BioProcess International European Summit 2017 Highlights

Last week, over 850 bioprocessing professionals gathered in Amsterdam for BioProcess International European Summit 2017. Attendees moved between the exhibition hall featuring over 275 companies and nine streams covering upstream and downstream processing, cell line, vaccine manufacturing, viral safety and industry 4.0.

After a day of networking and agenda sessions, what better way to relax than a pre-King’s Day celebration with beer, gin, burgers, a DJ and LOTS of orange.

Watch some of the highlights from the event above and watch out for the full interviews with key speakers coming soon.

Sourcing raw materials for cell therapy manufacture – Dieter Hauwaerts, Celyad

‘Start working on raw materials early on’ – for Dieter Hauwaerts, Vice President of Operations at Celyad, the way to combat one of the biggest challenges in cell therapy manufacture is clear.

Limited availability of raw materials is a major issue for large scale manufacture of new therapies, but planning well in advance can help mitigate it: ‘In process development, take into account the quantity and quality of raw materials you will need in a clinical stage or commercial manufacturing process and build good relationships with suppliers.’

However, even with the necessary raw materials, Hauwaerts still sees issues with ‘the way we can manufacture products in a reliable and consistent way’, though he hopes that in 2017 automation will begin to negate this.

Watch the full exclusive interview with Hauwaerts – filmed at Cell Therapy Manufacturing & Gene Therapy Congress 2016 – above or here.

Continuous or intensified bioprocessing? The gold standard for improved productivity

by Nick Hutchinson

Process intensification and continuous biomanufacturing continue to attract a lot of interest within the biopharmaceutical industry as method that can increase productivity and make the most efficient use of production assets.

I interviewed Dr Gerben Zijlstra, formerly of DSM Biologics and the first named inventor on the patent for the XD® (Concentrated Fed-Batch) Technology. He now designs and implements continuous process platforms for biomanufacturers around the world for Sartorius Stedim Biotech.

What is the difference between intensified and continuous bioprocessing?

GZ: A fully continuous biomanufacturing process consists of interconnected continuous unit operations, without intermediate holding tanks, through which the product travels into the containers for Drug Substance in a seemingly constant flow.

Continuous unit operations represent an extremely intensified form of processing and have short downtimes relative to the amount of time they are used for production. A fully continuous biomanufacturing process might have a perfusion bioreactor coupled to a multi-column chromatography capture step, followed by flow-through virus inactivation, multi-column intermediate purification, a flow-through membrane adsorber polishing step, continuous virus filtration and a final ultrafiltration step operated in continuous mode. K.B. Konstantinov and C. Cooney have written an excellent review on this subject.

Continue reading “Continuous or intensified bioprocessing? The gold standard for improved productivity”

New analysis methods are needed for sub-visible particles in drug development

At Vironova we’re in the business of electron microscopy-based digital image analysis of sub-visible particles to provide objective and meaningful information during process development and quality control of vaccines and drug/gene delivery systems.

In current advances in drug-delivery, production of vaccines and drug formulation there are many applications for nano-sized particles such as liposomes and virus particles, and these constitute fast growing and promising technologies for new treatment development.

Continue reading “New analysis methods are needed for sub-visible particles in drug development”

Extractables and Leachables: Standardizing Approaches to Manage the Risk [eBook]

15-3-March-eBookThe implementation, maturation, and benefits of single-use technologies in biopharmaceutical development and manufacturing are well documented and understood. As analytical methods and testing services also rapidly improve, it is clear that management of risk associated with extractables and leachables also must evolve. Standardization is universally accepted as a goal; how to define, implement, and educate the industry is where debate resides.

The container–closure segment has had more experience dealing with leachables and extractables than those implementing single-use process components do — they’ve just been doing it longer. BPI takes a closer look at relevant guidance and regulations and examines how groups such as BPSA, ELSIE, ISO, and USP are helping users make sense of it all.

This eBook reviews the industry’s approach to leachables and extractables to address an underlying question: How close are we to making standardization a reality?

Read an excerpt from the eBook below:

Continue reading “Extractables and Leachables: Standardizing Approaches to Manage the Risk [eBook]”

Round-up: Cell Therapy Manufacturing & Gene Therapy Digital Week

Last week we hosted the inaugural Cell Therapy Manufacturing & Gene Therapy Digital Week. An agenda of seven live webinars covered a range of the hottest topics in the industry, led by leading life science thought leaders from GSK, ISCT, Cell Medica and many more.

Every session is now available to watch on-demand at the links below. If you registered for the live event you can watch the on-demand sessions with the same login details, or if you haven’t yet registered it only takes 10 seconds.  Continue reading “Round-up: Cell Therapy Manufacturing & Gene Therapy Digital Week”

Understanding nanoparticle based processes and products

Josefina Nilsson, Head of EM services at  Vironova, is speaking on the characterization of gene therapy vectors, VLPs and whole viruses at BioProcess International Europe 2017. We asked her about nanoparticle based processes and products.

Why are modern techniques needed for a better understanding of nanoparticles in process development and production?

‘There is a need to link product understanding and process control during biopharmaceutical development. There are many parameters to track such as aggregation, changes in morphology and integrity as well as purity of particles/recombinant proteins/monoclonal antibodies. Sub-visible particle characterization is essential when comparing sample quality at different formulations or after various purification steps to achieve final product quality and stability.

We need methods that provide sufficient resolution and detailed information and that are cost-effective and adaptable to the regulatory requirements for routine drug development.

The combination of visual proof and metric values is not achievable from the currently used indirect methods like dynamic light scattering, nor is it feasible with conventional electron microscopy mainly due to the very long hours of manual work required.’

What are the challenges around regulatory expectations for nanoparticle based processes and products?

‘Methods and measurements need to be robust, reproducible, traceable and of course objective. Nanoparticles need to be visualized at high resolution to assess their purity and integrity, amongst other parameters.

The MiniTEM™ system from Vironova precisely provides the high-resolution visualization (through transmission electron microscopy) required. Automation enables accumulation of the large amount of data and analysis of the statistically relevant number of particles that are needed to produce objective measurements.

Having access to this bench-top, easy to use technology on-site and being able to routinely check samples at different phases during development omits the risk of moving too far down process design routes that will not result in desired final product quality.’

Josefina Nilsson is speaking on Day 1 of BioProcess International Europe 2017. Her talk – Characterization of Gene therapy vectors, VLPs and whole viruses from pre-formulation through process development to final manufacturing – is part of the Vaccine Manufacturing stream on 25th April in Amsterdam. To find out more and register for a pass to join 800+ bioprocessing decision makers at BPI Europe, visit the website