Before a drug can proceed to the clinical trial stage, its developer must first pinpoint its likelihood of harming people by performing in vitro and in vivo toxicological studies. These studies involve a number of technical complexities, of which the following three are particularly challenging: 1. In vitro toxicology studies provide only limited insight [...]
The field has advanced considerably in recent years, but a number of key challenges remain. by Raymond E Peck, CEO of VxP Biologics Because injectable biologics are introduced directly into the body’s tissues, these formulations must be extraordinarily free from contamination of every kind. This requirement sets a high bar for the manufacturing of injectables. [...]
This powerful technique enables rapid identification and sorting of cells, streamlining the manufacture of many biologic pharmaceuticals. by Raymond E Peck, CEO of VxP Biologics In the manufacture of many types of biologics, flow cytometry is a crucial tool for identifying, analyzing and sorting cells. This technique can provide a wide range of data points [...]
The Vero platform’s upstream and downstream processing stages are designed for maximum efficiency and safety, as well as purity of the final product. Despite many recent advances in vaccine development technology, the actual process of bringing new vaccines to the clinical trial stage often remains cumbersome and slow. Even the most elaborate recombinant technologies and vector systems may not integrate smoothly into an existing manufacturing pipeline, and inefficiencies and safety issues may emerge at any step of the process.
To help accelerate MCM development, VxP Biologics has developed its Advanced Development and Manufacturing of Antibody Technologies (ADAMANT) platform. This platform integrates cell libraries, region design and selection techniques, and formulation standards into a high-throughput production format. By optimizing and standardizing antibody design and production, ADAMANT helps biologic developers bring new antibody candidates to the clinical trial stage more rapidly.
This cell development platform has proven effective in the creation of a number of viral vaccines. by Susan Thompson, Technical Director at VxP Biologics Recent years have witnessed a significant amount of innovation in technologies for the development of novel vaccines. These technologies include new vector systems for delivering attenuated vaccines, recombinant technologies for generating [...]
Emerging technologies offer exciting opportunities for the development of novel therapies. by Susan Thompson, Technical Director at VxP Biologics Although commercial sales are certainly a desirable target for pharmaceutical development, they’re far from the only reason to invest in new products. In a number of fields, pharma developers are partnering with contract manufacturing organizations (CMOs) [...]
Although still expensive to develop and produce, large molecules are rapidly taking over. by Susan Thompson, Technical Director at VxP Biologics For most of the previous century, much of pharmaceutical research focused on the development of small-molecule “blockbuster” drugs, which treated a wide variety of diseases for a great number of patients, and could thus [...]
Monoclonal antibody approval success rates vary widely, but are on the increase overall. by Raymond E Peck, CEO of VxP Biologics The human monoclonal antibody (mAb) sector has witnessed tremendous growth since its inception in the early 1980s. Despite a rocky start, new technologies in molecule generation spurred rapid development throughout the 1990s; and in [...]
Growth continues, but logistical and regulatory hurdles limit worldwide supplies. by Susan Thompson, Technical Director at VxP Biologics The global market for sterile injectables continues to expand at an impressive rate. In 2015, this market was valued at $299.7 billion; and its compound annual growth rate (CAGR) is projected at 6.9 percent, at least through [...]