Newsletter | January 11, 2021

01.11.21 -- Implementing Improved Analytical Methods To Support Vaccine Quality

 
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Featured Editorial
Industry Insights
Supporting The Rapid Launch Of Pharmaceutical And Biopharma Products: A Contract Packaging Perspective

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.

How To Minimize Production Downtime By Maintaining Your Tablet Compression Tooling

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.

Technology Selection To Enhance Bioavailability

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.

Insight From An Expert: A Chemist’s Secrets To Efficient API Scale-Up

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.

High-Performance Extraction And Quantitation Of Host Cell Residual DNA

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

Automated High-Throughput mAb Purification Using Fibro Technology

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.

Anticipating The Formulation Challenges Of Complex Molecules

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.

Lipid Formulations To Enhance Bioavailability In Early Development

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.

Shortening The Timeline To First-In-Human (FIH) Clinical Dosage Form For Oral/Injectable Delivery

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.

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What COVID-19 Vaccines Teach Us About All Tech Transfers
 

Are there lessons learned and best practices from the COVID-19 vaccine efforts you can apply to tech transfers of your own projects — be they small molecule, biologics, or cell and gene therapies? View the on-demand version of OP-Virtual from our discussion on November 4, 2020, on what we’ve learned thus far and how to transfer that knowledge to your projects.