 21, 2025

Strategies for Antibody-Drug Conjugates Bioanalysis Strategies for Antibody-Drug Conjugates Bioanalysis Antibody-drug conjugates (ADCs) bioanalysis requires robust methods to track antibodies, payloads, and drug-to-antibody ratio changes in ...

Oct 9, 2025

Improving NAb Assay Sensitivity and Drug Tolerance by Optimizing MRD Improving NAb Assay Sensitivity and Drug Tolerance by Optimizing MRD Adjusting Minimal Required Dilution (MRD) from 1:4 to 1:2 in a competitive ligand binding assay improved NAb assay sensitivity 4-fold and ...

Sep 18, 2025

Representative Pooled Matrix Selection is Critical in ADA Assays Representative Pooled Matrix Selection is Critical in ADA Assays Our scientists developed a strategy to reduce false positives and improve the reliability of ADA assays
The 6 Most Common Analytical Gaps in Biosimilar Programs (and how to fix them) The 6 Most Common Analytical Gaps in Biosimilar Programs (and how to fix them) Learn the six most common analytical gaps in biosimilar development, why regulators flag them, and how to fix them early to reduce ...
Strategies for Antibody-Drug Conjugates Bioanalysis Strategies for Antibody-Drug Conjugates Bioanalysis Antibody-drug conjugates (ADCs) bioanalysis requires robust methods to track antibodies, payloads, and drug-to-antibody ratio changes in ...
WCBP 2026: Why Comparability is a Challenge for Late-Stage Biopharma WCBP 2026: Why Comparability is a Challenge for Late-Stage Biopharma WCBP 2026 highlights why comparability is now the key late-stage challenge, from analytical CQA assessment to regulatory expectations and ...
New Head of West Coast business development at CBS, Allan Cortes! New Head of West Coast business development at CBS, Allan Cortes! Allan Cortes joins CBS as Head of West Coast business development, bringing unparalleled experience in biotech and CRO business development.
Meet Us at WCBP 2026: All Symposium Details Included Meet Us at WCBP 2026: All Symposium Details Included Crystal Bio Solution is attending as exhibitor at WCBP 2026. What is WCBP, who should attend, and why it matters for CMC and biologics.
Sterility Assays in Drug and Device Manufacturing Sterility Assays in Drug and Device Manufacturing Sterility and endotoxin testing define release safety in biologics, ensuring microbial control, regulatory compliance, and patient ...
Critical Quality Attribute D0 Impact in ADC Modality Critical Quality Attribute D0 Impact in ADC Modality Overview of D0 species in ADCs, compete for target binding, reduce ADC potency, and how they are characterized analytically in development.
Critical Quality Attribute (CQA) in Antibody Drug Conjugate (ADC) Modality Critical Quality Attribute (CQA) in Antibody Drug Conjugate (ADC) Modality Overview of ADC components and related CQAs, highlighting how antibody, linker, and payload heterogeneity affect potency, stability and ...
Improving NAb Assay Sensitivity and Drug Tolerance by Optimizing MRD Improving NAb Assay Sensitivity and Drug Tolerance by Optimizing MRD Adjusting Minimal Required Dilution (MRD) from 1:4 to 1:2 in a competitive ligand binding assay improved NAb assay sensitivity 4-fold and ...
Representative Pooled Matrix Selection is Critical in ADA Assays Representative Pooled Matrix Selection is Critical in ADA Assays Our scientists developed a strategy to reduce false positives and improve the reliability of ADA assays

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