Asian Journal of Pharmaceutical Research

Open Access Open Access  Restricted Access Subscription Access
Open Access Open Access Open Access  Restricted Access Restricted Access Subscription Access

Stability testing: An Essential study for Vaccine Formulation Development


Affiliations
1 B. K. Mody Government Pharmacy College, Rajkot-360003, Gujarat, India
     

   Subscribe/Renew Journal


Forced degradation studies are carried out at a more severe condition than accelerated conditions. Stress studies for vaccines are carried out in the early stage of development. By conducting stress studies, we can know the chemical behavior of our molecule which is important while developing formulation, packaging, transportation, storage, etc. there are general regulatory guidelines are available for conducting forced degradation studies but there is no sufficient information provided about how to perform forced degradation studies. Thus, this review discussed stress testing studies of vaccines, mechanisms of vaccine degradation, also analytical methods which are helpful to develop a method for forced degradation.


Keywords

Vaccine, Stability testing of the vaccine, Forced degradation, Analytical Methods, Degradation Mechanism
Subscription Login to verify subscription
User
Notifications
Font Size


  • Rashmimala Pradhan. Effectiveness of Information Booklet on Immunization among GNM 1st Year Students in a Selected Nursing School at Bhubaneswar, Odisha. Asian J. Nur. Edu. and Research. 2015; 5(1): 64-66.

  • Saraswathi. K.N, Lissa J. A study to assess the knowledge on selected optional vaccines among mothers of under-five children in selected immunization centers at Mysore with the view to developing an information booklet. Asian J. Nur. Edu. and Research. 2014; 4(4): 513-515

  • Blessy M, Patel R, Prajapati P, Agrawal Y. Development of forced degradation and stability indicating studies of drugs—A review. Asain Journal of Pharmaceutical Analysis. 2013; 4(3): 159-165.

  • Patel P . U., Prajapati A.M., Patel M.M. Development and validation of analytical methods for estimation of Levosimendan in the injectable dosage form. Research J. Pharm. and Tech. 2012;5(12): 1543-1548.

  • Vysakh Visweswaran, Ameya Binoy, Anjana Sreenivas, B Abhinand, Meenu Vijayan. Vaccines-Pillars of Preventive Health. Research J. Pharm. and Tech. 2017; 10(9): 3205-3210.

  • Ananya K V, Amit B Patil, D V Gowda, Preethi S. Adjuvants employed in the Fabrication of sublingual vaccines. Research J. Pharm. and Tech. 2020; 13(8): 3957-3962.

  • Hasija M, Lillian L. Forced degradation studies: an essential tool for the formulation development of vaccines. J. Vaccine: Development and Therapy. 2013; 3: 11-33.

  • Shubhangi V. Sutar, Veerendra. C. Yeligar, Shitalkumar S. Patil. Stability Indicating Forced Degradation Studies. Research J. Pharm. and Tech. 2019; 12(1): 429-433.

  • Md. Jakaria, Md. Hazrat Ali, Md. Areeful Haque, Mohammed Abu Sayeed, Shoayeb Ahmed. In-vitro Comparative Forced Degradation Study of Different Brands and Active form of Montelukast sodium using UV Spectrophotometer. Asian J. Pharm. Ana. 2015; 5(1): 26-30.

  • Parag A. Pathade, Vinod A. Bairagi, Yogesh S. Ahire, Bhaskar O. Aher. Development and Validation of Stability Indicating UV Spectrophotometric Method for Estimation of Teneligliptine in Bulk and Tablet Dosage Form. Asian J. Pharm. Ana. 2019; 9(3):128-132.

  • Hawe A, Wiggenhorn M. Forced Degradation of Therapeutic Proteins” J. Journal of Pharmaceutical Sciences. 2012; 101(3): 895-913.

  • Iram F, Iram H, Iqbal A, Husain A. Forced Degradation Studies. J. Journal of Analytical & Pharmaceutical Research. 2016; 3(6): 1-5.

  • ICH – Harmonized Tripartite Guideline. Photostability Testing of New Drug Substances and Products Q1B. International Conference on Harmonization, IFPMA, Geneva, Switzerland, 2005.

  • ICH – Harmonized Tripartite Guideline.Validation of Analytical Procedures: Text and Methodology. Q2(R1). International Conference on Harmonization IFPMA, Geneva, Switzerland, 2005.

  • ICH – Harmonized Tripartite Guideline. Impurities in New Drug Substances. Q3A(R2). International Conference on Harmonization, IFPMA, Geneva, Switzerland, 2005.

  • ICH – Harmonized Tripartite Guideline. Impurities in New Drug Products. Q3B(R2). International Conference on Harmonization, IFPMA, Geneva, Switzerland, 2005.

  • ICH – Harmonized Tripartite Guideline. Stability Testing of Biotechnological/ Biological Products. Q5C. International Conference on Harmonization, IFPMA, Geneva, Switzerland, 2005.

  • ICH – Harmonized Tripartite Guideline. Test Procedures and Acceptance Criteria for Biotechnological/ Biological Products. Q6B. International Conference on Harmonization, IFPMA, Geneva, Switzerland, 2005.

  • ICH – Harmonized Tripartite Guideline. Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. Q8(R2). International Conference on Harmonization, IFPMA, Geneva, Switzerland, 2005.

  • ICH – Harmonized Tripartite Guideline. Development and Manufacture of Drug Substances Q11. International Conference on Harmonization, IFPMA, Geneva, Switzerland, 2005.

