Moderator: Anna Brown, Conference Producer, Informa. Featuring: Gareth Jones, Vice President of Sales EMEA, PhenomeX. In this interview from BPI Europe in May 2023, Gareth Jones, Vice President of Sales EMEA, PhenomeX discusses accelerating biological research, using optoelectric positioning and microfluidics to scale down volumes of bioreactors, and more. Watch the full interview below.
Moderator: Anna Brown, Conference Producer, Informa. Featuring: Christian Witz, CEO, Sim Vantage. In this interview from BPI Europe in May 2023, Christian Witz, CEO, Sim Vantage discusses its use of principle simulations of bioreactors, the advantages of having digitalized processes, and more. Watch the full interview below.
Establishing a cell culture process across different scales and models of bioreactors involves maintaining constant scale-independent parameters such as pH, temperature, and dissolved oxygen (DO). However, nonlinear and scale-dependent criteria (impeller agitation and gas flow rates) are adjusted on the basis of multiple normalized engineering parameters to accommodate the geometrical and design differences among bioreactors (1–3). Normalized engineering approaches for scaling parameterization often are based on the shear generated by impeller speed and gas flow rates. Kinetic energy transmitted into…
In a November 2022 webinar, Stuart Gibb (scientific strategy lead from Terumo Blood and Cell Technologies) explained the benefits of hollow-fiber bioreactors (HFBRs) for cell therapy. They are suitable for both adherent and suspension-adapted cells. Terumo’s bioreactors are designed to enable flexible feeding and waste-management strategies, which are key features that can facilitate optimal cell growth. The Presentation Gibb presented Terumo’s Quantum Flex HFBR platform, which the company launched in September 2022. Bioreactors for the Quantum Flex platform come in…
Spectroscopic sensors are powerful tools for bioprocess monitoring within the process analytical technology (PAT) initiative of the US Food and Drug Administration (FDA). The PAT framework includes process understanding based on scientific background with the aim of monitoring and controlling critical process parameters (CPPs) that influence critical quality attributes (CQAs) of final biological products. The driving force for PAT implementation is a need to realize consistent product quality, process intensification, and real-time manufacturing control (1, 2). Using real-time spectroscopic measurements…
During a May 2022 Ask the Expert presentation, Ivana Petrović Koshmak (head of upstream process development at BIA Separations, part of Sartorius) highlighted the gene- therapy industry’s need for fast, reliable analytics that work with both up- and downstream samples. High-performance liquid chromatography (HPLC) methods can fulfill that need, but process development (PD) scientists would need to account for the complexity of bioreactor samples to make such methods feasible for end-to-end analytics. Koshmak described a novel instrument that is designed…
The past couple of decades have witnessed significant advances in upstream bioprocess technologies and approaches. Since its establishment, BPI has been a facilitator of discussion in both print and professional conferences, as well as in webcasts and news online. To mark the 20th anniversary of the publication, we surveyed articles published over the past two decades and found hundreds that highlight significant advances in both emerging and established themes in biopharmaceutical production: • “hardware” and assets (e.g., analytical instrumentation, bioreactors,…
The number of cell and gene therapies in different phases of development is increasing. The industry currently needs to increase commercial good manufacturing practice (GMP) capacity to keep up with current and future demands. Cell and gene therapy scale-up from clinical to commercial capacity levels can reduce cost of goods and thus price per dose. An optimized bioprocess facilitates scale-up from hundreds (clinical scale) to thousands of doses (commercial scale). Different approaches for increasing scale can be taken. For example,…
Pressure vessels are enclosed containers used to contain liquids, vapors, and gases at pressures that are significantly higher or lower than the ambient pressure of their surroundings. Equipment such as bioreactors, holding tanks, mixing tanks, separators, and heat exchangers all are examples of pressure vessels. As such, they form an integral part of biopharmaceutical manufacturing. Apart from pressure containment itself, a key challenge in building pressure vessels is making them meet the high purity and cleanability requirements of bioprocessing. As…
The recent outbreak of the severe acute respiratory syndrome coronavirus (SARS-CoV-2) led to the development of different vaccine approaches worldwide to prevent the coronavirus disease 2019. The first registered vaccine on the market was the Sputnik V product based on two recombinant adenoviral vectors (Ad5 and Ad26). The product has received approval in 70 countries by several national and regional regulatory authorities, meanwhile. Though the availability of SARS-CoV-2 vaccines in most developed countries is not an issue any longer, other…