This week’s headlines include: Here’s the visual proof of why vaccines do more good than harm, Dr. Julius Youngner, Polio Vaccine Pioneer, Dies at 96, B is for biotech: Alphabet, and its search for life science glory, Charter Medical Announces Exclusive Global Distribution Agreement with INCELL Corporation, MockV Solutions Announces Collaboration with Texcell N.A. to Assess MVP Technology, and U.S. FDA approves Novartis’ leukemia treatment.
In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:
In this mini-webinar, Susan Burke, PhD, Bioprocess R&D, GE Healthcare, Life Sciences, presents the process in which GE Healthcare developed a next-generation single-use platform film, Fortem™. Fortem is available across GE’s entire portfolio of single-use products and was designed to maintain critical performance attributes, such as container integrity and gas barrier properties, under the significant forces exerted during bioprocess operations.
The value and need to establish stem cell banks of validated and quality-controlled human pluripotent stem cell (hPSC) lines has long been recognized by researchers to ensure that work from different laboratories worldwide could be replicated and compared. These cells are used for research applications such as developmental biology, toxicology and drug discovery and to study their potential in Cell Therapy. These investigations are being performed with many pluripotent stem cell lines grown in a variety of culture conditions making standardization difficult and could generate cells that have acquired permanent deleterious changes. The consequence of erroneously using such cells is not only wasted time and resources but, more importantly, the generation of incorrect data that, if published, could both confuse and delay scientific progress (Stacey et al, 2013). Therefore, ensuring that cell lines used in the pluripotent stem cell field are properly validated and characterized is vital to achieving high quality research…
Glycosylation is the most common type of post translational protein modification. It is also an important factor in manufacturing therapeutic proteins, depending on the mode of action, because it can impact protein stability, biological activity, and the pharmacokinetics of the final product. Due to the impact that glycosylation can have on the therapeutic, it is frequently identified as a critical quality attribute. Thus, it is important to control glycosylation during manufacturing to ensure consistent glycosylation for the final product….
Human mesenchymal stem cells (hMSCs) are a promising tool for therapeutic applications in cell-based therapy and regenerative medicine. Increasing evidence has shown that MSCs represent new hope for treating, and in some cases, perhaps even curing human diseases like diabetes, Alzheimer’s, Parkinson’s, Muscular Dystrophy , inflammatory disorders, osteoarthritis and damaged cartilage, to name a few. And although stem cells have emerged as the future of health care there are still a number of unmet needs, which must be addressed before widespread clinical and therapeutic applications become a reality. One of the major challenges in Cell Therapy is obtaining sufficient numbers of quality stem cells while maintaining their differentiation potential. BM-HPME® (Bone Marrow – High Performance Micro Environment) overcomes key obstacles to capturing and growing stem cells without losing potency…
Since the 1980’s monoclonal antibodies have revolutionized medicine and become a vital tool in fighting many diseases. While there are many new monoclonal antibodies in the clinical trial pipeline, there are also some innovative drugs made from just an antibody fragment. Due to the multi-domain structure of antibodies, it is possible to create smaller antibody fragments that still include the antigen-binding domain. Antibody fragments have some advantages over full-length antibodies and several antibody fragment-based biotherapeutics are in clinical research. Several antibody fragments have been approved and are commercially available, including: ReoPro®, Lucentis®, and Cimzia®.
