This week’s headlines include: Merck leapfrogs rivals in lung cancer drug combination race, Biotech Deals Will Bounce Back in 2017, A Genetically Modified Malaria Vaccine Has Passed an Important Hurdle, Neon Therapeutics Hauls in $70M for Personalized Cancer Vaccines, Novartis joins forces with Ionis on cardiovascular treatments, and Bavarian Nordic sees ‘huge potential’ in cancer vaccine combos, CEO says.
In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:
Cell culture media optimization continues to play a critical role in both increasing titers and providing a mechanism for modifying protein quality. One way to optimize media is to include supplements that improve productivity or protein characteristics. As a result, there is an interest in developing novel animal-free supplements that can impact these processes for both mammalian and microbial culture. It is important to note that supplements chosen to enhance media can have dramatic effects, both positively and negatively, on productivity, growth and protein quality. This highlights the importance of understanding what the drivers of the cell culture process are in order to identify appropriate supplements.
As the Cell Therapy industry increasingly moves from research to clinical trials and commercial manufacturing, it is necessary to scale up manufacturing processes to meet increasing product demand. Clinical and commercial manufacturing also requires that the manufacturing process be compatible with quality and regulatory expectations to ensure safety.
Increasingly, companies are choosing CHO-based transient production of antibodies in early biopharmaceutical development over stable cell line generation. The advantage of using transient transfection is that it takes significantly less time and cost to generate material when compared with the alternative of developing a genetically stable cell line for manufacturing. This is particularly important in drug development where preclinical material is needed quickly in order to make informed go/no go decisions. Having access to preclinical material faster and with less cost can greatly impact the overall drug development timeline.
Cells of the immune system, including macrophages, dendritic cells, B cells, T cells, and NK cells are actively being used for many research and therapeutic applications. Cell Therapy, immunotherapy, and drug discovery are just a few areas where the culture, expansion, and differentiation of these immune cells is especially utilized. However, this culturing process is not trivial. Maintaining, differentiating, and expanding immune cells can be difficult. In addition, many scientists use immune cells in their cross-disciplinary research. While these scientists are experts in their area of research, they are often not experts in culturing immune cells, in particular, the methods used to differentiate and expand them in culture.
As part of our Boston Biotech Week 2016 coverage, we will be writing about some of the posters presented at the conference. One poster that caught my eye for downstream was presented by Oncobiologics and JSR Life Sciences, “Optimization of a Protein A Chromatography Process for a Herceptin® Biosimilar (Trastuzumab).” In the poster, Oncobiologics and JSR Life Sciences describe the steps taken in identifying the most efficient chromatography process.
Only 1 out of each 50 biopharmaceutical new product candidates makes it through the research phase into clinical trial testing and subsequently to the market. This high attrition rate is predominantly in the early development phases and is attributed to (I) undesired pharmacokinetics profile (39%), (II) lack of efficacy (30%), (III) in vivo toxicity in preclinical model (11%), (IV) adverse effect in humans (10%), and (V) other reasons, of which most commonly commercial arguments based on cost of goods (10%). It is therefore imperative that technologies become available that allow significant de-risking of biopharmaceutical product trajectories in the early research and development phase. The importance of this has been recognized by the field with the introduction of the “Design of Experiments” (DoE) approach, identifying critical quality attributes and performance attributes like yield, glycosylation, potency, and consumable costs of a manufacturing process. Owing to the DoE approach, scientists now have a tool to strategize the development of a novel product candidate. That said, it is often found that due to the complexity of many novel molecules, the number of parameters that need to be tested still requires vast numbers of experiments which are time consuming and costly.
At this year’s Boston Biotech Week the 2016 BioProcess International Award Winners were announced. These awards recognize outstanding achievements in the area of biotherapeutic development and manufacturing processes. This year individuals and companies that made significant contributions to improving biotherapeutics were recognized. Novel technologies in upstream, downstream and analytical application areas were also awarded. I have listed the winners and finalists along with a brief description of the winning achievements for downstream technologies here. For a list of upstream and analytical technology winners, please see 2016 BioProcess International Award Winners – Upstream and Analytical.
Because Protein A is a valuable resource in any mAb purification strategy, companies often search for ways to improve the productivity of their affinity chromatography step. One strategy worth further investigation is variable column loading. By varying residence time (RT) over the loading phase, productivity from an affinity chromatography step can be significantly improved.
Merck & Co has pulled ahead of rivals in the race to combine immunotherapy with other drugs as a treatment for lung cancer, potentially giving it a major lift in the battle for the largest cancer market.
Biotech could really use the clean slate of a New Year. The Nasdaq Biotech Index collapsed 28 percent in the opening weeks of 2016 and never fully recovered, ending the year down about 22 percent.
It seems a primitive way to fight one of the world’s worst diseases, but 10 volunteers have been bitten by malaria-carrying mosquitoes in an effort to test out a new kind of genetically modified vaccine. So far, so good: no one got sick, and all 10 subjects developed antibodies, suggesting the new vaccine was doing its job.
One of the challenges of enlisting the body’s immune system to fight cancer is the constant mutation of the disease. If the body’s immune cells don’t recognize the cancer, they can’t target tumors effectively. Neon Therapeutics believes it has developed a way to make cancer vaccines that recognize and respond to these tumor changes. Now the biotech company has $70 million in new funding to advance its work.
Novartis has agreed with Ionis Pharmaceuticals Inc and its affiliate Akcea Therapeutics Inc to license two experimental cardiovascular treatments in a deal which Ionis said could eventually be worth more than $1 billion.
As interest in cancer vaccine combos surges, Bavarian Nordic is inclined to remain an independent vaccine company, according to CEO Paul Chaplin. That’s because, he says, it’s the “best and most fruitful way” to get the most out of the company’s platform in a variety of disease targets.