This week’s biotechnology news headlines include
Which Big Drug Companies Are Helping the Poor, EMA Revises Guideline on First-in-Human Trials, Novartis leukemia drug wins FDA priority review, Pfizer and NCI to Study Three Cancer Immunotherapy Candidates, EU Panel Recommends Orphan Drug Status for ALS Therapy Ibudilast, Janssen seeks FDA approval for IL-23 blockbuster hopeful guselkumab, and Lilly’s Lartruvo get EU nod for soft tissue sarcoma.
Cell Culture Events
November 17, 2016, 11:00AM ET
Speaker: Lia Thornberry Kent, Technical Training & Scientific Support, Biological Industries USA
This webinar will provide a comprehensive overview of human pluripotent stem cell (hPSC) culture methods. Attendees will learn about the cells’ basic culture requirements and how aspects of the culture environment have developed over time, ultimately to defined culture systems widely used in disease research, and clinically-relevant systems amenable to downstream therapeutic applications. A review of various culture environments in use today will provide a high-level overview of the field and a basic understanding of the requirements for maintaining these unique cells.
This webinar is the first in a series of hPSC tips and techniques – Register Now
Thursday December 1st, 2016 | 9 am -10 am PST
Speaker: Marlin Frechette – Director Quality Systems/ Regulatory Affairs and ISO Management Representative
From pre-clinical research to commercialization, regulatory bodies expect that media used in regenerative medicine and Cell Therapy applications are manufactured using controlled and traceable materials to ensure lot-to-lot consistency and minimize the risk of contamination by adventitious agents. Irvine Scientific has extensive experience in regulatory compliance and we understand how critical it is to use a Quality by Design (QbD) approach during the design, development and commercialization of Cell Therapy media. Learn how to identify and implement the best practices and strategies for media development from our Quality and Regulatory expert, Marlin Frechette.
Topics covered will include:
- Quality by Design
- Raw material souring and qualification
- Supply chain management
- cGMP manufacturing
- Cold chain logistics
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:
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.
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.”
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.
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.
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
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.
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.
- 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/
“The pharmaceutical giant GSK, which has held first place in the Access to Medicine Index ever since its introduction in 2008, was ranked first again this week. The index measures how well the world’s top 20 pharma companies do at getting their drugs and vaccines — and often their scientific expertise — to the world’s poorest countries.”
“The European Medicines Agency (EMA), in cooperation with the European Commission and the EU member states, on Tuesday proposed revisions to its 2007 guideline on first-in-human clinical trials as part of an effort to further improve the safety of participants as trial protocols become increasingly complex.”
“Novartis’s investigational drug PKC 412 won U.S. Food and Drug Administration priority review, the Swiss drugmaker said on Monday, keeping up momentum after the prospective treatment for a fast-growing form of leukemia garnered breakthrough therapy status this year.”
“Pfizer said today it will collaborate with the National Cancer Institute’s Center for Cancer Research (CCR) to assess three immunotherapy candidates by arranging and conducting clinical and preclinical trials.”
“The European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) has issued a positive opinion recommending that ibudilast (MN-166) receives orphan medicinal product (orphan drug designation) for the treatment of amyotrophic lateral sclerosis (ALS).”
“J&J’s biotech arm has submitted its application to the FDA for its experimental med guselkumab in moderate to severe plaque psoriasis. Janssen said in statement this morning that the app for its mAb, which targets interleukin (IL)-23 – a protein which has been shown to play a key role in the development of immune-mediated inflammatory disease – is based on a series of recent mid-to-late-stage data.”
“Eli Lilly’s Lartruvo has received a conditional marketing approval by the European to treat soft tissue sarcoma (STS). Lartruvo (olaratumab) – the first monoclonal antibody to win regulatory clearance for treatment of the disease – can now be used alongside the chemotherapy doxorubicin in patients with advanced STS when surgery or radiotherapy is not suitable.”