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Cancer Vaccine Formulation Development

Cancer-Vaccine-Formulation-DevelopmentCancer vaccines are complex and costly products, with a high risk in long-term research, development, and manufacture. Thus, it is necessary to maximize the potential of rapid formulation development. To achieve this goal, the historical methods for formulation development needs to be updated in a rational and systematic way allowing for better cancer vaccine formulations.

In Creative Biolabs, we offer a diversity of approaches involving biophysical characterization of antigens, evaluation of stabilizers, investigation of interactions between antigen and adjuvants, assessment of product contact materials, and stability monitoring both in real-time and accelerated conditions. With the information gained from these studies, there is a great increase in the probability of rapidly developing a safe, effective, and stable cancer vaccine formulation.

Cancer Vaccine Formulation Services at Creative Biolabs

There are two main goals of formulation development. One is to improve the immunogenicity of the vaccine and the other is to improve the stability of vaccine components. At Creative Biolabs, we have designed comprehensive services for cancer vaccine formulation optimization, and each of which takes place in multiple phases of development and is complementary to each other. Besides, our teams have rich experience and dedicated equipment to predict and address potential issues in formulation development processes for the supply of high-quality cancer vaccines.

  • Key Strategies
    1. Formulation studies, such as optimizing adjuvanted cancer vaccine candidates, operating stability studies, developing analytical methods to characterize antigen-adjuvant combinations;
    2. Pre-clinical evaluation of adjuvanted cancer vaccines, including immunogenicity studies in diverse animal models;
    3. Protocols on the manufacture and quality control (QC) of modern adjuvants;
    4. Validating cancer vaccine-adjuvant formulation and characterization, both in theory and practice.
  • Featured Formulation Development Services
  • Components of a rational and systematic approach to the development of vaccine formulations.

    Fig.2 Components of a rational and systematic approach to the development of vaccine formulations. (Morefield, 2011)

    1. Biophysical Characterization: Optimized formulation parameters of pH, ionic strength, dose suitability, and buffer species.
    2. Stabilizer Screening: Investigation of generally regarded as safe (GRAS) excipients, such as amino acids, antioxidants, cyclodextrins, proteins, sugars/sugar alcohols, surfactants, etc.
    3. Adjuvant Interactions: To maintain antigenic immunogenicity with highly purified antigens, including aluminum adjuvants, mineral salt adjuvants, oil adjuvants, liposomes, etc.
    4. Sterile Filtration: Typical filter membranes used, including polyethersulfone (PES), cellulose acetate (CA), and polyvinylidene fluoride (PVDF).
    5. Bioavailability Enhancement: To increase the bioavailability of ingredients.
    6. Stability Studies: The compatibility assessment of complex vaccine formulations.
    7. Container Interactions: Improved process and coordination for more effective production.
    8. Delivery Systems: To assure safety, efficacy for vaccine components stable during manufacturing and storage, including emulsion, microspheres, nanoparticle, immune stimulating complexes (ISCOMs), etc.
  • Analytical Chemistry Toolkits
    • High performance liquid chromatography (HPLC)
    • Gas chromatography (GC)
    • Mass spectrometry (MS)
    • Liquid chromatography-mass spectrometry (LC-MS)

Highlights from Creative Biolabs

  1. Wide Range of Applications: formulation considerations for various cancer vaccine types
  2. Full-scale Strategies: Multiple services for cancer vaccine formulation development
  3. Rational Processes: process development for solution, suspension, and lyophilized product
  4. Advanced schemes: multi-component cancer vaccines and novel delivery mechanisms

As an expert in the vaccine industry, Creative Biolabs can provide access to adjuvants, bespoke adjuvant R&D activities, adjuvant quality control technology, as well as formulation expertise, training, access to GMP adjuvants, so that customers gain optimal benefit from the use of cancer vaccine formulation technology.

For more details regarding the formulation development of cancer vaccines, please don’t hesitate to contact us.

Reference

  1. Morefield, G.L. A rational, systematic approach for the development of vaccine formulations. AAPS J. 2011,13(2): 191-200.

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