Development

Eric Sanchez is a senior consultant of Integra Continuous Manufacturing Systems with a special focus on the implementation of continuous manufacturing methods. He joined the firm after a successful 31-year career with Janssen Pharmaceuticals.

Fernando J. Muzzio, PhD, is distinguished professor of the School of Engineering at Rutgers, The State University of New Jersey, Piscataway, NJ 08855. Dr. Muzzio is a member of 

 editorial advisory board and President of Integra Continuous Manufacturing Systems.

Articles

Advanced manufacturing technologies are available, but challenges need to be addressed.

 Reshoring Pharmaceutical Manufacturing to the US: Can We Do It?

Jennifer Markarian is manufacturing editor of BioPharm International.

Collaboration between equipment suppliers and users is leading to innovation and optimization in biopharmaceutical manufacturing.

Equipment Suppliers and CDMOs Advance Process Development

The launch of HiScreen Fibro PrismA, the company’s newest product for early mAb purification process development strengthens Cytiva’s new fiber-based Protein A platform.

Cytiva Advances Fiber Chromatography Technology with New Launch

The new facility, to be located in Boston, MA, will contain experimental and analytical equipment for viral vector and advanced therapy process development and will expand the CDMO’s manufacturing capacity.

Fujifilm Corporation to Invest $40 Million into New Viral Vector and Advanced Therapy Facility

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

A holistic approach to validation and quality assurance is essential.

Prepping Fill/Finish Systems to Ensure Quality Output 

Agnes Shanley is senior editor of Pharmaceutical Technology.

As biopharmaceutical process development advances, a more collaborative and knowledge-based approach, driven by better analytics and high-throughput system integration, is reducing the risk of failure.





Bringing Bioprocess Development into Focus

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

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.

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.