The Dish’s Weekly Biotechnology News Wrap Up – May 12, 2017
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:
Cool Tool – Optimizing T cell media with animal component free, recombinant human serum albumin
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…Out with the old, in with the new: cleaning-up your methods
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…Ask the Expert – 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…Purposeful design of a next-generation single-use film for optimized performance in biomanufacturing
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.
Cost and impact of a bioburden incident
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…Antibody Fragment Purification Platform
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…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…
Webinars:
Developing Practical Single-Use Processes for New Vaccine Formulations
May 16, 2017- 10:00 AM EST
SUMMARY 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 Webinar – Scale-up of Continuous Chromatography using Cadence™ BioSMB Process System 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