This week’s headlines include: U.S. approves Roche drug that targets severe form of MS, Thermo Fisher Scientific and the Cell and Gene Therapy Catapult Collaborate to Optimise Advanced Therapy Supply Chain, Are right-to-try laws a last hope for dying patients — or a false hope?, Parker Institute, BMS, and CRI Partner on Immuno-Oncology Research, Takeda’s Dengue Vaccine Candidate Elicited Broad Immune Responses in Children and Adolescents Living in Dengue-Endemic Areas, Double Pancreatic Cancer Surprise For Erytech’s Graspa, Chinese drug approval boosts AstraZeneca’s lung cancer hopes, and Myeloma UK launches ‘world first’ immunotherapy trial.
In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:
We recently finished our Ask the Expert discussion, “Maximizing Transient Protein Production”. During this Ask the Expert session, we discussed factors that influence transfection, troubleshooting, and optimizing productivity. Specific topics included host cell choice, target types, factors that impact transfection efficiency, increasing titers, and improving quality…
Kinetic binding and characterization of biotherapeutic candidates is an important part of screening and selection during drug discovery. The ease and speed with which this information is obtained directly affects decisions about whether a candidate is suitable for further research. Thus there are important considerations to be made when choosing a method for analyzing biophysical data…
Viral vectors are highly valued in many therapeutic fields given the promise of low cost and safe manufacturing coupled with high product efficacy and an excellent safety profile. Engineered with the use of molecular biology tools, viral vectors from well-known natural viruses such as adeno-associated virus (AAV), lentivirus, adenovirus, or modified vaccinia ankara (MVA) have been explored for several decades. Scientists utilize these vectors predominantly to carry desired genetic material into cells or tissues with the purpose to correct genetic deficiencies or elicit host immune responses against either self-antigens (cancer) or foreign antigens (microbial, parasitic or viral pathogens)…
Ever since the derivation of the first line of human embryonic stem cells, researchers in areas of regenerative medicine, basic biomedical research, and drug discovery have all been striving towards more reliable and reproducible procedures to culture human pluripotent stem cells (hPSCs) and/or differentiated cells. Years of development have resulted in more defined culture methods, and although major media improvements have been made, undefined culture substrates are still being used and few are natural and cell type specific…
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…
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…
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…
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 – April 4, 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
“Roche’s multiple sclerosis (MS) drug Ocrevus won U.S. approval, putting the potential blockbuster back on track after a brief delay and giving a lift to patients with a form of the disease that until now had no approved treatment. The drug, also known as ocrelizumab and administered via infusion, becomes the first U.S. Food and Drug Administration-approved medicine for the primary progressive form of the neurological disease (PPMS)…”
“Thermo Fisher Scientific and the Cell and Gene Therapy Catapult Collaborate to Optimise Advanced Therapy Supply Chain,” Business Wire
“To help address the challenges surrounding supply chain management for cell and Gene Therapy around the globe, Thermo Fisher Scientific, the world leader in serving science, today announced a collaboration with the Cell and Gene Therapy Catapult (CGT Catapult) to provide developers with both the manufacturing capability and distribution, logistics, and storage capacity needed to create a seamless supply chain to accelerate cell and Gene Therapy development and commercialsation…”
“Where’s Jordan?” asked Vice President Pence as he walked into the White House meeting of terminally ill patients and their families. All eyes shifted, and Pence made a beeline for a 7-year-old boy from Indianapolis with a broad grin. Back home, when Pence was Indiana’s governor, Jordan McLinn and his battle with Duchenne muscular dystrophy had helped inspire passage of a state “right-to-try” law intended to give the desperately ill access to medications not yet approved by the Food and Drug Administration. Fast-forward to Washington, where Pence is now in a position to encourage national right-to-try legislation…”
“The Parker Institute for Cancer Immunotherapy, Bristol-Myers Squibb (BMS), and the Cancer Research Institute (CRI) said today they will partner to speed up discovery and development of new immuno-oncology treatments. The value of the multiyear clinical research collaboration was not disclosed. BMS becomes the first biopharma to partner with the Parker Institute and CRI. The company said it will solicit clinical research proposals from the Parker Institute and CRI researcher networks, as well as coordinate multisite clinical studies aimed at what the company calls the most difficult questions in cancer research…”
“Takeda’s Dengue Vaccine Candidate Elicited Broad Immune Responses in Children and Adolescents Living in Dengue-Endemic Areas; Interim Phase 2 Analysis Published in The Lancet Infectious Diseases,” Yahoo Finance
Takeda Pharmaceutical Company Limited [TSE: 4502], (“Takeda”) today announced that data from a 6-month interim analysis* of the ongoing DEN-204 trial of its live-attenuated tetravalent dengue vaccine candidate, TAK-003 (also referred to as TDV), have been published in The Lancet Infectious Diseases…1
“A glimmer of hope against pancreatic cancer has come courtesy of Erytech (OTC:EYRYY), a little-known French biotech, which appears to have extended the asparagine synthetase hypothesis to this extremely failure-prone cancer type. The success was doubly unexpected: after hedging its bets with patient selection, Erytech suggests that Graspa, the project in question, in fact, worked in all comers. A major caveat, however, is that Graspa’s precise significance on the primary endpoint is unclear, which could call into doubt broader data analyses…”
“AstraZeneca has won approval for its lung cancer pill Tagrisso in China, a key market for the potential blockbuster medicine. Tagrisso is designed to help cancer patients with certain genetic mutations that are very common in China and the regulatory green light boosts the British drugmaker’s prospects in a key therapy area…”
“Myeloma UK has launched a ground-breaking immunotherapy trial which aims to modulate the immune system to target myeloma. In what the charity describes as a “world first”, the Phase Ib study, called MUK eleven, will investigate Oncolytics Biotech’ oncolytic virus Reolysin (pelareorep) in combination with immunomodulatory drugs as a rescue treatment in relapsing myeloma patients…”