spacer
home > ebr > spring 2018 > blood-free matters
PUBLICATIONS
European Biopharmaceutical Review

Blood-Free Matters

Since the advent of in vitro mammalian cell culture, fetal bovine serum (FBS) has been used to propagate cells ex vivo. FBS, when added to a basal media, provides facilitation of cell adhesion via extracellular matrix proteins, stimulation of cellular proliferation by the presence of growth factors and nutritional support through the presence of sugars, amino acids, and other undefined components (1). Thus, FBS has proven to be a vital facilitator in the progress of biological research through the years via the establishment of critical in vitro cell culture systems.

Although the addition of FBS to cell culture systems has broadly been adopted, its removal for R&D, as well as the expansion of cells and cell-derived products for therapeutic applications, has been recognised as a high priority among cell culturists for several reasons. Primarily, the introduction of an undefined substance to defined in vitro systems brings an unacceptable degree of unpredictability. Studies have demonstrated that different lots of serum can vary in concentration of known components in some cases more than 10-fold in addition to the variable presence or absence of undefined components (2). This type of variability can have profound effects on the outcome in cell culture systems (3).

Further, due to the degree of utilisation of FBS combined with absence of exact annual production volumes, adulteration and fraud has been wellnoted in the serum industry. In 1994, 30,000L of FBS were documented to be sourced from New Zealand. However, the country itself only reported 15,000L in annual production (4). A second major adulteration case in 2013 was recorded with the dilution of FBS with bovine albumin, water, and other growth promoting substances by a major global supplier (5). Subsequent investigations by the FDA concluded that approximately 280,000L of FBS were affected between 2008-2013 (5). In recent years, the progression of novel cell-based therapeutics from the research lab to the bedside has only further exacerbated the major issues with FBS. Primarily, largescale production of these novel therapies has further strained the already stretched FBS supply. Additionally, the presence of undefined factors in the expansion and production media can cause undesired phenotypic drift in the cell products, which could cause variable potency profiles of the final product that may be difficult to predict and control (6). Finally, since FBS is an animal-derived substance, patient safety is a persistent concern via the potential presence of adventitious agents (7).

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
Dr Randall Alfano is the Vice President of InVitria Product Development. He joined the company in 2012 and currently leads the product development team, where he utilises his expertise in media design and optimisation for biomanufacturing and stem/primary cells. Previously, Randall was promoted from Postdoctoral Fellow to Senior Scientist at the Cancer Research Institute of Scott and White Hospital where he developed in vivo animal models for metastatic prostate cancer and was instrumental in developing thorough in vitro and in vivo models for immunostimulatory antigens. He received his PhD from the Texas A&M Health Science Center College of Medicine, US.
spacer
Dr Randall Alfano
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Novo Nordisk Pharmatech A/S signs distribution agreement with DKSH for twelve countries in Asia Pacific

Novo Nordisk Pharmatech A/S and DKSH, have partnered to provide high-quality cGMP quaternary ammonium compounds in twelve countries across Asia Pacific
More info >>

White Papers

Systems Engineering for Complex Portable Medical Device Development

Phillips-Medisize

As the demand for complex, portable medical devices continues to grow, reducing risk and increasing efficiency during the development of these products should be paramount. Taking a systems-engineering (SE) approach to development provides a holistic, organized, and deliberate method for identifying as well as reducing both patient and business risks early in the process. Furthermore, it facilitates efficient progression throughout the entire product development life cycle.
More info >>

 
Industry Events

Clinical Trial Supply Europe 2019

13-14 March 2019, Milan, Italy

Following on from our largest and most engaging meeting to date, Clinical Trial Supply Europe will be returning to Milan for its 20th year in 2019! The 19th annual edition welcomed pharmaceutical companies across Europe who got together to share knowledge and issues regarding clinical trial supplies, both with regards to operational and technological challenges. Over the two days, delegates discussed issues which affected their business in our dedicated operational and technological streams.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement