This week’s headlines include: Merck’s Keytruda wins FDA nod for treating blood cancer, Vaccine Makers Ranked on Pricing and Research, BIO, Pew Weigh FDA’s Revised Draft Guidance on Mixing, Diluting or Repackaging Biologics, Vedantra, Neon Launch Cancer Vaccine Research Collaboration, F.D.A. Official Under Bush Is Trump’s Choice to Lead Agency, and Allergan signs deal with Editas for gene-editing-based eye treatments.
In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:
The Human Protein Atlas (HPA) project was initiated in 2003 with the goal to systematically map the expression of these proteins using antibody-based proteomics. The program is based primarily in Sweden with funding from the non-profit organization Knut and Alice Wallenberg Foundation (KAW). Antibodies, produced in-house and commercially purchased, are first validated by the researchers and then used to characterize each protein. The data is available through an open-access interactive database: www.proteinatlas.org (the first version was launched in 2005). It contains millions of high-resolution images showing the spatial localization of protein expression in 76 different cell types within 44 different normal human tissues (Tissue Atlas) and 20 different cancer types (Cancer Atlas)…
Mesenchymal stem cells were originally developed for medical purposes to improve wound healing. They were then found to have significant immune effects, primarily immune suppressant and tolerance inducing effects. There are successful reports of using MSCs to treat animal models of a number of autoimmune diseases. Mesenchymal stem cells can be derived from many different sites, including bone marrow, dental pulp, adipose tissue and umbilical cords. In our studies of murine models of lupus, umbilical cord-derived MSCs had the best therapeutic profile compared to bone marrow derived MSCs from controls…
Recently, Cell Culture Dish has published several poster and webinar articles discussing the use of MaxCyte’s electroporation-based delivery platform for cell engineering, specifically in the areas of transient and stable protein production. There was a high level of interest from readers regarding CHO-based, gram-level protein production, and so during this week’s Ask the Expert session, we will be joined by Dr. Weili Wang, the Director of Cell Culture at MaxCyte, to answer questions regarding cell engineering and culturing that can maximize transient protein production. Dr. Wang has over 20 years of biopharma industry experience focusing on process development, stable cell line generation, tech transfer and scale up/scale down modeling to support cGMP manufacturing. Prior to joining MaxCyte, Dr. Wang was the upstream manager at Human Genome Sciences, MacroGenics and Amplimmune. Dr. Wang received his Ph. D degree from Texas A&M University, a Master degree from Florida International University and Bachelor degree from East China University of Science & Technology…
We began the podcast with a brief introduction from Fabien Moncaubeig on vaccine and viral vector manufacturing. In this introduction he discussed that the protocols for vaccine and viral vector manufacturing are similar although vaccine manufacturing has a longer history. Both have used adherent cell lines in cell factories or roller bottles. The challenge with these systems is that in order to increase volume you have to scale out rather than scale up. In scaling out you increase the number of pieces of equipment, the overall manufacturing footprint, and the number of employees needed for operation, thus the cost doesn’t decrease significantly…
Protein A is by far the most common purification method in biopharmaceutical manufacturing. Due to its high affinity and selectivity for therapeutic antibodies, high purity can often be reached in a single step. With the expanding market for therapeutic antibodies, pressure to reduce the cost of pharmaceuticals, and increases in upstream production titers; Protein A improvements have been required to meet industry demands for improved downstream purification efficiency…
Due to a paradigm shift in the pharmaceutical industry, there is rising pressure to come up with faster, more cost- effective ways to produce drugs for the patients who need them. As orphan drugs and personalized medicine begin to replace traditional blockbuster products, pharmaceutical companies are looking at new and innovative ways to quickly and efficiently deliver drugs to target populations in the thousands rather than the millions. In addition, the need for lower drug prices has been pushed into the spotlight not just by regulators, but also by the advent of biosimilars. As a result of these changes, industry experts must find a way to produce drugs that address the issues around both drug pricing and time to market while also maintaining quality and profits…
In a recent white paper, the issue of improving downstream efficiency was explored. The paper, “Unlocking the Potential for Efficiency in Downstream Bioprocess,” published by GE Healthcare Life Sciences, described techniques like continuous processing, in-line conditioning buffer preparation, and system automation as tools to improve the overall efficiency of downstream processes while at the same time eliminating bottlenecks and facility fit issues. I have summarized the highlights of the paper in this article. Biomanufacturing is constantly evolving due to changing industry demands and new technologies that enable advancement. Industry goals are now primarily focused on reducing cost and improving throughput, productivity, time to market and flexibility. These goals must be met whilst maintaining the highest levels of product quality and safety requirements. With increased titer, downstream processes have had to manage higher titers and greater impurities than they were originally designed for. Thus downstream processes must also be improved to create an entire manufacturing process that is more streamlined and meets industry goals…
The use of Protein A affinity chromatography is commonplace in biopharmaceutical manufacturing, with 95% of all commercially available MAbs using Protein A purification. High purity is achieved in one step (around 99%), but it is well recognized that the cost of Protein A resins is substantial. If a product makes it to marketing approval and manufacturing these costs are amortized over a large number of purification cycles and the contribution to cost of goods is acceptable. However, a high percentage of clinical projects will fail, resulting in the Protein A resin only being used for a small number of cycles – significantly reducing cost-efficiencies…
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
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.
