The unique Leadership Roundtable will explore diversity, opportunity for mentorship and career development with top leaders in the bioprocess industry.
View the full press release: 3M Biotech Forum Luncheon News Release
3M Separation and Purification Sciences Division (SPSD) with Biotech Week Boston are initiating a new event: the 3M Women in Bioprocess Roundtable Forum and Lunch, an opportunity for women scientists to share their work experiences with executive leadership in the bioprocessing industry.
Participants will network with pioneering leaders in the field, learn about bioprocess career trajectories, and create personal connections with women scientists and executives in a variety of companies.
The event will be held on September 27th where panelists will answer moderated questions from audience members registered for the event on the topic of pivotal career experiences and other key learnings for women in the industry.
Continue reading “Connecting Women in Bioprocessing with 3M at Biotech Week Boston”
Poliovirus and one of the Science Heroes that made this Headline Possible: Eckard Wimmer, Ph.D.
Polio has been around for centuries – but it’s almost gone – thanks to the efforts of many scientists, such as Drs. Jonas Salk and Albert Sabin, as well as Eckard Wimmer, Ph.D., a National Academy of Sciences Scholar. Polio was first described clinically back in 1789 but it wasn’t until nearly a century later in 1894 that the first polio epidemic occurred. Polio peaked in 1952 when 3,145 people died and thousands more were paralyzed. Around this time, the first vaccines were introduced which had a profound impact reducing the incidence of this disease and inspired one scientist in particular who went on to achieve breakthroughs in poliovirus after fleeing Berlin at the height of WWII, then later fleeing East Germany to continue his studies.
Dr. Wimmer, then a chemist, became fascinated by poliovirus as the first example of a self-replicating chemical and pathogenic entity, “a chemical with a life cycle”, and dug in to research its biology. He and his lab were the first to sequence a eukaryotic RNA virus. They also elucidated its unique structure (the first RNA virus to be linked to a protein later discovered to be involved in RNA replication) as well as to decipher the genetic organization of the poliovirus genome. These groundbreaking efforts enabled Dr. Wimmer to chemically synthesize the poliovirus genome – essentially becoming the first to successfully synthesize a living organism outside a cell. In short, the world’s first test-tube virus was “born”, and, along with it, the dawning of the age of synthetic biology.
Continue reading “16 Million People (and counting) Saved From Paralysis”
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 Nick Hutchinson
Once upon a time, this seemed like a very easy question to answer. Engineering companies designed facilities with stainless steel equipment to the user requirement specifications of their biomanufacturing customers. These biotech companies then operated the facilities, producing quantities of product to supply the market. They understood these products, having developed them in-house, and had designed, characterized and scaled-up the required bioprocess. They put in place the quality systems necessary to ensure the safety of their patients. In short, these biopharma companies were vertically integrated with competencies in developing, producing and marketing their products in a tightly regulated market. To better serve their customers they invested in manufacturing sciences leading to process innovations that lowered costs, increased throughput and improved product quality.
Leading biopharmaceutical firms still see biomanufacturing as a core competence. Amgen, to give one example, proudly states in its 2016 Annual Report that the company’s “long record of delivering reliable supplies of high-quality medicines with improving efficiency is a source of differentiated competitive advantage”.
Continue reading “Who are the competent biomanufacturers?”
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”
‘If one or two CAR-T therapies get to market it will provide impetus and momentum behind the industry’ – Dr Akshay Peer, Vice President of Sales and Account Management at TrakCel discusses the revolutionary steps that cell and gene therapies are making through their increased commercialisation.
In a field that is constantly seeing developments, Dr Peer outlines CRISPR and CAR-T therapies as forms of gene editing that can dramatically change the face of gene therapies and their use within modern medicine. He believes that as the commercialisation of these treatments increases, the regularity of their use will as well.
This is due to the surge in ‘positive public opinion’ that will arise from the successful implementation of the therapies. Dr Peer identifies the positivity that already exists around the new therapies, with ‘everyone looking at when these therapies will come to market and how much they will cost’. Although not going into detail about the financial outcome, he outlines his hope that when the public can see the lives of adults and children enhanced by using these therapies, any uncertain opinions will change to ones of optimism and confidence.
Peer acknowledges the lack of information that can exist around the new therapies due to an unfamiliarity in their usage; ‘People can sometimes get ahead of themselves and not understand completely what we’re trying to do here in this industry’. However, he is sure that this will change once there is evidence of patients who are successfully treated.
There is clearly excitement developing around the use of gene therapies, outlined by Dr Peer.
Watch the full interview, filmed at Cell Therapy Manufacturing & Gene Therapy Congress, with Dr Peer above or here.
The 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]”