Development

Articles

Two FDA-funded projects at RCPE will look at real-time monitoring and control of drug tablet coating and developing a digital twin for drug production control.

RCPE Awarded FDA Funding to Develop Next-Generation Technology

Lucelys Caton is a technical service scientist with Gaylord Chemical Company.

Ashley Jones is analytical chemist with Gaylord Chemical Co, LLC.

Andrew Johnson is analytical specialist with Gaylord Chemical Co, LLC.

Dimethyl sulfoxide is increasingly used in high-risk parenteral and medical device applications that must be manufactured as sterile products in their finished form. A study evaluated the effects four sterilization techniques have on the product quality of this ingredient. 

Suitable Sterility Methods for Dimethyl Sulfoxide USP, PhEur

The award will help a bioanalytics startup commercialize instrument technology for pharmaceutical antibody manufacturers.

SBIR Awards $1.4-Million Grant to Accelerate Antibody Manufacturing Technology 

Esra’a Albarahmieh is associate professor, Pharmaceutical Chemical Engineering department of the School of Applied Medical Sciences, German Jordanian University.

Mohammad Khanfar is associate professor, Pharmaceutical Chemical Engineering department of the School of Applied Medical Sciences, German Jordanian University.

Emad Alzubi is instructor and workshop manager at the Industrial Engineering department of the School of Applied Technical Sciences, German Jordanian University.

This study suggests that using a simple centrifugal method can produce a natural polymer-blend molecule that can successfully be used as an oral delivery mechanism for poorly soluble drugs. 

Fabrication Modulation of Zein-based Fibers for Oral Delivery of Hydrochlorothiazide

The company has begun development of a 3D bioreactor for the cGMP production of extracellular vesicle exosomes.

Rigenerand Develops 3D Bioreactor for Extracellular Vesicle Exosomes Production

The company now offers its CONFIDENCE virus clearance services to support validation of viral clearance processes.

Sartorius Stedim Biotech Launches Consultancy Services for Viral Clearance Validation

This latest round of funding adds 14 new technology projects, workforce development, and Global Health Fund projects to NIIMBL's portfolio.

NIIMBL Funds Projects with $10 Million for Advances in Biopharma Manufacturing Innovation

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Ensuring the quality of data in process monitoring and control systems starts in process development phases. 

Building Data Quality In Generates Quality Data Out

Experience, communication, collaboration, transparency, planning, and prioritization contribute to success.

Ensuring Smooth Tech Transfer of Bioprocesses to Outsourcing Partners

Bioprocessing advances improve product yield, cut costs, and streamline integration between upstream and downstream processes.

Process Development