The Dish’s Weekly Biotechnology News Wrap Up – November 18, 2016

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.

Register Now

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

Digital Biomanufacturing Will Enable Tissue Bioprinting

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.

Video – When and Where to Optimize Cell Culture Media

Cell culture media optimization is a critical step in any biomanufacturing process. In this week’s Two Minute Tuesday video, Tom Fletcher, Director, Cell Culture R&D, Irvine Scientific is interviewed on his thoughts regarding media optimization. Mr. Fletcher provides insight on the importance of cell line, media optimization and process parameters to a successful process. He also discusses the best time to engage in media optimization projects and what is on the horizon for media development.  For the full interview, please see the video below titled, “When and Where to Optimize Cell Culture Media an Expert Interview with Tom Fletcher.”

Pumping Iron – But Not in the gym: The Critical Roles of Transferrin in Cell Culture Media

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.

Solve Production Challenges of Difficult to Express Proteins with Scalable, Continuous Manufacturing

At this year’s Boston Biotech Week there were many interesting talks on continuous biomanufacturing and associated new technologies. In particular, there was a great deal of discussion around how to handle difficult to produce proteins. These manufacturing challenges included proteins that were difficult to express and/or were unstable. One very interesting talk, given by Scott Waniger, Vice President, Bioservices Division, Cell Culture Company, was titled “Solving Production Challenges of Difficult-to-Express Proteins with a Scalable, Continuous Manufacturing Bioreactor: A Case Study” and focused on the use of perfusion bioreactors (hollow fiber) to create both continuous upstream production and address the issue of cost effective manufacturing of difficult to express proteins.

Cool Tool – SCOUT® technology reduces time to market and increases chance of success for biopharmaceutical products

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 costl

2016 BioProcess International Award Winners – Downstream and Facilities

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.

Gain Productivity in Protein Purification through Column Loading Optimization

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.

Boston Biotech Week 2016 – Downstream Coverage – In case you missed it!

This year was the first year that the BioProcess International Conference (BPI East) became Boston Biotech Week and incorporated a Cell Therapy track. I was excited to attend and to see what the format for the new conference was going to be. I felt that the content was very relevant and covered a wide breadth of topics, from cell culture to commercial manufacturing and I was particularly interested to see how this translated to Cell Therapy. Overall Boston Biotech Week delivered talks focused on improving the manufacturing process for biopharmaceuticals and cell therapies, enabled industry networking opportunities, and provided the chance to see the latest products and technologies.