Best Collaboration – 2016 BioProcess International Awards
WINNER: Puridify/GlaxoSmithKline * FibroSelect for Industrial Use
Puridify Ltd span out from University College London in 2013 to develop a step-change downstream processing technology for industrial biotherapeutic manufacture. The unique high capacity, high flowrate properties of FibroSelect dramatically reduce unit operation size relative to traditional packed beds. The ready-to-operate units reduce validation burden, improve process robustness and increase facility flexibility. Puridify required industrial quantities of cell harvest material only accessible through industrial collaborations. GSK and Puridifiy have been in a highly complementary collaboration for the past 12 months developing and evaluating the technology from microliter to 50L pilot scale and in the process have shared knowledge, industrial processing concepts and novel ideas. This initial collaboration has been successful in proving a 50-fold increase in purification productivity and has been extended for a further 18 months to drive towards full industrial scale purifying feed from >500L bioreactors.
In addition to purification productivity a number of other quantitative and qualitative benefits have been identified and center around processing flexibility, ease of use, speed of processing, reduction of unit operations, and most importantly, maximizing the productivity of existing and future facilities. FibroSelect offers the potential to address many of the advancements identified as critical to the development of the biopharmaceutical industry but requires in-depth and continuous support from major drug manufacturers to ensure development and market entry with a technology that really makes a difference.
G-CON/GEA Pharma Systems/Pfizer * The PCMM Consortium
To create the next generation of drug processing technologies and address the rapidly changing requirements of pharmaceutical drug manufacturers, Pfizer, GEA, and GCON Manufacturing formed a consortium to design and build a portable, autonomous manufacturing environment for continuous oral solid dosage production using GEA’s ConsiGma™25 system and G-CON’s modular POD system. The result — Portable, Continuous, Miniature and Modular (PCMM) Development and Manufacturing for Solid Oral Dosage forms— is a platform technology utilized in product development and commercial manufacture; a key innovative advantage is being able to use the same equipment throughout the entire product lifecycle.
Throughout the collaborative design process, the following innovative approaches were incorporated into the project: 1. Increased project speed significantly reduced project timelines for facility design and construction and the design of the customized air bearing and POD lifting system which allowed the PODs and process equipment to be positioned and installed into a grey space warehouse within one week upon receipt at the landing location. 2. Enhanced quality Integration of five process analytical technology sensor systems within the continuous wet granulation and continuous direct compression process equipment and integration of an advanced process control capability to integrate signals from process and PAT sensors into a real-time monitoring and control system. 3. Reduced overall project costs lower upfront investment cost compared to traditional facility design and build Approaches and faster depreciation as PODs can be depreciated as “equipment” in addition to lower energy
Pall Life Sciences/FloDesign * Disruptive Cadence Acoustic Separator
Pall Life Sciences and FloDesign Sonics (FDS) began an extremely close collaboration in 2015 to develop their existing acoustic wave separation (AWS) technology for continuous clarification of highly regulated biopharmaceutical products. Within one year time, the teamwork resulted in the commercialization of the Cadence™ Acoustic Separator, currently the only scalable single-use technology of its kind for cell culture clarification from process development through to large-scale drug manufacturing.
This disruptive, scalable technology takes advantage of single-use components with a small footprint, and can be applied for continuous clarification from process development through to large scale manufacturing. A drastic (up to 75%) reduction in the filtration area and buffer volume requirements has been noted by users, and process results have proven to be highly reproducible with consistent purity profiles. The platform is flexible for application with various types of biologic products, including recombinant therapeutic proteins and monoclonal antibodies, regardless of the variability in particulate concentrations or cell culture density, turbidity and viability.