The Dish’s Weekly Biotechnology News Wrap Up – April 21, 2017

By on April 21, 2017

This week’s headlines include: In a Dragon’s Blood, Scientists Discover a Potential Antibiotic, Novartis advances with push on cancer and liver disease, Lion Biotechnologies, MD Anderson Plan Clinical Trials of TIL Cancer Therapy, Novartis drug development chief outlines CAR-T research commitment, BIO, AdvaMed Seek to Tweak FDA’s New Pre-Request Draft Guidance for Combo Products, and Enzyvant receives FDA breakthrough therapy designation for investigational therapy rvt-802.

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In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:

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Glycosylation Overview and How to Control Glycosylation using In Vitro GlycoengineeringGlycosylation 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…

GMP Proteins for Cell Therapy Manufacturing: Top 6 Things to Know

Using cells as a therapeutic offers one of the most promising new approaches for treating human disease. These methods include stem cell therapies and regenerative medicine, as well as immune cell therapies for cancers and immune-related disorders. Despite the promise, it has been difficult to bring these therapies mainstream. They are vastly more complex than traditional small molecule treatments or biotherapeutics. For example, in autologous therapies like CAR T, cells are removed from the patient, enriched for the cell of interest, genetically engineered to target the tumor, expanded in cell culture, and re-introduced into the patient as the therapeutic (Figure 1). Many of these steps have yet to be standardized and, along with the inherent variability in biological systems, there is increased potential for unanticipated results and risk to patients…


The Down Stream Column

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…

Fortem: A platform film built for bioprocess

The increase in adoption of single-use bags for manufacturing biopharmaceuticals has been driven by the many advantages it offers. However, the materials of construction can be more complex than conventional stainless steel vessels. Single-use containers are constructed from plastic films, which are often composed of several layers of polymers with additives for processing and performance…

Webinars:

Design, Characterization, and Scale-Up Strategy for a New Single-Use Production-Scale Bioreactor – April 27th 11:00 EST

The design of the initial range of single-use stirred bioreactors was cylindrical, essentially copying that of traditional stainless steel bioreactors. The cylindrical shape with dished ends was intended to minimize the expensive steel stainless wall thickness and still be strong enough to withstand the internal pressure developed during steam sterilization. However, since single-use biocontainers can be supplied presterilized, novel shapes can now be considered. Indeed a square cross-section design demonstrates some significant advantages over a cylindrical one.

This GEN webinar will first introduce and discuss the engineering concepts of the Allegro™ STR bioreactors, a square bioreactor design with volumes of 200 L, 1000 L, and 2000 L, and then utilize these concepts to demonstrate scale-up from the bench with a live culture.

Who Should Attend

  • Upstream bioprocessing engineers
  • Upstream process development scientists
  • Clinical and commercial manufacturing supervisors and technicians
  • QA/QC scientists

You Will Learn

  • Why a square cross-section brings significant advantages to the upstream process, for handling, process assurance, while maintaining optimal cell culture performance
  • About the performance of a square-shaped bioreactor, in terms of mixing efficiency, mass transfer of oxygen (kLa), and CO2 stripping
  • Applying system engineering principles toward bioreactor characterization, and how tech transfer methods are leveraged across designs, from the bench to production vessels

Cell Culture Events:

World Vaccine Congress – April 10-12, 2017, Washington D.C.

The 17th Annual World Vaccine Congress is the place where the global vaccine industry meets to discuss commercial and scientific issues around regulation, strategy, manufacturing, trials, partnering, influenza, cancer, emerging diseases and veterinary vaccines.

Across 150 sessions, you will learn from leading experts across the issues most impacting on the wider vaccine sector, as well as delve into your specialist area of research and job focus in co-located conferences.

Meet over 700 of your peers in one room and take advantage of the multiple extended networking breaks, co-located World Vaccine Congress (including 7 streams on Immune Profiling, Cancer & Immunotherapy, Influenza & Respiratory, Clinical Trials, Emerging Diseases, Partnerships, Veterinary Vaccines and Bioprocessing & Manufacturing) as well as the evening drinks reception.

For more information, please visit the website https://goo.gl/nJ2bZ1

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.

Headlines:

“In a Dragon’s Blood, Scientists Discover a Potential Antibiotic,” The New York Times

“Biochemists may have discovered a type of antibiotic that sounds like something out of a fairy tale: It is based on dragon blood. Scientists from George Mason University recently isolated a substance in the blood of a Komodo dragon that appeared to have powerful germ-killing abilities. Inspired by the discovery, they created a similar chemical in the lab and dubbed it DRGN-1.”

“Novartis advances with push on cancer and liver disease,” Reuters

“Novartis’s push into oncology and liver disease, two of its treatment priorities, advanced on Monday as the Swiss drugmaker won a second U.S. breakthrough tag for its cancer gene therapy while striking a separate pact with Allergan.”

“Lion Biotechnologies, MD Anderson Plan Clinical Trials of TIL Cancer Therapy,” Genetic Engineering News

“Lion Biotechnologies will partner with The University of Texas MD Anderson Cancer Center to carry out multiarm clinical trials assessing the company’s tumor-infiltrating lymphocyte (TIL) therapy in ovarian cancer, various sarcomas, and pancreatic cancer, through a collaboration whose value was not disclosed.”

“Novartis drug development chief outlines CAR-T research commitment,” Fierce Biotech

“Despite reports that linked Novartis to cutting back on its cell therapy work, the Swiss major said it is going full steam ahead for its CAR-T research as a potential approval for its candidate appears on the horizon.”

“BIO, AdvaMed Seek to Tweak FDA’s New Pre-Request Draft Guidance for Combo Products,” Regulatory Focus

“Industry groups BIO and AdvaMed are seeking some changes to the US Food and Drug Administration’s (FDA) guidance on requesting informal input on combination product designations.”

“Enzyvant receives FDA breakthrough therapy designation for investigational therapy rvt-802,” Reuters

“Enzyvant receives FDA breakthrough therapy designation and regenerative medicine advanced therapy designation for investigational therapy rvt-802.”

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