Preparing for future bioprocessing challenges with the Cellca CHO Expression Platform

Therapeutic protein development and production is a very technically challenging, time consuming and expensive endeavor.

What are some of the challenges? There are numerous critical decisions that must be made with regard to mammalian cell line choice (CHO, NS0, etc.), appropriate gene and marker expression systems, cell culture medium and feed optimization, clone selection and scale-up strategies. Biopharmaceutical developers should be careful to choose options which deliver the following:

• Maximum protein titer
• Scalability (5L – 1000L)
• Long-term Stability
• Cost effectiveness
• Shortened development timelines
• No burdensome IP concerns

Why is it important and critical to understand these challenges? There are considerable economic considerations to be made; one should maximize financial budgets by minimizing expenditures on equipment and technologies required for in-house development and characterization of the therapeutic protein. It’s important to make efficient and productive investments in R&D; technology and process development requires highly trained and expert staff. There are also commercial or market considerations which will affect return on investments; to maximize IP and patent life the therapeutic protein must be developed and commercialized as quickly as possible to gain maximum market share in a highly competitive environment. First to market is paramount for biosimilar developers.

How has the CRO industry responded? “Turn-key” cell line development and bioanalytical testing CROs are currently open for business and accessible for outsourcing nearly all upstream, downstream and biomolecular analytical activities. Sartorius Stedim Biotech offer the most comprehensive, scalable and unique bioprocess portfolio to support Biosimilar development and manufacturing. With Sartorius Stedim Biotechs’ recent acquisition of Cellca (cell line development) and BioOutsource (bioanalytical and biosafety testing), there is now established a fully functional, and integrated CRO uniquely positioned to support clients development programs across the entire product lifecycle.

The result of outsourcing biopharmaceutical development and production to experienced CROs will have major positive implications for shortening the time to commercialization at significantly reduced costs.

To learn more about the industry leading Cellca CLD platform which delivers stable, high titre clones, (95% of projects have delivered titres >3.0g/litre) in a proven scalable fed batch manufacturing process in a cost and time efficient manner please join our talk by Dr. Brian Wendelburg at IBC Cell Line Development & Engineering Conference, San Francisco, 14th June at 1.25pm.

Author Bio:


Dr. Brian Wendelburg received his Ph.D. in Molecular Biophysics from the Institute of Molecular Biophysics at Florida State University. He then completed his postdoctoral training at the University of North Carolina’s Lineberger Comprehensive Cancer Center. His professional career has involved diverse roles in sales and business development activities at leading Biotech companies such as Cepheid, Affymetrix and Miltenyi Biotec where he gained a strong technical background in genomics, proteomics and cell and gene therapy applications. He joined the Sartorius-Stedim Biotech team in the spring of 2016 and is currently Sr. Field Marketing Manager for the BioOutsource and Cellca divisions.

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Tough Economy Slows Down CRO Growth for now

According to this article in Clinical Trials Today recent layoffs in the pharmaceutical industry has slowed down CRO growth in short term, but in the long run improving efficiency and controlling costs will result in more opportunities for CROs.

Oncology is expected to become a huge focus in the future, so CROs with strong oncology franchises should reap the benefits from that trend soon. It is said that the oncology market will grow to approximately $80 billion in global sales by 2012. European CROs are also making headway as the two Italy-based CROs, Phidea and Marvin Research have completed their merger.

What are some other trends that can help boost CRO growth in the near future?

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How to rescue a clinical trial

At ClinPage, they recently posted an article about the keys to resuming a clinical trial if you've taken over it midway through the process. So what should you do if you're asked to resume a project after everything's been started?

They suggest:
1) Assess and plan
2) No rushing
3) Create trust
4) Initial Visits
5) Ongoing oversight

For an in-depth look at the steps, read the article here.

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PPD Extends its Reach to Eastern and Central Europe

According to this article in novinite.com PPD is set to buy AbCRO, which is Bulgarian based CRO, in order to expand its drug testing businesses in Eastern and Central Europe.

