Development

Articles

The collaboration continues as the companies design bioprocess impurity reagent sets to detect residual HCP from HEK 293 cells. 

Gyros Protein Technologies and Cygnus Technologies to Develop Impurity Reagent Sets

Susana Saldanha, PharmD, is formulation development scientist at Hovione.

Beatriz Fernandes, MSc, is a formulation development scientist at Hovione

João Ventura, PhD, is director of Technology Development and Licensing at Hovione Technology.

Particle performance in a DPI can be optimized by fine-tuning the formulation and manufacturing process parameters.

Spray Drying as an Enabling Technology for Inhalation Drug Delivery

Sanjay Sharma is vice-president and head of technology transfer at Lupin Pharmaceuticals

Amol Galande is senior manager of the process development laboratory at Lupin Pharmaceuticals

Marzena Ingram is senior manager, quality and compliance at Eurofins CDMO. She led and hosted several cGMP audits, and has diverse quality assurance and technical operations experience. 

Robert Rhoades is managing partner at Validant.

A data-driven strategy can assess the quality of legacy drugs developed before 2011 process-validation requirements were established.

Assessing Legacy Drug Quality 

SP Scientific Products’ SP Hull LyoStar 4.0 R&D freeze dryer supports rapid freeze-dry cycle development, optimization, and process scale-up.


New Pilot-Scale Lyophilizer Aids Drug Development

What can the biopharma industry learn from its rapid response to the COVID-19 pandemic?

Process Development Improvements Post-Pandemic

Well-defined studies are crucial to effective process development

Common Challenges in Cross-Functional Process Development

Jennifer Markarian is manufacturing editor of Pharmaceutical Technology.

Intensified and distributed manufacturing approaches create flexible, local capacity.

Advanced Manufacturing Technologies Shift Outside the Box

Jennifer Markarian is manufacturing editor of BioPharm International.

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.

Building Up End-to-End Continuous Manufacturing

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.

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

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

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