Affordable Breakthrough Therapies

An Interview with Denis Bedoret of MaSTherCell

We recently sat down with Denis Bedoret, Chief BD Officier at MaSTherCell in Amsterdam at the Cell Therapy Manufacturing & Gene Therapy Congress conference to discuss the critical issues and opportunities present in the cell & gene therapy industry today.

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Novel Strategies for Gene and Cell Therapies

By Manuel J. T. Carrondo, Prof. Chem & Biochem Eng., FCT/UNL & Vice-president, iBET

Since the early nineties iBET has been involved in production and purification of viruses for gene therapy. Early on, enveloped retroviruses and non-enveloped adenoviruses where the targets; from late nineties onward lentivirus and baculovirus were added to the portfolio of enveloped viruses and AAV to the non enveloped viruses.

Although originally meant for monogenetic diseases, now some are also produced for cancer treatment (ex. oncolytic adenoviruses made in A547 cells, so replicative) or as reagents for cell therapies (also known as ex-vivo gene therapies).

Having developed scaled down tests and analyticals (including surface plasmom resonance, dynamic light scattering) coupled with its chemical engineering model competencies, iBET has designed membrane or media materials for which our key partners MERCK Millipore, SARTORIUS, GE HealthCare have developed the prototypes tested on our biologies and equipments. In this way, improved DSP processes have been created increasing viral yields and infective to total particle ratios or yields and viability for cell therapies.

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The Recent Growth of Biotech Clusters Around the Globe

David Brindley, Senior Research Fellow at University of Oxford Department of Pediatrics comes from a very interesting background that covers both academia and industry. He joined us during Biotech Week Boston to discuss the relationship between academia and industry, what he identifies as the key regulatory challenges in both the US & Europe, and then finally he explores the recent growth of biotech clusters around the globe.

By design, there are a number of initiatives around that globe to create biotech clusters. “The two greatest biotech clusters in the world are undoubtedly the 128 corridor around Boston and Silicon Valley on the West Coast” Brindley says. However, he does mention that these clusters were development completely by accident, and not by design. Moving forward, as the growing of biotech cluster initiatives progress, these regional hubs need to focus/specialize on a very deep niche. If you are looking to set up a new cluster, Brindley says, “you should worry less about the platform technology it will develop,  is it monoclonal or is it small molecule. And [instead], focus more on ‘what is the bioprocessing problem that we are going to address here? Is this going to be a center of manufacturing?’ because I think even saying we are going to be a center of drug development is too broad.” This train of thought shows that collaboration is necessary for large-scale success of the industry.

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Cell Therapy Manufacturing and Gene Therapy Digital Week

27-30 March, 2017

KNect365 is pleased to introduce a special Digital Week program, comprised of a week-long series of free webinars with live Q&A – connecting cell and gene therapy leaders throughout the year from the comfort of your desk.

Cell Therapy Manufacturing & Gene Therapy Digital Week connects cell and gene therapy leaders to drive manufacturing and commercialisation through direct access to innovative discovery, product development, and regulatory know-how.

Register now to watch free educational sessions presented by leading industry experts, get answers to your toughest questions, network with colleagues and partners, and download useful resources.

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Direct Inoculum of Bioreactors with CHO Cells from Frozen Seed Bags to Eliminate Continual Seed Trains and Improve Facility Utilization

This article was originally published on www.CellCultureDish.com

By Brandy Sargent, Editor, Cell Culture Dish

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Flexibility in cell culture manufacturing via a reduction in process duration can be a key strategy for maximizing facility utilization and facilitating the production of multiple therapeutics from a facility. A key bottleneck is the seed train, which can add weeks to the timeline of the production culture. Seeding production bioreactors with a direct, cryopreserved CHO cell inoculum could possibly eliminate the need for a lengthy, continuous seed train and provide other numerous benefits.

At this year’s Boston Biotech Week, two feasibility studies were presented that showed the use of a Frozen Seed Bag (FSB) for direct cell inoculum into a production bioreactor. Shahid Rameez of KBI Biopharma and Nikhil Ramsubramaniam of Merck presented separate studies demonstrating the use of frozen inoculum in fed-batch production bioreactors (KBI) or perfusion bioreactors (Merck).

KBI described a current state-of-the-art production process consisting of scale up from spinner flasks, through a bag bioreactor into stirred tank bioreactors – a 5-week process (see Figure 1). According to the study results presented, implementation of a direct frozen inoculum approach could potentially reduce a 5-week timeline to as little as 1.5 – 2 weeks. Such an improvement could vastly increase the productivity of current cell culture manufacturing facilities.

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CDMOs & Cell Therapy Companies

A look at the evolution of regenerative medicine.

“The major gap between the cell therapy company and the CDMO is the experience in cell therapy manufacturing. The GMP environment for aseptic processing is very difficult/challenging and this is the expertise that resides with the CDMOs.”

In this interview, Ohad Karnieli, CEO of ATVIO Biotechnology and CTO/Co-Founder of Karnieli Ltd. explores the challenges that CDMOs (contract development and manufacturing organizations) need to address with Cell Therapy companies, what those challenges reveal about the evolution of the regenerative medicine industry, whether cell therapy start-ups should partner with CDMOs, and what the Israeli ecosystem means for ATVIO.

When discussing the collaborations between CDMOs and cell therapy companies, Dr. Karnieli mentions how there needs to be overlap between the different companies in order to bridge the gap and create better processes. To listen to all insights Ohad Karnieli presented us with, watch the full interview above.

 

Stability Studies vs. Protein Therapeutics

An interview with Christopher Bravery, Director of Consulting, Advanced Biologicals Ltd.

We recently sat down with Christopher Bravery, Director of Consulting at Advanced Biologicals Ltd. to discuss stability issues and how they differ between cell therapy development and antibody development, analytical methods for cell therapy development, and what is still needed in terms of stability.

There is a myriad of issues around cell therapy and you have two basic choices to make in early development; will I provide this as a fresh product or a cryopreserved product. There are pros and cons to both, so what does the future hold in terms of development in order to make a huge difference in commercialization?   Watch the interview below to hear what Christopher has to say on these topics and many more…