The purchase which is expected to be completed in March will add Romania, Bulgaria, Serbia and Croatia to PPD’s operations in Europe and also help bolster its already existing operations in Poland, Russia and the Ukraine. What other clinical trials companies are investing heavily in Eastern and Central Europe?

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Live from Central Labs: Day 3

Central Labs Partnering event closed today which a motivational keynote from Lou Ferrigno. Pharmaceutical executives listened as Mr. Ferrigno explain how becoming fearless and taking strategic risk in this economy will lead to true success and breed innovation. In the afternoon, Wendy R. Sanhai, PhD, Senior Scientific Advisor, Office of the Commissioner, FDA; Samir Khleif, Head, Cancer Vaccine Section Investigator, NIH; William Wheeler, MD, FAAC, Global Medical Director, Centralized Cardiac Services, MDS PHARMA SERVICE; and Patrice Hugo, Vice-President of Scientific Affairs, MDS PHARMA SERVICES provided innovated strategies for working together to develop biomarkers for safety monitoring and surrogate endpoints.

IIR would like to thank all of those who attended and invite you to comment here on the event. We are looking for ideas on where to hold next year’s meeting and welcome your feedback here.

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Live from Central Labs: Day 2

Today, was the second day of IIR’s Annual Partnering with Central Labs event. Kenneth Kaitlin, PhD, Director and Professor of Medicine, TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT, kicked off the meeting with a dynamic and engaging talk that discussed the current environment for pharmaceutical innovation, Tufts CSDD’s Annual Report on Trends in Drug Development, and new R&D strategies. The audience then heard J. Rick Turner, PhD, President and Chief Scientific Officer, TURNER MEDICAL COMMUNICATIONS, discuss Drug Safety Evaluation with a focus on benefit-risk assessments throughout development and therapy

which was followed by the grand opening of the Labs networking hall. The hall houses over close to 50 companies representing the nation’s leading central labs, imaging and ECG labs, in addition to numerous CROs and ancillary service providers.

This afternoon, participants broke into three tracks on Central lab Relationship Development, Standardization in Imaging Studies, and Improving & Standardizing ECG and Cardiac Safety Studies in which multiple panel sessions allowed for open discussions and debate. Participants were engaged, asking lots of questions to get the answers to their most pressing challenges in managing outsourcing lab partnerships.

The day closed with a reception hosted by the conference sponsor Esoterix. The Central Labs participants attended and visited with their outsourcing partners and looked for new services with some of the event new exhibitors including MNX Global LifeScience Logistics and diaDexus.

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Live from Central Labs: Day 1

IIR’s 7th Annual Central Labs Partnering with Central Labs, ECG, & Imaging Labs opened today at the Red Rock Resort and Spa in a Las Vegas, NV. In the wake of the news that will likely be the biggest deal of 2010, Pfizer’s acquisition of Wyeth, experts convened to discuss and share best practices partnering strategic Small Pharmaceutical Companies and uncover the latest strategies in biomarkers, personalized medicine, diagnostics and assay development.

Over 250 outsourcing executives from large and small biopharmaceutical companies including Amgen, Pfizer, Novartis and Celgene convened with the world’s largest central labs including Icon, Covance, and MDS Pharma Services.

Monday’s attendees heard about innovative ways to better manage outsourcing partnerships and improve and streamline clinical trials operations. In addition, they received a deeper understanding of the how new developments in biomarkers, personalized medicine, diagnostics and assay development will change the face of drug development in the immediate future.

The day closed with a wonderful reception hosted by Huntingdon Life Sciences. Dr. Douglas King, Director of Business Development for DCL Medical Laboratories said to one of the conference organizers “This is such a great event. You can look around the room and see deals being made!” Despite concerns about the economy and continued mergers the buzz was great as participants recognize that as large pharma continues to downsize their workforces outsourcing will continue to be a go to strategy for the long haul. Finally, after the close of the reception attendees left for the evening to meet one on one with their partners and take advantage of the beautiful casino at the Red Rock.

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