Search Results - "vaccination"

Vaccine manufacturing part 1 of 2 /

Table of Contents: “…Contents: The vaccine ecosystem -- How to make a vaccine (brief outline) -- Vaccine antigens -- Assessing vaccine quantities -- Technology & knowledge transfer -- Process development and scaling-up.…”
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Cancer vaccines part 1 of 2 /

Table of Contents: “…Contents: The hallmarks of cancer -- Categories of cancer-associated antigens -- Viral & non-viral cancers: vaccine targets -- Immunotherapeutics -- Immunologic reagents approved for cancer therapy -- Clinical outcome based on immune response -- CTL-based therapy -- Virus-specific CTL adoptive transfer therapy -- Immunotherapy for Melanoma.…”
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Vaccine adjuvants part 1 of 2 /

Table of Contents: “…Contents: Overview of vaccine adjuvants -- First generation particles -- Alum adjuvants -- MF59 adjuvant -- Polylactide co-glycolide particles.…”
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Vaccine manufacturing part 2 of 2 /

Table of Contents: “…Contents: New vaccines & the need for up-to-date technology -- Considerations for manufacturing facilities -- Quality systems (The mechanism for regulatory compliance) -- Large scale, routine manufacturing -- Warehousing and distribution of vaccine product.…”
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Vaccine adjuvants part 2 of 2 /

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Vaccine delivery

Table of Contents: “…Contents: Introduction to immunization (prophylactic vaccines) -- Vaccine formulation -- Types of antigens -- Vaccine delivery routes (parenteral, mucosal, cutaneous) -- Vaccine delivery systems (needle and syringe, needle-free systems) -- Vaccine adjuvants (history, classification, mechanism of action) -- Adjuvants approved with the product -- Edible plant-based vaccines and therapeutic vaccines.…”
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Vaccine preclinical studies part 1 of 2 /

Table of Contents: “…Contents: Introduction to vaccine research -- Goals of preclinical studies -- Preclinical safety for vaccines -- Drug vs. vaccine toxicology -- Basic vaccine toxicology -- Specialized toxicology studies.…”
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HIV vaccine development

Table of Contents: “…Contents: HIV virus biology and immune mechanisms -- Development of an HIV vaccine & accompanying difficulties -- New methods of vaccine development -- The ideal HIV vaccine -- HIV vaccine efficacy trials.…”
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Developing tuberculosis vaccines challenges and strategies, part 1 of 2 /

Table of Contents: “…Contents: M. tuberculosis exposure and infection -- Tuberculosis (TB) disease -- Antimicrobial Mtb resistance -- The BCG vaccine -- Challenges of the TB vaccine field -- Potential new & better vaccines -- The variety of Mtb antigens.…”
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Bacterial vaccines in development part 1 of 2 /

Table of Contents: “…Contents: New bacterial vaccines in clinical development -- Phases of vaccine development -- Principles of vaccine antigen discovery & validation -- Novel vaccines in development for Gram+ pathogens: C. difficile.…”
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Bacterial vaccines in development part 2 of 2 /

Table of Contents: “…Contents: Novel vaccines for Gram+ pathogens: S. aureus -- Novel vaccines for Gram- pathogens N. meningitides serogroup B.…”
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Vaccine preclinical studies part 2 of 2 /

Table of Contents: “…Contents: Vaccine pharmacology -- Vaccine immunogenicity -- Vaccine challenge-protection studies.…”
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Future directions for vaccine discovery part 1 of 2 /

Table of Contents: “…Contents: Vaccine R&D: too slow, high failure rate -- HIV vaccine goal: induce broadly neutralizing antibodies (bNAb) -- Mimicking nature to create bNAb -- Rules for inducing primary response with memory B cell breadth.…”
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Approaches to nonclinical vaccine development

Table of Contents: “…Contents: Brief history of vaccination -- How vaccines work -- The importance of vaccination -- Current regulatory guidelines for vaccines -- Considerations in the design of toxicity studies -- Routine toxicity studies for vaccines -- Nonclinical toxicity testing strategies.…”
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Biodefense and special pathogen vaccines in development part 1 of 2 /

Table of Contents: “…Contents: Brief history of bioterrorism -- Bioterrorism agents -- Types of vaccines -- Vaccine development: special requirements -- Unique aspects of biodefense vaccines.…”
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SARS-COV-2 vaccine development where are we now? /

Table of Contents: “…Contents: Vaccine development for SARS-COV-2: Current position -- Different types of potential vaccines against COVID-19 -- New technologies and their implications -- How past experience can support current research.…”
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Regulatory considerations for vaccine development, talk 2 clinical regulatory considerations (part 1 of 2) /

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Regulatory considerations for vaccine development, talk 1 chemistry, manufacturing and control /

Table of Contents: “…Contents: Functions of the FDA/CBER/OVRR -- Definition and types of vaccines -- Evolution & legal framework for vaccine regulations -- Drug substance and product -- CMC development -- Vaccine manufacturing -- Preclinical evaluation -- Process validation -- Novel technologies.…”
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Regulatory considerations for vaccine development, talk 2 clinical regulatory considerations (part 2 of 2) /

Table of Contents: “…Contents: Biological License Application (BLA) pathways -- Traditional, accelerated approval, "Animal Rule" -- Programs that accelerate the clinical testing (IND) and review (BLA) processes -- Fast track designation -- Breakthrough designation -- Priority review -- The package insert -- Pediatric study requirements -- Adjuvants -- Adaptive trial design from a regulatory perspective -- Developing vaccines for global infectious diseases.…”
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The development of SARS-CoV-2 vaccines

Table of Contents: “…Contents: Overview of three SARS-CoV-2 vaccines being developed -- Technologies being used -- Manufacturability -- Current stage of testing -- Next steps.…”
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