  • WHO/KFDA Workshop on Stability Evaluation of Vaccines, Seoul, Republic of Korea 30 March 2009.

  • Chan C. Forced degradation studies: current trends and future perspectives for protein-based therapeutics. J. Expert Review of Proteomics. 2016; 1744.

  • Clapp T, Siebert P, Chen D, Jones Braun L. Vaccines with aluminum-containing adjuvants: optimizing vaccine efficacy and thermal stability. Journal of Pharmaceutical Science. 2010; 100: 388-401.

  • Patel K, Borchardt R. Chemical Pathways of Peptide Degradation. III. Effect of Primary Sequence on the Pathways of Deamidation of Asparaginyl Residues in Hexapeptides. J. Pharmaceutical Research. 1990; 7(7): 787–793.

  • Chi E, Krishnan S, et al. Physical Stability of Proteins in Aqueous Solution: Mechanism and Driving Forces in Nonnative Protein Aggregation. J. Pharmaceutical Research. 2003; 20(9):1325–1336.

  • Bolgiano B, Mawas F, Yost SE, Crane DT, Lemercinier X, Corbel MJ. Effect of Physico-chemical modification on the immunogenicity of Haemophilus influenzae type b oligosaccharide -CRM (197) conjugate vaccines. J. Vaccine. 2000. D`1Qaq11`ZWS4

  • Estey T, Vesely C, Randolph W, et al. Evaluation of chemical deg- radation of a trivalent recombinant protein vaccine against botulinum neurotoxin by LysC peptide mapping and MALDI-TOF mass spectrometry. Journal of Pharmaceutical Science. 2019; 98: 2994-3012.

  • Singh S, Junwal M, Modhe G, Tiwari H, Kurmi M, Parashar N, Sidduri P. Forced degradation studies to assess the stability of drugs and products. J. Trends in Analytical Chemistry. 2013.

  • Goldberg A. Protein degradation and protection against misfolded or damaged proteins. J. Nature. 2003; 426: 895–899.

  • Majumdar S, Ford BM, Mar KD, et al. Evaluation of the effect of syringe surfaces on protein formulations. Journal of Pharmaceutical Sciences. 2011; 100: 2563–2573.

  • kissmann J, Ausar SF, Rudolph A, et al. Stabilization of measles virus for vaccine formulation. J. Human Vaccine. 2008; 4(5): 50-359.

  • Habig WH. Potency testing of bacterial vaccines for human use. J. Veterinary Microbiology. 1993; 37: 343-351.

  • Poland GA, OvsyannikovaIG, Johnson KL, Naylor S. The role of mass spectrometry in vaccine development. J. Vaccine. 2001; 2692–2700.

  • Ratliff T, Ritchey J, Brandhorst J, et al. Time-dependent aggregation of reconstituted BCG vaccine. The Journal of Urology. 1994; 152: 2147-2149.

  • Krell T, Manin C, et al. Characterization of different strains of poliovirus and influenza virus by differential scanning calorimetry. Biotechnol Appl Biochem. 2005; 241–246.

  • Ausar F, Chan J, Hoque W, James O, Jayasundara K, Harper K. Application of extrinsic fluorescence spectroscopy for the high throughput formulation screening of aluminum-adjuvanted vaccines. Journal of Pharmaceutical Science. 2011; 100: 431-440.

  • Maddux NR, Joshi SB, Volkin DB, Ralston JP, Middaugh CR. Multidimensional methods for the formulation of biopharmaceuticals and vaccines. J. Pharm Sci. Epub. 2011.

  • Chang S, Kendrick S, Carpenter F. Surface-induced denaturation of proteins during freezing and its inhibition by surfactants. Journal Pharmaceutical Science. 1996; 85(12): 1325–1330.

  • Kolhe P, Badkar A. Protein and solute distribution in drug substance containers during frozen storage and post-thawing: a tool to understand and define freezing-thawing parameters in biotechnology process development. Biotechnol Prog. 2011; 27(2): 494–504.


Abstract Views: 65

PDF Views: 0




  • Stability testing: An Essential study for Vaccine Formulation Development

Abstract Views: 65  |  PDF Views: 0

Authors

Amitkumar J. Vyas
B. K. Mody Government Pharmacy College, Rajkot-360003, Gujarat, India
Sinchan M. Patel
B. K. Mody Government Pharmacy College, Rajkot-360003, Gujarat, India
Ashok B. Patel
B. K. Mody Government Pharmacy College, Rajkot-360003, Gujarat, India
Ajay I. Patel
B. K. Mody Government Pharmacy College, Rajkot-360003, Gujarat, India
Nilesh K. Patel
B. K. Mody Government Pharmacy College, Rajkot-360003, Gujarat, India
Suuny Shah
B. K. Mody Government Pharmacy College, Rajkot-360003, Gujarat, India
Devang Sheth
B. K. Mody Government Pharmacy College, Rajkot-360003, Gujarat, India

Abstract


Forced degradation studies are carried out at a more severe condition than accelerated conditions. Stress studies for vaccines are carried out in the early stage of development. By conducting stress studies, we can know the chemical behavior of our molecule which is important while developing formulation, packaging, transportation, storage, etc. there are general regulatory guidelines are available for conducting forced degradation studies but there is no sufficient information provided about how to perform forced degradation studies. Thus, this review discussed stress testing studies of vaccines, mechanisms of vaccine degradation, also analytical methods which are helpful to develop a method for forced degradation.


Keywords


Vaccine, Stability testing of the vaccine, Forced degradation, Analytical Methods, Degradation Mechanism

References