Drug Development

Alberto Santagostino is senior vice-president and head of cell and gene technologies at Lonza Pharma and Biotech. 

Articles

Contract partners must help innovators, especially smaller and virtual companies, consider manufacturability as early as possible in development. This requires focusing on technical and operational performance, as well as cost. 

Using the ‘Cubic Effect’ to Drive Cell and Gene Therapy Commercialization

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

Emphasizing the need for senior management to take cGMP compliance seriously, the agency pointed to “improvisational” validation procedures, lack of compliance with written procedures, as well as  inadequate process control, root cause analysis, and corrective and preventive action (CAPA) in its warning letter.

FDA cites repeated, fundamental cGMP issues in its warning letter to Torrent Pharmaceuticals

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

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. 

UK Collaboration Uses a Direct Compression Digital Twin to Speed OSD Formulation

Felicity Thomas is the former Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

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.


The Fundamentals of Dissolution Testing

As tests at GSK have shown, integrating powder testing into overall operations can optimize process understanding, and with it, raw material selection, equipment design, and process development.

Process and Scaling