Process Development

Well-defined studies are crucial to effective process development

Intensified and distributed manufacturing approaches create flexible, local capacity.

Continuus Pharmaceuticals is building the first GMP facility using integrated continuous manufacturing technology for end-to-end production of small-molecule APIs and finished dosage forms.

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

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

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.

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.

A holistic approach to validation and quality assurance is essential.

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.

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.

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.

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

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.

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

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

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

Ensuring 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.

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

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

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

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

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

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

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

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.

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

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

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

In this article, experts discuss the fundamentals of dissolution testing and highlight the challenges that are surfacing as a result of the increasing numbers of poorly soluble molecules entering the development pipeline.