01.11.21 -- Implementing Improved Analytical Methods To Support Vaccine Quality

Product launches see pharma and biotech companies handing over drugs with incredible value, both commercially and to the health of patients globally, to contract packaging partners. Many of the virtual and small biotech companies simply lack the infrastructure necessary to handle packaging, and large pharma companies tend to outsource as contract service providers offer experience and significant surge capacity for short or extended periods of time.

Optimizing and maintaining tablet compression tooling surely brings challenges. Poorly performing tools is a challenge all pharmaceutical manufacturers must conquer. This blog reviews how to reduce common compression issues during production and eliminate tooling downtime, and then offers tips on how to extend the life of your tablet compression tooling.

Bioavailability challenges are among the toughest problems faced by today’s formulators. Most of the prospective drugs in pharmaceutical pipelines today have low solubility, which means the active therapeutic ingredients can’t be absorbed when patients take them orally. This paper gives an overview of obstacles to bioavailability and summarizes the Lonza technology selection process.

The more efficient your API synthesis, the lower your cost of goods. The author shares his tricks of the trade for route selection, equipment choice, manufacturing techniques, and more.

Here we report on high-performance host cell residual DNA extraction and quantitation using a streamlined and high-throughput semi-automated workflow.

Biomanufacturing is trending toward higher numbers of monoclonal antibody (mAb) projects and smaller batch sizes, with production of most mAbs below 100 kg/yr. These trends are fueling demands to screen more clones faster and improve the efficiency of process development (PD). Read how the Fibro PrismA unit provides a time advantage with comparable recovery and product quality attributes to resin-based columns.

Due to the increasing complexity of today’s API molecules, formulation problems are arising with greater frequency, delaying development and burdening developers with unanticipated and heavy costs.

To prevent delays and costly issues during molecular development, it is important to understand potential mechanisms of increased absorption with lipid formulations and the appropriate screening tools.

Lengthy early development timelines are common across new and emerging biotech companies for a multitude of reasons. Striking the right balance of speed, quality, risk, and investment allows you to shorten timelines and work with efficiency. Strategies adopted for the rapid development of a simple, yet flexible, format prove beneficial.