Development

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

Articles

Modeling the manufacturing process benefits both development and operations. 

GSK Pilots Digital Twin for Vaccine Manufacturing 

The US federal government awarded new funding to the National Institute for Innovation in Manufacturing Biopharmaceuticals, including funding under the American Rescue Plan that will be used to advance vaccine manufacturing. 

NIIMBL Receives Federal Funding for Biopharmaceutical Manufacturing Projects

The new lab near Continuus Pharmaceutical’s current facilities in Massachusetts will expand the company’s process development capabilities to high-potency drugs.

Continuus Pharmaceuticals Opens Process Development Lab

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

Ajay Pazhayattil*, M.Pharm, DBA, Ajay.Pazhayattil@capcium.com, is vice-president, Scientific and Regulatory Affairs at Capcium.

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

Intensified and distributed manufacturing approaches create flexible, local capacity.