by Cheryl Scott, Senior Technical Editor, BioProcess International
Continuous processing is pretty much a “given” in many industries — even the larger pharmaceutical industry that makes synthetic small-molecule drugs. But the concept has only just begun to make inroads with biomanufacturers, who have until recently worked mainly in batch or fed-batch mode. Single-use technologies largely have enabled them to consider the possibility of process intensification and going continuous. In support of this month’s featured report, I asked contributor Margit Holzer, PhD (scientific director at Ulysse Consult S.a.r.L in Luxembourg) a few general questions on the topic.
One question often asked of perfusion and other continuous culture approaches is “How do you define a batch?” Some experts say it isn’t even necessary to do so. Others say you can describe batches in terms of time. What do you think?
HOLZER: It is important to recall that traceability of the whole batch history of a drug substance or product is absolutely necessary for CGMP production. So there is no choice. A batch also needs to be defined for continuous upstream operations. This becomes especially crucial during investigations or product recalls. In the case of continuous production, a batch may correspond to a defined fraction of production.
The batch size of a continuous upstream process can be defined, for example, by a fixed quantity (e.g., volume, mass, or activity units of product) of harvested product; the amount produced within a fixed time interval (e.g., hours of production, residence time) between harvests; or the number of cell generations or doubling times to be produced, collected, and further treated in downstream processing as one batch. In addition, a minimum titer and/or viability and/or other quality requirements can be specified as acceptance criteria for pooling with the harvested product to assure batch homogeneity. For all those cases, downstream processing capacity must be in line with the harvested quantity of material.
What’s the most challenging part(s) of downstream processing to do continuously? Continue reading “Continuous Processes: Disposables Integrate Upstream and Downstream Processing – Featured Report”
by Cheryl Scott, Senior Technical Editor, BioProcess International
At least one innovator company has embraced the concept of biosimilars wholeheartedly, calling it “our next chapter in healthcare” in a 2016 report. That publication cites product characterization, preclinical studies, nomenclature, reimbursement, and regulatory pathways as the primary challenges facing companies in biosimilar development. (Note: See Amgen’s 2017 biosimilars report here.) For our own featured report on biosimilars this month, we asked the contributors about those topics. The answers below come from Bruno Speder (head of clinical regulatory affairs at SGS) and Mario DiPaola (senior scientific director at Charles River Laboratories).
Product Characterization: What is the most challenging aspect of biosimilar characterization? How are companies obtaining originator samples to compare against?
SPEDER: One major challenge in developing biosimilars is to obtain sufficient originator product for characterization testing in both the preclinical and clinical development phases. The supply of originator product is very closely monitored by the manufacturers of those products because they seek to slow down the development of biosimilars. So this can be a difficult task. Originator product samples usually are obtained through specialized distributors.
Preclinical Studies: Can nonclinical/animal studies aid in supporting extrapolation of indications? Continue reading “Biosimilars: Technical and Regulatory Challenges Featured Report”
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”
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”
“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”
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.
“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”