Drug Development

Articles

GMP agents report on old products, aseptic violations, and unexpected emotions.

Out of Control

Operational excellence awaits, but only if you can implement PAT successfully.

Managing the risks of PAT

The source of a problem reveals itself after some investigation, or it may crash down on you.

Detective Work

When applied as part of a structured approach, predictive modelling can provide deep process and product understanding, and can enable true, continuous process validation as envisioned by ICH guidelines.

Predictive modelling: putting ICH guidelines to work in process validation

PAT guidance has been available from FDA for more than 4 years, but there have been no apparent breakthroughs in large-scale upstream production. Will companies consider using on?line chromatography to change this?

PAT: HPLC on the horizon?

Tim Freeman is Managing Director of powder characterization company Freeman Technology for whom he has worked since the late 1990s. He was instrumental in the original design and continuing development of the FT4 Powder RheometerÂ® and through his work with various professional bodies, and involvement in industry initiatives, is an established contributor to wider developments in powder processing.Tim has a degree in Mechatronics from the University of Sussex in the UK. He is a mentor on a number of project groups for the Engineering Research Center for Structured Organic Particulate Systems in the US and a frequent contributor to industry conferences in the area of powder characterisation and processing. A past Chair of the American Association of Pharmaceutical Scientists (AAPS) Process Analytical Technology Focus Group Tim is a member of the Editorial Advisory Board of Pharmaceutical Technology and features on the Industry Expert Panel in European Pharmaceutical Review magazine. Tim is also a committee member of the Particle Technology Special Interest Group at the Institute of Chemical Engineers, Vice-Chair of the D18.24 sub-committee on the Characterization and Handling of Powders and Bulk Solids at ASTM and a member of the United States Pharmacopeial (USP) General Chapters Physical Analysis Expert Committee (GC-PA EC).

Enshrined in the concept of Quality by Design is the premise that optimized pharmaceutical manufacturing requires detailed understanding of products and processes. With this in mind, many benefits can be achieved by combining modern powder characterization techniques with real processing experience.

Quantifying experience in powder processing

Justin Neway, PhD, is executive vice-president and chief science officer at Aegis Analytical Corporation.

To implement QbD and reduce business risks, teams should begin QbD collaboration early during process development.

Bridging the Development–Manufacturing Gap to Achieve QbD and PAT

GMP experts act fast to resolve some unusual and difficult problems.

Quick Solutions

Carl Jones is a production manager (scale-up) at Protherics UK.

Aline Denton is a compliance manager at Protherics UK, Blaenwaun, Ffostrasol, Llandysul, Ceredigion, Wales, UK, SA44 5JT, tel. +44 1239 851 122.

The authors examine the challenges of integrating a large-scale chromatography and nanofiltration process for purification of a polyclonal antibody.

Integration of Large-Scale Chromatography with Nanofiltration for an Ovine Polyclonal Product

Readers give advice on their best approach to handling (batch) rejection

Process and Scaling