Multiple buffers in a wide range of formulations are required to produce a single biopharmaceutical. Because of the large volumes required, buffer preparation can easily become a bottleneck in production. Traditionally, buffers are prepared manually in the volume needed according to specific recipes. Due to the large quantities used, buffer management requires careful planning and considerable floor space is required for the preparation and storage of such large buffer quantities. In addition to high labor and facility space cost, there is a risk of human error and variability associated with such a time-intensive manual activity. Buffer variability can affect both quantity and quality of the final product…
The FDA just released its report titled “Novel New Drugs 2016 Summary,” in which they discuss 2016 FDA new drug approvals. In 2016, the FDA’s Center for Drug Evaluation and Research (CDER) approved 22 novel new medicines. The number of approvals in 2016 was down from 2015 with 45 approvals and down from 2014 with 41 approvals. In fact, in looking at approvals over the past five years, 2016 had the lowest number of approvals overall, however the number of new drug filings remained consistent…
In this podcast, we interviewed Hillary Kaplan, Director, Bioprocess CMC Development & Operations, Klein Hersh about the job outlook for the biomanufacturing industry from a recruiter’s perspective…
Ask the Expert:
Monday, May 8, 2017
GMP Proteins for Cell Therapy Manufacturing
GMP (Good Manufacturing Practice) growth factors and cytokines designed for therapeutic manufacturing are a critical component in defined medias. To date, the Cell Therapy industry has accepted the term GMP for this reagent class despite the fact that there is no direct oversight by regulatory authorities. These proteins are intended to be used during further manufacturing and do not come in direct contact with the patient. In fact, Cell Therapy manufacturers need to take steps to ensure that reagents used for further manufacturing are removed before the cells can be used in the clinic. In addition, FDA-regulated, clinical grade proteins that can be directly used as therapeutics may also be described as GMP, leading to confusion of the term “GMP” within different contexts.
We recently published a blog, “GMP Proteins for Cell Therapy Manufacturing: Top 6 Things to Know,” that discusses what you should look for in a supplier. It was a popular piece with readers, so we asked the author, Tim Manning, if he would host an Ask the Expert session on the topic. Tim was kind enough to agree to answer questions from readers this week on the topic of GMP protein manufacturing..
This should be of interest to anyone interested in Cell Therapy research or those manufacturing cells that will be used as therapeutics.
Cell Culture Events:
Cell Culture World Congress USA 2017 – May 24, 2017, Hilton San Diego Resort and Spa, San Diego, CA
The vision of Cell Culture World USA is to provide new, relevant content on process development for cell culture specific scientists working in bio manufacturing companies developing antibodies and immunotherapies. Over 4 years, the Congress has become a technical and networking forum for bioprocessing professionals to provide cutting-edge commentary, present novel and never-before-seen case studies, and highlight technological advancements to the industry.
Our 2017 event will feature a more focused structure, zeroing in on the topics that interest cell-culture specific scientists the most. Immunotherapies are the talk of the industry, and they’ll be a huge topic for this year’s event as well.
Download Brochure: https://goo.gl/t5ZRvx
Register now: https://goo.gl/KTOdxq
MarketsandMarkets put together a unique platform to establish the reproducible and robust manufacturing processes for the production of stable cell culture and therapeutic cells. At the Cell Culture & Cell Therapy: Bioprocessing Conference scheduled to be held in Philadelphia, USA on 26 – 27 June 2017, leading experts in the industry will be gathered to discuss strategies, technologies and innovations in the area of bioprocessing of cell culture and cell-gene therapies.
“Vaccines have beat back infectious diseases. Bubbles represent reported U.S. cases, but not all diseases were notifiable in all years. For example, mumps was not reported until 1968, the year after a vaccine was licensed…”
“Dr. Julius Youngner, an inventive virologist whose nearly fatal childhood illness destined him to become a medical researcher and a core member of the team that developed the Salk polio vaccine in 1955, died on April 27 at his home in Pittsburgh. He was 96…”
“While you’re searching for, statistically speaking, cat videos, Alphabet’s venture arm GV is searching for life sciences companies that are working on new ways to help people live longer. The California-based GV, formerly Google Ventures, which was launched in 2009 and has around $2.4 billion under management, started off with a Silicon Valley approach, but is now increasingly looking to add bio to tech…”
“Charter Medical Announces Exclusive Global Distribution Agreement with INCELL Corporation,” Digital Journal
“MockV Solutions, Inc. (MockV or the Company), a biotechnology company developing non-infectious viral clearance prediction products that address the unmet needs of process development scientists as they establish biopharmaceutical manufacturing platforms, announced today that it is partnering with Texcell North America, Inc. (Texcell N.A.) to assess its Mock Virus Particle (MVP) technology…”
“The U.S. Food and Drug Administration approved Novartis AG’s Rydapt as an initial treatment for acute myeloid leukemia (AML) as well as certain other blood disorders, the agency said on Friday. AML is a cancer that originates in the bone marrow and progresses rapidly, resulting in an abnormal increase in white blood cells…”