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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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.

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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.

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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.

Building a Sustainable Academic Engine for Feeding Derisked Assets into the Biopharmaceutical Pipeline

Stanford is an engine for innovation” – David DiGiusto

Stanford has a vast pipeline of cell and gene therapy applications or products that are wishing to move their way to the market. David DiGiusto, Executive Director of Stem Cells & Cellular Therapeutic Operations at Stanford University, joined the Stanford team to develop the infrastructure to translate those cell and gene therapy products to the clinical initially, but ultimately to develop those products as the standard of care treatment for a variety of diseases, including; cancer, immune disorders, monogenic diseases and regenerative medicine.

The infrastructure built around manufacturing and clinical facilities has been quite impressive to date. Aside from that, Stanford has also been developing the staff and paradigm by which they select products to move towards the clinic, as well as the way in which they partner and reinvest any revenues from partnerships into the discovery engine to keep the cycle going.

Hear more of the exciting work being done at Stanford from David DiGiusto in this exclusive interview…  Continue reading “Building a Sustainable Academic Engine for Feeding Derisked Assets into the Biopharmaceutical Pipeline”

Monoclonal Antibody Platform Processes

By Nick Hutchinson

Therapeutic monoclonal antibodies (mAbs) have had a significant impact on both medicine and the biopharmaceutical industry. Oftentimes different mAb products will have similar properties to one another. In turn, this means companies can use similar production methods to produce multiple mAb treatments from their product portfolio or pipeline. I spoke to Dr Piranavan Thillaivinayagalingam, Director of Project Management from Alvotech Germany to learn more about the industry’s current approach to manufacturing mAbs with platform processes.

What does the phrase ‘platform process’ mean to you?

Platform processing, to me, means having a standardized approach to a range of activities required to develop and operate a biologics manufacturing process. These activities range from cell line development through to steps for the formulation of drug substance. Standardized activities allow drug developers to perform these steps in the fastest and most cost-effective way. In my role, platform processes are particularly important in getting products through to clinical phase I and II manufacturing as quickly as possible.

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How to Master Data Management during Bioproduction?

With the advancements in technology we are able to make better and wiser decisions that can impact the way we develop products nowadays however with better analytics comes more data and the question now is how to manage this. We asked Jarrod Medeiros, Product Specialists at the leading data management company IDBS about their thoughts on the subject and what advice they could share.

Jarrod

Informa: you recently published a white paper on the subject. Why was that?

IDBS: Because we wanted to educate the community on some of the problems we’ve solved for similar customers.

Informa: How can ineffective data management impact the development of biologics?

IDBS: There are a few effects. A major one is efficiency, we’ve found through working with various customers that a large portion of scientists’ time is spent looking for data, transcribing data, and other low value activities associated with paper notebooks, binders, and MS Excel. Another big effect we’ve seen is on quality. This includes the quality of the data itself which can be compromised due to hand writing and transcribing between systems. But also the quality of the output, when data is ineffectively managed the reports and analyses that can be done are limited.

Informa: What advice would you give to industry to handle the vast volumes of data produced in biological development?

IDBS: Use E-WorkBook?! Come talk to us!? I suppose the first step is to admit it is a problem, and then work with vendors that have expertise in solving these challenges.

Informa: How should data management systems be applied to improve decision making in the development and manufacturing of biological products?

IDBS: One of the largest impacts on decision making comes from the ad-hoc analyses that can be done. It’s easy to prepare data and visualizations that need to be used regularly, but when something unexpected happens it is time consuming and sometimes impossible to pull data together in an ad-hoc manner. Data management systems should capture the relationships and context required to be able to quickly view traceability and make decisions.

Informa: What do you see as the best strategies for gaining insight from the increasing amount of data generated and translating this data into knowledge outcomes for products and processes?

IDBS: The best strategy is to move away from a paper and MS Excel-based process as soon as possible. The longer you wait to implement an electronic system for data management, the more of your historical data continues to be in an unusable state.

Join us at BioProduction 2015 to hear more from Jarrod Medeiros, where he will be presenting on leveraging laboratory informatics for the bioprocessing industry on 15th October at 12:05.