A Regulatory Perspective on Testing of Biological Activity of Complex Biologics

Trends in Biotechnology

Volumn 36, Issue 3, 2018, Pages 231-234

  Saldanha, Marianne ^a   Dandekar, Prajakta ^a   Jain, Ratnesh ^a  

^a INSTITUTE OF CHEMICAL TECHNOLOGY   (India)

Author keywords

antibody drug conjugates; binding activity; bispecific antibodies; potency; regulatory guidelines

Indexed keywords

BIOACTIVITY;

ANTIBODY-DRUG CONJUGATES; BINDING ACTIVITIES; COMPLEX BIOLOGICS; COMPLEX STRUCTURE; POTENCY; REGULATORY GUIDELINES;

ANTIBODIES;

ANTIBODY DRUG CONJUGATE; BLINATUMOMAB; BRENTUXIMAB VEDOTIN; CATUMAXOMAB; RECOMBINANT DNA; TRASTUZUMAB EMTANSINE; ANTINEOPLASTIC AGENT; BIOLOGICAL PRODUCT; BISPECIFIC ANTIBODY; CYTOTOXIN; IMMUNOTOXIN; MONOCLONAL ANTIBODY;

BIOASSAY; BIOLOGICAL ACTIVITY; COMPLEX FORMATION; DRUG APPROVAL; DRUG CONTROL; DRUG EFFICACY; DRUG MONITORING; DRUG POTENCY; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; IMMUNOGENICITY; PRACTICE GUIDELINE; PRIORITY JOURNAL; SHORT SURVEY; STRUCTURE ACTIVITY RELATION; SURFACE PLASMON RESONANCE; HUMAN; STANDARDS; UNITED STATES;

ANTIBODIES, BISPECIFIC; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC AGENTS; BIOLOGICAL PRODUCTS; CYTOTOXINS; DRUG APPROVAL; GUIDELINES AS TOPIC; HUMANS; IMMUNOTOXINS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 85039943711     PISSN: 01677799     EISSN: 18793096     Source Type: Journal    
DOI: 10.1016/j.tibtech.2017.12.004     Document Type: Short Survey

References (15)

1. Carter, P.J., Introduction to current and future protein therapeutics: a protein engineering perspective. Exp. Cell Res. 317 (2011), 1261–1269.
2. Junutula, J.R., Gerber, H.-P., Next-generation antibody–drug conjugates (ADCs) for cancer therapy. ACS Med. Chem. Lett. 7 (2016), 972–973.
3. FDA, Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products. 2011, FDA.
4. Lee, H.Y., et al. “Two-in-one” approach for bioassay selection for dual specificity antibodies. J. Immunol. Methods 448 (2017), 74–79.
5. Gassner, C., et al. Development and validation of a novel SPR-based assay principle for bispecific molecules. J. Pharm. Biomed. Anal. 102 (2015), 144–149.
6. Wakankar, A., et al. Analytical methods for physicochemical characterization of antibody drug conjugates. MAbs 3 (2011), 161–172.
7. FDA, Guidance for Industry: Immunogenicity Assessment for Protein Therapeutic Products. 2014, FDA.
8. Del Bano, J., et al. Taking up cancer immunotherapy challenges: bispecific antibodies, the path forward?. Antibodies, 5, 2015, 1.
9. EMA, Guideline on Potency Testing of Cell Based Immunotherapy Medicinal Products for the Treatment of Cancer. 2016, EMA.
10. USP, US Pharmacopeia and National Formulary (USP 35). 2012, US Pharmacopeial Convention, 106–117.
11. USP, United States Pharmacopeia and National Formulary (USP 35–NF 30). 2012, US Pharmacopeial Convention, 5162–5174.
12. EMA, Guideline on Production and Quality Control of Monoclonal Antibodies and Related Substances. 2007, EMA.
13. ICH, S9 Guideline: Non-clinical Evaluation for Anticancer Pharmaceuticals. 2009, ICH.
14. ICH, S9 Guideline: Nonclinical Evaluation for Anticancer Pharmaceuticals – Questions and Answers. 2016, ICH.
15. Barok, M., et al. Trastuzumab emtansine: mechanisms of action and drug resistance. Breast Cancer Res., 16, 2014, 209.