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

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.

Technology Advances Streamline Bioprocessing

Jennifer Markarian is manufacturing editor of Pharmaceutical Technology.

Analyzing process and equipment data provides insights that can improve quality and productivity of pharmaceutical manufacturing.

Analytics Boosts Manufacturing Capabilities

The technology center is dedicated to developing greener, safer chemistries for manufacturing pharmaceutical raw materials and intermediates.

PharmaBlock Opens New Chemistry and Engineering Technology Center in Zhejiang, China

The new patented process results in uniform, scalable production and the ability to deliver cell cargo similar to natural exosomes/extracellular vesicles.

Orgenesis, ExcellaBio Announce Breakthrough Manufacturing Process for Bioxomes

Tackling process development early on can better optimize manufacturing processes for emerging therapies.

Optimizing Process Development for Emerging Therapies

Chris O’Callaghan is senior product manager at Innopharma Technology, Dublin, Ireland, ocallaghanc@innopharmalabs.com.

Ian Jones, PhD, is founder and CEO of Innopharma Technology and Innopharma College of Applied Sciences, Dublin

Caroline McCormack  is process laboratory manager at Innopharma Technology, Dublin, Ireland.

Luke Kiernan is a PhD student at the Technological University Dublin in Ireland.

Gavin Walker, PhD, is professor and director of the Synthesis and Solid State Pharmaceutical Centre at the University of Limerick in Ireland.

Gareth Clarke is Multieye Product Manager, Innopharma Technology, Dublin,Ireland

Advanced dynamic process control of a fluid-bed granulation process using PAT data improves product quality.

Self-Guided Control of a Fluid Bed Granulation Process

Agnes Shanley is senior editor of Pharmaceutical Technology.

As equipment evolves and use of PAT increases, DOE is becoming an integral part of upstream bioprocess development.


DOE Gains Ground in Biopharmaceutical Development

Elizabeth Joseph is research scientist II, BioPharma Solutions at Baxter Healthcare Corporation.

The author provides an overview of common residual moisture methods for lyophilized drug products and key points to consider during method selection and method development.

Residual Moisture Determination in Lyophilized Drug Products

The partners have developed a scalable, cost-effective purification process for adeno-associated viruses.

GE Healthcare, CPI, and Cobra Biologics Introduce New AAV Purification System

Systems-based pharmaceutics case studies, challenges, and new uses were discussed at PSE’s Advanced Process Modeling Forum.

Process Modeling Tools Find Use in Bio/Pharma R&D and Manufacturing

CPI, the University of Strathclyde, GSK, and AstraZeneca Collaborate on a continuous direct compression digital twin for pharmaceutical formulation optimization. 