This week’s biotechnology news headlines include
Shire Expands Kendall Square Footprint with Rare Disease Innovation Hub, Automating 3-D Cell Culture and Screening by Flow Cytometry and High-Content Imaging, Summer Project Turns Into Leukemia Testing Breakthrough, Novartis buys U.S. blood disease drugmaker in $665 million deal, U.S. House passes 21st Century Cures health bill, After Juno deaths, Bluebird posts positive CAR-T safety, efficacy signals, and Nestlé Reformulates Sugar and Says It Will Use Less in Its Candy.
Cell Culture Events
Presenting a case study that reduces MAb clinical trial development costs by up to 65% using different agarose Protein A chromatography resins
Wednesday 7th December | 14:00 GMT
On Wednesday 7th December, Purolite’s Life Sciences will host a webinar to present a case study that reduces MAb clinical trial development costs by up to 65% using different agarose Protein A chromatography resins.
- New data from a HTPD comparability case study will be shared using three Protein A’s performed on a Perkin-Elmer Janus® BioTx Pro Plus Workstation
- Assessed with Alvotech Biopharmaceuticals supplied biosimilar MAb feedstock
- Key data includes yield, purity, DNA & HCP clearance and protein A leakage.
In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:
Finding the right combination of cell culture media ingredients can be tricky and it isn’t always simple to find an off the shelf medium that meets all your requirements. Sometimes it takes several clicks around to locate one that will meet your needs. To address this challenge we’ve created an online cell culture media formulation tool.
Chemically defined media is used in many biomanufacturing operations. In this week’s Two Minute Tuesday video, Tom Fletcher, Director, Cell Culture R&D, Irvine Scientific is interviewed on his thoughts regarding the impact of chemically defined media on product quality. Mr. Fletcher shares his experience on using media components and varying concentrations to impact product quality, particularly post-translational modifications like glycosylation. He also shares that there is a balance between protein quality and quantity and that the goal is to find the optimum balance, so you have the highest quantity possible, while still maintaining the quality level.
Digital Biomanufacturing (DB) promotes improvements in the manufacturing of biologicals by using computer-aided design and manufacturing. Now, it’s important to not confuse this idea with the so-called direct digital biomanufacturing. Direct digital biomanufacturing describes types of processes employed in some synthetic biology and 3D bioprinting operations. In fact, we can think of bioprinting as one example of direct digital biomanufacturing. Bioprinting uses computer algorithms and models to deposit fluids containing living cells and structural matrix components to build tissue-like constructs.
Since the early days of cell culture, scientists have typically relied on serum supplementation in their cell culture media, most often in the form of whole bovine or human-derived serum or isolated components/fractions thereof. This ill-defined mixture of proteins, small molecules, and other factors has served as a physiological crutch compensating for our limited understanding of the complex ingredient interactions required for in vitro propagation of mammalian cells. As cell culture-based therapeutics have transitioned from bench research to clinical trials at bed side, they have established the desperate need for a great “cell cultural enlightenment” – and our days of blissful ignorance must come to an end.
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.
- ASCB – December 3-7, 2016 – San Francisco, CA http://ascb.org/meetings/
- World Stem Cell Summit & RegMed Capital Conference– December 6-9, 2016 – West Palm Beach, Florida http://worldstemcellsummit.com/
- Antibody Engineering and Therapeutics – December 11-15, 2016 – San Diego, CA http://www.ibclifesciences.com/AntibodyEng/overview.xml
- Global Biomanufacturing Summit – December 12-14, 2016 – San Diego, CA http://biomansummit.com/
“After just a short time in Kendall Square, Cambridge, MA, Shire likes the area so much that they are expanding to a second site at 500 Kendall Street to create a 550,000-square-foot campus focused on rare diseases. Earlier this month Shire confirmed its focus on rare diseases during an investor presentation.”
“Automating 3-D Cell Culture and Screening by Flow Cytometry and High-Content Imaging,” American Laboratory
“For over half a century, researchers have used 2-D cell culture methods, though the physiological relevance of these models has frequently been in doubt, largely because mono layer culture systems cannot replicate in vivo conditions. By way of contrast, 3-D cell cultures help elucidate more about cell morphology, motility, polarity and response to stimuli. The spheroidal structure of many 3-D cultures creates diffusion gradients that mimic solid tumors, and therefore provides cancer researchers with a more useful drug response model.”
“A rare but treatable form of cancer can now be diagnosed cheaply and easily with dried blood spots instead of whole blood, scientists in Seattle announced last week.The new test for chronic myeloid leukemia can be run with a few dime-size spots on a paper card that can be mailed to a center for diagnosis.”
“Novartis (NOVN.S) is buying U.S.-based Selexys Pharmaceuticals in a deal worth up to $665 million, the Swiss drugmaker said on Monday, expanding its pipeline of medicines to combat blood diseases.”
“The U.S. House of Representatives on Wednesday passed a sweeping, $6.3 billion bill that supporters say will spur medical innovation, speed access to new drugs, expand access to mental health treatment and battle the opioid epidemic.”
“CAR-T biotech Bluebird Bio has released topline data for its experimental med bb2121 in heavily pretreated multiple myeloma in a small, positive study that has not shown the serious side effects and deaths associated with Juno’s recent test of a similar treatment.”
“Call it sugar lite. Nestlé, the international food behemoth, announced Wednesday that it had developed a way of restructuring sugar, allowing the company to reduce the amount of sugar in its candy products.”