Chromatographic operations are identified as critical steps in a monoclonal antibody (mAb) purification process and can represent a significant proportion of the purification material costs. The optimisation of chromatography equipment sizing strategies is therefore crucial to improve the cost-effectiveness of mAb manufacture. In this work, a mixed-integer linear programming model (MILP) was developed to determine the optimal chromatography column sizing decisions, so as to minimise the cost of goods per gram (COG/g) of the whole mAb manufacturing process. Modelling challenges related with non-linearities involving the multiplication of decision variables were addressed by the use of linearisation techniques allowing the resulting model to determine global process performance metrics (e.g. chromatography processing time, COG/g). The application of the MILP model to an industrially-relevant case study combined with the use of visualisation methods proved to be a valuable tool to explore the characteristics of the optimal sizing strategies across different scenarios and to facilitate decision-making.
The impact of upstream and downstream process fluctuations in bioprocesses becomes more pronounced during technology transfer of pilot scale processes into large-scale facilities. Mismatches in equipment sizes upon scale-up combined with process fluctuations can lead to discarding expensive product. Understanding and predicting the root causes of product loss is critical to determining the necessary facility modifications required to meet manufacturing targets. In this work, a decision tree classification method, CART (classification and regression tree), was used to interrogate stochastic Monte Carlo simulation datasets that mimic batch fluctuations in industrial biopharmaceutical batch processes. The resulting binary decision tree not only reveals the impact of process fluctuations on product mass loss but also extracts a series of if-then rules on the critical combinations of factors that lead to unacceptable mass loss levels. The decision tree analysis therefore allows rapid prediction of the likelihood of facility fit issues as well as the batch characteristics that result in product loss.
I am unaware of any textbook which provides such comprehensive coverage of the field and doubt that this work will be surpassed in the foreseeable future, if ever!' From the foreword by Robert C. Moellering, Jr., M.D, Shields Warren-Mallinckrodt Professor of Medical Research, Harvard Medical School, USA Kucers' The Use of Antibiotics is the leading major reference work in this vast and rapidly developing field. More than doubled in length compared to the fifth edition, the sixth edition comprises 3000 pages over 2-volumes in order to cover all new and existing therapies, and emerging drugs not yet fully licensed. Concentrating on the treatment of infectious diseases, the content is divided into 4 sections: antibiotics, anti-fungal drugs, anti-parasitic drugs and anti-viral drugs, and is highly structured for ease of reference.Within each section, each chapter is structured to cover susceptibility, formulations and dosing (adult and paediatric), pharmacokinetics and pharmacodynamics, toxicity and drug distribution, detailed discussion regarding clinical uses, a feature unique to this title. Compiled by an expanded team of internationally renowned and respected editors, with a vast number of contributors spanning Europe, Africa, Asia, Australia, South America, the US and Canada, the sixth edition adopts a truly global approach. It will remain invaluable for anyone using antimicrobial agents in their clinical practice and provides in a systematic and concise manner all the information required when treating infections requiring antimicrobial therapy. Kucers' The Use of Antibiotics is available free to purchasers of the books as an electronic version on line or on your desktop: It provides access to the entire 2-volume print material It is fully searchable, so you can find the relevant information you need quickly Live references are linked to PubMed referring you to the latest journal material Customise the contents - you can highlight sections and make notes Comments can be shared with colleagues/tutors for discussion, teaching and learning The text can also be reflowed for ease of reading Text and illustrations copied will be automatically referenced to Kucers' The Use of Antibiotics
Thank you for visiting our website. Would you like to provide feedback on how we could improve your experience?
This site does not use any third party cookies with one exception — it uses cookies from Google to deliver its services and to analyze traffic.Learn More.