This week’s headlines include: The top 10 pharma R&D budgets in 2016, European Regulatory Roundup: EMA and FDA Discuss Joint Accelerated Assessments, FDA approves Samsung Bioepis’ copy of J&J’s Remicade: company, H3, Foundation Medicine Extend Precision Oncology Collaboration, Two-horse race: Auris, Otonomy seek FDA nod for inner-ear therapies, and Florida releases experimental mosquitoes to fight Zika.
In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:
World’s Largest hiPSC Bank: Made in California
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 Overview and How to Control Glycosylation using In Vitro Glycoengineering
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….
A Novel Approach for Expansion of High Quality Mesenchymal Stem Cells
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…
Cell Therapy Clinical Trials: Navigating the operational shift from Phase 1 to Phase 2
When navigating through the various phases of a Cell Therapy
clinical trial, it’s important that each phase “sets the stage” for those which follow. All activities that take place in Phase 1 will ultimately impact Phase 2, and so on through to commercialization. This blog will focus on the operational shift from Phase 1 to Phase 2 and the associated challenges with doing so…
Addressing Buffer Bottlenecks using automated In-line conditioning and ready-made stock solutions for mAb processes
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…
FDA CDER Novel Biologic Drug Approvals 2016
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…
Job Outlook for the Biomanufacturing Industry
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…
Cool Tool – Scale up with confidence – Introducing ReadyToProcess™ 32 L (450/200)
To reduce costs, increase flexibility and shorten time to market, the use of single use and disposable technologies have increased significantly in biopharmaceutical development and manufacturing. In downstream processing prepacked chromatography columns reduce the need for time consuming cleaning validation and column packing. The last few years has seen a steadily increasing implementation of prepacked chromatography columns in process development and clinical manufacturing. Many of these projects are now scaling up for commercial production…
Thursday, May 4, 2017, 11:00 AM ET
Speaker: Lia Thornberry Kent, Biological Industries USA
Maintaining healthy human pluripotent stem cells (hPSC) is sometimes more of an art than a science. Many culture techniques follow simple protocols, but require a great amount of interpretation to perform. In addition, the exact protocol will vary each time, depending on the ever-changing state and needs of the cells. In order to keep your hPSC cultures healthy, you must determine the best time to passage, what split ratio to use, and how to clean up areas of differentiation. This webinar will cover the basic rules for maintaining excellent cultures, and tips to improve passaging, freezing, and thawing techniques.
- hPSC morphology and colony growth characteristics
- How to determine the best time to passage
- Enzymatic and manual passaging techniques
- Tips for successful hPSC cryopreservation and thawing
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
Cell Culture & Cell Therapy: Bioprocessing Conference – June 26-27, 2017, Philadelphia
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.
“Last year, biopharma won its share of new drug approvals, though not as many as we’re used to in the U.S., as research spending came to fruition. But drugmakers also suffered a number of R&D setbacks, cut research staff, rejigged their operations and refocused their pipelines…”
“The European Medicines Agency (EMA) has revealed it is talking to its counterpart in the US about joint activities covering accelerated assessments. The subject is one of several areas in which EMA and the US Food and Drug Administration (FDA) are considering stepping up their cooperation…”
“South Korea’s Samsung Bioepis Co Ltd said on Saturday the U.S. Food and Drug Administration approved its copy of Johnson & Johnson’s rheumatoid arthritis drug Remicade, the first drug developed by the Samsung Group unit approved in the United States…”
“Eisai subsidiary H3 Biomedicine said today it has extended its more than 2-year-old collaboration with Foundation Medicine to discover and develop precision medicines in oncology. The value of the expanded collaboration was not disclosed…”
“Doctors have struggled for years to deliver medication effectively to the inner ear, but two companies are vying to be first to introduce new treatments which, if successful, could together chalk up some $800 million in peak sales…”
“Thousands of mosquitoes infected with the Wolbachia bacteria were released in an area of the Florida Keys this week, in hopes of a new approach to control the disease-carrying female Aedes aegypti mosquito, which transmits Zika virus, Dengue fever and Chikungunya…”