Process Development

Stimple, Samuel D.; Wood, David

doi:10.1002/9781118940648.ch12

Cited by 1 publication

(2 citation statements)

References 65 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…This column utilises the high affinity of the Fc region of mAbs with protein A ligand, yielding purities more than 98%. While this recovery is largely dependent on column loading conditions, these parameters can be optimised at bench scale before an engineering batch is performed (Stimple & Wood, 2017). The use of protein A chromatography had emerged alongside protein G during the start of the biologics industry.…”

Section: Downstream Processingmentioning

confidence: 99%

“…Pre-treatments to clarification have also been under development for a significant period. While the use of pre-treatments is far simpler to implement that continuous chromatography, there are many issues associated with mAb interaction and protein loss (Stimple & Wood, 2017). Due to the sensitivity of mAbs to salts, pH and coagulants present, adding flocculants may significantly reduce recoveries (Daniel Dixon, 2018).…”

Section: Single Use Technologymentioning

confidence: 99%

See 1 more Smart Citation

UQ eSpace

Chai¹

View full text Add to dashboard Cite

Patheon Biologics, part of Thermo Fisher Scientific in Brisbane has provided opportunities for Chemical and Biological engineering students to intern as operators for ENGG7290. Students are provided experience within biologics manufacturing for their placement semester within the Bachelor of Engineering/ Masters of Engineering (Hons.) Program at UQ. This document presents the progress on training and projects given throughout the internship. Additionally, the responsibilities and activities undertaken throughout the placement at Thermo Fisher have been described through various figures. Finally, details about professional developments and learnings from events that occurred during placement are provided in the form of reflections, linked toward the competencies expected by graduate engineers outlined by Engineers Australia. Training was performed across all three operations departments; Media and Buffer Preparation, Upstream Processing and Downstream Processing These rotations have afforded a detailed view of the biologics manufacturing process, starting from the very beginning of a project to final operations. Key equipment, processes and activities required throughout manufacturing were operated or performed, with a significant amount of activities verified to be performed as a competent employee. Projects given throughout the duration of placement were completed or are under investigation, relating towards all aspects of operation. The first project was the completion of a newly developed Sample Configurator that automates sample document generation, used throughout Operations, Quality Control, Process Engineering and Quality Assurance departments. This tool has seen almost complete use with Process Engineering and Quality Control, and reduced overall documentation time by up to 5 hours. The second and largest project worked upon during placement involved an investigation into optimising buffer preparation. This resulted in a sitewide study into buffer usage, resulting in a proposal to consolidate buffer containers. This consolidation is set to save $20 000 to $100 000 per process operated onsite, and save up to 1 week of operational time, and 2 to 4 weeks of Quality Assurance review. Associated risks and additional observations have also been outlined within this report for further improvements to operations. The final project, involved the preliminary implementation of a new Inline Conditioning skid set to reduce the overall work required within buffer preparation. The impact the Inline Conditioning skid was estimated to reduce overall space consumption by at least 40%, allowing for significantly more operations to occur. Additionally, preliminary analysis into optimal stock concentrates was studied with further recommendations provided for future investigation. Development of Engineering Australia Competencies has been split between Engineering Conceptual Knowledge and the Development of Professional Attributes. A lack of Engineering Conceptual Design has been identified due to the lack of design work avail...

show abstract

Section: Downstream Processingmentioning

confidence: 99%

Section: Single Use Technologymentioning

confidence: 99%

UQ eSpace

Chai¹

View full text Add to dashboard Cite

show abstract

Process Development

Cited by 1 publication

References 65 publications

UQ eSpace

UQ eSpace

Contact Info

Product

Resources

About