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.

Continue reading “Affordable Breakthrough Therapies”

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.

Continue reading “The Recent Growth of Biotech Clusters Around the Globe”

How to Overcome the Funding Gap for Biotech Start-Ups

At Biotech Week Boston, we sat down with Tyler Merkeley, Health Scientist, Head of Special Projects & Portfolio Management at BARDA for an exclusive interview. He was also a panelist on the discussion on “How to Overcome the Funding Gap for Biotech Start-ups and Emerging Companies“.

The Biomedical Advanced Research and Development Authority (BARDA) is a U.S. Department of Health and Human Services office responsible for procurement and development of countermeasures principally against bioterrorism, but also including chemical, nuclear and radiological threats. Naturally, they are responsible for a national preparedness for pandemic and emerging threats.

Continue reading “How to Overcome the Funding Gap for Biotech Start-Ups”

What Components are Introducing Risk in Aging Facilities?

At Biotech Week Boston, we sat down with Dr. Christopher Smalley, Senior Consultant at ValSource (formerly the Director of Global Technical Operations at Merck & Co.) for some exclusive insights into evaluating risk of components in aging facilities.

As the biopharmaceutical pipeline is becoming more complex, the industry is rethinking the traditional one product-one facility approach to manufacturing. This attempt to create flexible manufacturing facilities not only addresses the need for multiple products but also can accommodate market demand.

In this exclusive interview, Dr. Smalley addresses some of the major challenges and trends in the bioprocessing industry today;

Continue reading “What Components are Introducing Risk in Aging Facilities?”

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.


Innovative Methods for Quantitating Host Residual DNA in Biologic Drugs

“Every lab that does host residual DNA from biologics should use the direct method, it will reduce work time and increase accuracy.”

Musaddeq Hussain Ph.D., Principal Scientist of Bioprocess Development at Merck Research Laboratories joined us at Biotech Week Boston to discuss innovation in quantifying host cell DNA for biologics. In this interview, he delves into the new state of the art methods of quantifying host cell DNA for biologics, which of those methods are especially useful improvements, the types of products that require customization, where new/more sensitive technologies are needed, and the existing solutions that companies don’t know they can take advantage of. To hear Dr. Hussain’s exclusive insights on these key industry trends, access the complete interview now.

Continue reading “Innovative Methods for Quantitating Host Residual DNA in Biologic Drugs”

Exclusive Insights into BPOG

An interview with Lars Hovmand-Lyster of Novo Nordisk

Lars Hovmand-Lyster, Senior Engineering Specialist at Novo Nordisk sat down with the KNect365 team to discuss what led to his participation in BPOG, the issues that arise when discussing private matters between the various companies, the willingness companies have to share experiences & best practices, and the advantages that being part of such a group has for Novo Nordisk.

In this interview, Lars discusses how working with BPOG is a way to harmonize and discuss issues about [in his worksteam] room classification and viral segregation. He continues on to mention that BPOG both challenges his own thoughts about how Novo Nordisk does things, but it also helps to hear what others companies are doing [in a more informal way]. The group provides members the possibility to discuss major industry issues without compromising their confidential processes.