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University of Strathclyde - Articles and news items
Issue 3 2013, PAT & QbD / 13 June 2013 / Payal Roychoudhury, formerly AstraZeneca and Ronan O’Kennedy, Fujifilm Diosynth Biotechologies and Jim Faulkner, GlaxoSmithKline and Brian McNeil & Linda M. Harvey University of Strathclyde
Biopharmaceutical companies are constantly evaluating new methods for mammalian cell line development that offer benefits such as shorter time lines, improved consistency, higher monoclonal antibody (mAb) production, better genetic stability and increased flexibility. Each of these advantages extends a potentially large cost benefit to companies as their recombinant protein products move from development into the clinic, and finally on to commercial launch. In this context, sophisticated chemometric software packages show great potential in enhancing process knowledge and providing optimised control of these complex and challenging processes.
A Nobel Prize winner has been awarded an honorary degree by the University of Strathclyde…
A pioneering research institute to drive forward the search for new and better medicines to open…
The majority of active pharmaceutical ingredients (APIs) are produced by crystallisation and so the phenomenon of polymorphism, whereby an organic molecule can adopt more than one crystalline form (Figure 1 opposite), is of considerable importance when trying to achieve consistent product quality during the manufacture of pharmaceutical solids and solid dosage forms. Although morphology and particle size-distribution are important solid-state characteristics, the uncontrolled occurrence of multiple physical forms (polymorphs, solvates, salts, co-crystals or amorphous) of an API can have significant effects on the performance of the material during processing, manufacture, storage and administration. For example, the solubility difference between some polymorphs has been shown to be over four times that of the least soluble form1 and can vary by significantly more for amorphous forms2.
The manufacture of sterile products attracts the greatest regulatory scrutiny of all product types, since manufacturing failures can be fatal and manufacturers are required to utilise the most robust sterilisation method possible to limit the probability of this occurring. However, aseptic preparation, which is the last resort manufacturing method, continues to be employed since for sensitive products this is the only feasible route. Aseptic preparation has always suffered from the potential for undetected, or undetectable, microbial ingress occurring during the manipulation of sterile components. The implementation of isolator systems have provided an advance over standard clean rooms technologies and the weakest link of aseptic preparation is getting stronger.
Issue 1 2006, Past issues / 2 February 2006 / Professor David Littlejohn, Head of the Department of Pure and Applied Chemistry at the University of Strathclyde, Director of CPACT at the University of Strathclyde
There can be no doubt that the FDA’s initiative on Process Analytical Technologies (PAT) has had an enormous impact on the pharmaceutical industries. However, the emergence of ’born again‘ PAT devotees in pharma companies has caused mild amusement in other industries where on-line analysis has been an integral part of process monitoring and control for a long time.
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