Preliminary studies with a variety of cell-based vaccines suggest target accessibility (potential immunogenicity) to immune-directed approaches in a variety of solid tumors. However, four primary factors limit the generation of effective immune-mediated anticancer activity in therapeutic applications: 1) identifying and/or targeting cancer-associated immunogen(s) (target) in an individual patient; 2) insufficient or inhibited level of antigen-presenting cell (dendritic cell, macrophage) priming and/or presentation; 3) suboptimal T cell activation (potency) and proliferation; and 4) cancer-induced inhibition of the anticancer immune response in both afferent and efferent limbs…
Tag: <span>vaccines</span>
We have designed a novel autologous vaccine by combining two vaccine strategies that have each been previously tested in separate non-small cell lung cancer (NSCLC) clinical trials: 1) a GM-CSF gene transduced tumor cell vaccine; and 2) a TGFβ2 antisense gene transduced cell vaccine. Each has demonstrated similar beneficial effects without any evidence of significant toxicity in advanced cancer patients…
In order to move product development forward, the majority of biotech companies and academic institutions involved in cell-based therapies need new facilities in order to scale up production capabilities and comply with evolving regulatory requirements. Some institutions choose to use a contract manufacturing organization (CMO) to benefit from established expertise while others support their clinical development programs with their own dedicated production facility. The main challenges in establishing a dedicated pilot-scale production facility are described hereafter…
Humans have enjoyed large-scale protection against many infectious and contagious diseases since 1796, when Edward Jenner first introduced a vaccination against smallpox by an active immunization technique. Vaccination has proved itself to be the most successful solution for preventing the occurrence of many infectious diseases that previously caused serious illnesses, post-recovery ailments, and even death (e.g., smallpox, diphtheria)…
Despite the existence of effective vaccines against Hepatitis B virus, the infection with it remains an important problem worldwide due to its association with hepatocellular carcinoma. Several procedures have been used to purify the Hepatitis B surface antigen (HBsAg) for immunization purposes. Immuno-purification using HBsAg-specific murine monoclonal antibodies (MAbs) has been one of the most successful strategies for such a purpose due to the high antigen selectivity (high affinity) of MAbs…
The biologics market, although difficult to estimate, is currently thought to be in excess of $20 billion. In recent years, the growth in the novel therapeutics market has continued to exceed all but the most optimistic of expectations. The number of products in early stage trials may already be over 1,000, with an estimated 40 or so additional products in the process of finally being released to the market. The biologics market is led by relatively few “blockbuster” drugs, but the breadth of novel products continues to expand. This has resulted in exciting times for clinicians but has resulted in concern related to the bottleneck of production capacities for these drugs, as well as the pressure from healthcare agencies to reduce the cost of goods…