DAIDS Translational Research Program for HIV-Targeted Product Development & Manufacturing

The Division of AIDS (DAIDS) offers a unique venture to enable, facilitate, operationalize and translate vaccine developers’ concepts into current good manufacturing practice (cGMP)-manufactured, vialed products for clinical trials. The program manages and supports a broad portfolio of HIV vaccine assets by providing translational expertise, services, and resources in advancing HIV-vaccine development. DAIDS works closely with academic innovators, biotech, pharmaceutical companies, non-profits, vaccine trial networks, and contract manufacturing and contract research organizations (CMOs, CROs) to advance clinical HIV vaccine development. In addition, the program provides integrated quality assurance and regulatory guidance/expertise in compliance with FDA regulations by preparing and supporting regulatory filings.

Contact Information

Main Areas of Focus

  • HIV vaccine product development and phase-appropriate cGMP manufacturing 
  • Broad product portfolio of HIV vaccine assets 
    • Complex recombinant envelope HIV protein immunogens (gp120s, gp140 trimers)
    • Adenoviral vectors (CMV, Chimp-Ad)
    • Modified vaccinia ankara virus (MVAs)
    • Virosomes
    • DNA vaccines 
    • Messenger RNA (mRNA)-LNP vaccines 
    • Self-assembling HIV nanoparticle vaccines
    • Synthetic nanoparticle HIV vaccines
  • Vaccine product lifecycle management
    • Scientific, operational, and project management
    • Subject matter experts/technical expertise
    • Transitioning innovations from the laboratory
    • Product, process development, GMP manufacturing, fill-finish activities
    • Product development technology transfer
    • Feasibility and screening evaluations 
    • Analytical development
    • Formulation development
    • Quality assurance and quality management systems compliance with FDA regulations
    • Audits, quality agreements
    • Record review (master batch records, certificates of analysis and conformance , validation methods)
    • Short- and long-term stability testing
    • Regulatory writings, support, and FDA submissions (pre/post-investigational new drug [IND])
    • Product release to support clinical trials
    • Contracts and budget management
    • Material transfer agreements, confidence disclosure agreements (CDAs)
  • Capacity-building initiatives for translational product development and vaccine manufacturing
  • Enabling technologies, platforms, and innovations to accelerate HIV vaccine manufacturing
    • Cell-line development processes and platforms 
    • Upstream process development and downstream purification approaches 
  • Nanoparticle-based immunogen and adjuvant co-delivery systems
  • Procuring GMP-quality new/biosimilar adjuvants for clinical trials
  • Antigen-adjuvant formulation compatibility studies
  • Gene delivery, neutralizing monoclonal antibodies (mAbs), and HIV entry inhibitors

Funding

DAIDS offers a number of funding opportunities, including grants and contracts, to conduct translational research and development for clinical evaluation. NIAID works with funded contractors to offer services to investigator’s to manage and accelerate the product development, process development and cGMP manufacturing, and product lifecycle management to advance it into clinical trials.

Current funding opportunities include


Read more about funding opportunities from our program

Cost

These services are provided at no cost to investigators.

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