This week’s headlines include: The Senate Just Confirmed Scott Gottlieb to Lead the FDA, GSK’s inhaler improves asthma control in ‘real world’ study, Gates Foundation Supports Achaogen’s Antibacterial Platform with $20.5M, Novartis, Roche back French Gene Therapy start-up Vivet, Drug Prices Are Growing At The Slowest Rate In Years. Here’s Why It Doesn’t Feel That Way, and JSR Life Sciences Expands Amsphere™ A3 Production Capacity.
In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:
There are an increasing number of T cell-based therapeutics moving through clinical trials. These immunotherapies hold tremendous promise and much of the clinical trial data has been impressive. As these therapies have progressed toward larger trials and commercialization, focus is shifting from proof of concept to consistent and sustainable manufacturing…
It’s not surprising that many scientists are creatures of habit. After all, the “re” in “research” often feels like it stands for “repeatedly”. This attitude means that more often than not, scientists will develop a preferred “go-to” protocol. These are the ones that have been run countless times over the years, and become the protocol to learn for anyone new to the group…
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…
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.
Manufacturing biologicals is tricky. A major concern is the risk of microbial contamination, jeopardizing product safety and causing high costs. But there are solutions for decreasing the risks. Making monoclonal antibody (mAb) drugs? Safety first. In releasing a biomedicine, the last thing a biopharma company wants is for people to be harmed. This makes the risk of bioburden, and how it can be prevented, a major issue for drug safety…
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…
May 16, 2017- 10:00 AM EST
New vaccine process designs – and all the kinks that go with them – are typically hammered out in a small scale capacity, for example, prior to manufacturing for early phase human clinical trials. They are then upsized and further defined for industrial scale to supply the vast market. Single-use technologies (SUTs) have been a hot topic for several years now and their advantages well-known: easy product changeover, processing in lower classification areas, reduced CAPEX, elimination of glass, sterility assurance, to name a few. In vaccine manufacturing, SUTs are used throughout the processing stages, from cell culture all the way to filling. SUTs are quickly and conveniently designed, purchased and implemented for short-term manufacturing of clinical trial phase materials. Here a large percentage of new vaccines in Research and Development do not even make it to market.
As the final production stages are critical as they are the last stages before patient injection, the scope of thisarticle covers SU applications involving drug substance formulations, adjuvant processing, final bulk formulation and filling. The actual process itself may include some or all of the following: filtration, pumping, ingredient addition, mixing, adsorption, filling, labelling, sampling and and storage.
In this presentation only liquid formulations (“presentations”) will be discussed.
Presented by Kirsten Strahlendorf of Sanofi Pasteur
May 18, 2017 – 9:00 AM EST
Continuous bioprocessing for biologics manufacturing is being adopted in the biopharmaceutical industry by big players such as Merck. Pall Life Sciences has partnered with Merck to help bring this innovative technology platform to fruition.
In this webinar, Pall’s development journey in continuous bioprocessing will be described along with highlights of recent technology advances
Merck will present the development of a continuous Protein A chromatography process step using KANEKA KanCapA™ for the capture of a therapeutic mAb. The method was developed initially in a batch mode and then transferred to the Cadence BioSMB PD system. This five column process was then successfully scaled-up 150-fold using the Cadence BioSMB Process system. The entire process development and scale-up was completed within four weeks and described in detail along with the process economic benefits of using multi-column chromatography.
Participants will learn:
- How to reduce facility footprint, capital expenses, and product cost of goods
- How to improve your process productivity, flexibility, and further facilitate the utilization of single-use and/or disposable technologies
Dr Peter Levison, Senior Marketing Director- Downstream Processing, Pall Life Sciences
Dr Mark Brower, Principal Scientist, Merck
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.
“The U.S. Senate voted on Tuesday to confirm Dr. Scott Gottlieb, a health policy expert and venture capitalist, as commissioner of the Food and Drug Administration, which regulates everything from food and drugs to tobacco, cosmetics and dietary supplements…”
“GlaxoSmithKline and Innoviva have unveiled data from a second ground-breaking Salford Lung Study (SLS) showing that Relvar Ellipta significantly improved asthma control versus patients’ standard therapy. Patients initiated with Relvar Ellipta (fluticasone furoate/FF and vilanterol/VI) had twice the odds of achieving an improvement in asthma control than those continuing with their usual care, which included inhaled corticosteroids (ICS) administered as monotherapy or as ICS/LABA (long acting beta agonist) combinations…”
“The Bill and Melinda Gates Foundation has awarded Achaogen $10.5 million in grant funding and is making a $10 million investment in the South San Francisco-based firm to support the identification of monoclonal antibodies (mAbs) against serious, multidrug-resistant (MDR) Gram-negative bacteria. The initial grant will fund Achaogen’s program to discover mAbs against Acinetobacter baumannii, which is the major cause of neonatal sepsis. If this project is successful, Achaogen may receive future grants from the Gates Foundation for additional antibody discovery and development programs…”
“Its lead program VTX801, which is expected to enter clinical testing by the end of 2018, targets a condition called Wilson disease caused by a defective gene in liver cells that can require liver transplantation and is sometimes fatal…”
“You’d think, from the political clamor, that the cost of prescription drugs is rising out of control. But actually, growth in drug prices this year was half of last year, according to a new report from The QuintilesIMS Institute, an arm of a gigantic pharmaceutical industry consulting firm. More than that, the average out-of-pocket cost to consumers has decreased…”
“JSR Life Sciences Expands Amsphere™ A3 Production Capacity,” Business Wire
“JSR Life Sciences (JLS), the global life sciences focused division of JSR Corporation, today announced plans for expansion of its production capabilities of AmsphereTM A3 protein-A chromatography resin at JSR’s Belgium subsidiary, JSR Micro NV. This expansion will effectively increase the company’s production capacity by 6 times and provide all-important redundancy in its manufacturing capability…”