Immune Response Manufacturing Trials 
XTalks
JANUARY 22, 2025
The VLA1553-321 trial, conducted in Brazil, was the first to assess the vaccine in an endemic region. The study included 754 adolescents, comparing immune responses and safety profiles between vaccine and placebo groups. These sustained responses build on earlier data showing 99.1% efficacy at six months and 98.8%
Bio Pharma Dive
OCTOBER 1, 2020
Worrisome immune responses had led the FDA to halt Solid's study. Now, the agency will permit Solid to continue after the biotech made adjustments to its manufacturing and patient enrollment procedures.
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Drug Patent Watch
DECEMBER 9, 2024
These large, complex molecules are made inside living cells, which can lead to small variations in the manufacturing methods that can have a significant impact on the final product. Robust Clinical Trial Design : Clinical trials for biosimilars should be designed to demonstrate equivalence or non-inferiority to the reference product.
World of DTC Marketing
DECEMBER 29, 2020
Both the Pfizer and Moderna vaccines copied RNA sequence from the virus genome and found a way to manufacture it at scale with high-level processes and quality control. Another consideration is that while in traditional vaccine development, clinical trials are carried out in sequence. 1455NO-HEALTH-CORONAVIRUS_VACCINES_PFIZER_O_.
Pharmaceutical Technology
NOVEMBER 22, 2022
When an mRNA vaccine is administered, a patient’s body produces that protein to prompt a desired immune response. This approach to vaccination offers many advantages to developers, including quick development, high potency, a favorable safety profile, and the potential for cost-effective manufacturing.
Pharmaceutical Technology
SEPTEMBER 14, 2022
As an autologous cell therapy, manufacturing the infusion product is a highly specialised process involving tumour harvest and the extraction and large-scale ex vivo expansion of TILs. The use of engineered immune cytokines that selectively induce the expansion of TILs is being investigated as an alternative to IL-2 stimulation.
Pharmaceutical Technology
AUGUST 15, 2022
The latest MHRA decision is based on findings from the Phase II/III clinical trial, where the mRNA-1273.214 vaccine met all primary endpoints. In baseline seronegative subjects, the updated vaccine offered a superior neutralising antibody response against Omicron (BA.1) 1) versus the 50µg mRNA-1273 booster dose.
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