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. [...]
Improvements throughout the pipeline bring greater biologic yields, as well as higher quality. by Raymond E Peck, CEO of VxP Biologics Improvements throughout the pipeline bring greater biologic yields, as well as lower costs. Bioprocessing is the production of natural or genetically manipulated cells (or other organic parts). In the field of biologic pharmaceuticals, bioprocessing [...]
The creation, production and storage of viral vectors all pose highly unusual challenges. by Susan Thompson, Technical Director at VxP Biologics Traditional viral vaccines use attenuated or inactivated forms of viruses to trigger and “train” the body’s immune responses. In recent years, however, pharmaceutical developers have also begun to use viruses as vectors to deliver [...]
Advances in Biological Safety Level 3 technology offer advantages for agile biologic developers. by Raymond E Peck, CEO of VxP Biologics Many types of biologics include live populations of organisms, some of which may be highly infectious in active form. Vaccines, in particular, often contain deadly bacteria and viruses in live but attenuated forms. The [...]
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) [...]
As the biologics market expands, developers need support from expert contractors. by Raymond E Peck, CEO of VxP Biologics A growing number of pharmaceutical development companies are partnering with contract manufacturing organizations (CMOs) to meet the global demand for biologics. This investment comes with good reason: as of 2016, the global biopharmaceutical market was valued [...]
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 [...]
Although lyophilization (freeze-drying) is a costly, time-consuming process, it offers a number of major advantages over simpler dosage forms. by Raymond E Peck, CEO of VxP Biologics Tablets and capsules can create problems for patients with nausea or difficulty swallowing; syringes can carry risk of infection; and even certain drugs administered from vials can take [...]
