Current Techniques in Monoclonal Antibody Development
As the complexity of mAbs continues to grow, developers explore the potential of new techniques and expression systems. The development of mAbs (monoclonal antibodies) has come a long way since 1986, when the first mAb, Orthoclone OKT3, received approval for clinical use. Over the past 30 years, mAb production has [...]
Solid Oral Dosage Vaccine Development and Manufacturing
Challenges of adapting vaccines for oral administration remain significant, but emerging techniques promise greater flexibility and efficiency. Pressures to streamline development and production continue to ramp up in many areas of the pharmaceutical industry. This is particularly true in the field of solid oral dosage forms for vaccines, which now [...]
Emerging Trends in Sterile Fill and Finish Technology
New packaging materials, disposable devices and automated systems offer enhanced performance. The core goals of an aseptic fill and finish process have remained essentially the same for more than two decades. Manufacturers of sterile drugs seek to maintain uncontaminated conditions throughout the packaging process, performing the filling and finishing stages [...]
Prefilled Syringe Manufacturing for Biopharmaceuticals
Regulations in this sector are rapidly tightening, but advances in materials and manufacturing techniques can help manufacturers meet rising expectations. As biopharmaceutical formulations capture ever-greater market share, demand for self-administered delivery systems has fueled rapid advances in the manufacturing of prefilled syringes. With increasing volume have come innovations in packaging [...]
3 Challenging Complexities of Preclinical Toxicology Studies
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 [...]
7 Critical Reasons to Invest in Pharmaceutical Analytical Services
Manufacturing competencies aren't the only reasons to partner with a contract manufacturing organization (CMO). Throughout every stage of your pharma development process, analytics can help increase efficiency, raise margins, and keep you ahead of your competition in all seven of the following ways: 1. Validation programs characterize useful compounds, [...]