Accelerating the development of regenerative therapies: Large scale expansion of human mesenchymal stem cells – March 28, 2017
Pall has partnered with RoosterBio to commercialize Allegro™ Unison human mesenchymal stem cells (hMSCs) and bioprocess media to accelerate Cell Therapy and regenerative medicine development. Use of Allegro Unison products along with SoloHill microcarriers, Allegro biocontainers, and the PadReactor® bioreactor system moves the industry towards execution of the technology roadmap to achieve lot sizes of 100s of billions to >1 trillion hMSCs, without the need for extensive and costly process development. Large scale hMSC expansion is now rapidly achievable in a robust, scalable, reproducible, and economic manner.
This webinar details the total solution for large scale expansion of human mesenchymal stem cells. We will present a case study highlighting large scale cell culture and expansion of hMSCs to billions of cells, within ten days of culture, in a fed-batch 50L bioreactor system.
Register to Learn:
- How Allegro Unison hMSCs and bioprocess media, SoloHill microcarriers and Pall PadReactor systems enable large-scale hMSC expansion.
- Culture protocol for 200-fold hMSC expansion, within 10 days, in a single-use, fed-batch scalable manufacturing platform.
- How regenerative medicine and Cell Therapy developers can rapidly and economically move towards producing tens of billions to >1 trillion high quality hMSCs for product development programs in single-use bioreactors.
The success of developing a cellular therapy rests on the ability to deliver a viable, potent product. This positive end-result is directly attributable to the strategy in place and the supporting processes. A reliable Cell Therapy development strategy is imperative to ensuring your therapeutic materials remain viable from the point of collection, through manufacture, to the final clinical site delivery.
This webinar will review some of the key components to consider when developing your strategy to minimize risk, manage cost, and ultimately deliver a product to market.
Key Learning Objectives:
- Minimizing variability through the use of collection and administration kits and SOPs
- Understanding the importance of validating process and qualifying equipment as well as data collection early and throughout Study/Phase 1 to commercial
- Leveraging data to maintain cell integrity, improve process, reduce risk, analyze and strengthen weak points
- Maintaining chain of custody and real time communications
- Understanding the importance of tracking and monitoring to ensure the right patient receives the right material at the right time
- Considering scalability from Day 1
“Merck & Co Inc said on Tuesday it had got a nod from the U.S. Food and Drug Administration for its already-approved immunotherapy drug Keytruda as a treatment for a type of blood cancer. The nod from the FDA marks the first approval of the treatment for blood cancer. Keytruda is already approved for treating lung, head and neck cancers, among others.”
“The pharmaceutical companies GlaxoSmithKline and Sanofi sell many doses of vaccines at high prices and do a lot of research with the profits, while the Serum Institute of India makes more doses than any other manufacturer and sells them at low prices, according to the first Access to Vaccines Index, which was released last week.”
“BIO, Pew Weigh FDA’s Revised Draft Guidance on Mixing, Diluting or Repackaging Biologics,” Regulatory Focus
“The Biotechnology Innovation Organization (BIO) and the Pew Charitable Trusts are offering their input on the US Food and Drug Administration’s (FDA) recently revised draft guidance on mixing, diluting or repackaging biologics. While both organizations say the revised draft guidance is a step in the right direction, BIO says several aspects of the guidance still raise concerns.”
“Vedantra Pharmaceuticals said today it will partner with Neon Therapeutics to develop cancer vaccines, through a nonexclusive research collaboration whose value was not disclosed. The companies will explore combining Vedantra’s albumin-binding, lymph node-targeting amphiphile technology with Neon’s capabilities in neoantigen vaccine research. The objective of the joint research collaboration, Vedantra said, is to continue development of therapeutic vaccines that raise immune responses against neoantigens that allow the body to naturally expand immune cells capable of destroying infected or cancerous cells, without harming normal tissues.”
“President Trump said Friday that he intended to nominate Scott Gottlieb, a partner at a venture capital fund with longstanding ties to the pharmaceutical and biotech industries, to lead the Food and Drug Administration.”
“Allergan plc said on Tuesday it would get exclusive access and the option to license up to five of Editas Medicine Inc’s experimental gene-editing-based eye treatments under a research and development deal between the two companies.”