In the United States, up to 40% of businesses affected by a natural or human-caused disaster never reopen (
1
). The biopharmaceutical industry is not immune from disasters of a dizzying variety. But biotechnology companies often put all their supply needs in one proverbial basket. Companies need to understand fully the ramifications of contingency planning for single product lines. Imagine having to set up distribution and shipping plans for multiple products with different environmental needs, for shipping to different markets, and so on.
Contingency planning for business is important for dealing with high-profile events such as Hurricane Sandy. Business continuity planning will guide a company safely to the other side. But contingency plans are just that —
plans
— so they need to be made
before
something happens. Organizations need to ask difficult questions ahead of time so that they can be as prepared as possible to handle problems head-on. Begin with the basics (Table 1), and then get into as mu...
As the biopharmaceutical market continues its global expansion, biomanufacturers are becoming increasingly comfortable with the idea of outsourcing activities to international destinations. This year, China expanded its lead as the primary potential destination. This measure of interest shows how the country’s international outsourcing potential and global perception have changed over the past five years. It also suggests a greater international awareness of opportunities opening up in China for local production.
More than a quarter (26.2%) of the 302 global respondents to our ninth annual survey indicated a “likelihood” or a “strong likelihood” that they would consider international capacity expansions to China over the next five years (
1
). For the second year, this puts China ahead of other leading destinations such as India (18.4%), Germany (16.9%), and the United States (16.9%), as Figure 1 shows.
US Companies Favor China
Analyzing respondents by geographical location, you find high interest among A...
Adecades-old technology is finally emerging from clinical laboratories and demonstrating its utility in drug discovery and development. Cell therapy researchers bring their laboratory experiences with them as their science is commercialized. And as biopharmaceutical production engineers incorporate quality by design (QbD) and process analytical technology (PAT) into their work, they find that a method for monitoring the state and distribution of living cells can help build valuable upstream process knowledge.
In flow cytometry, cells are suspended in fluid to flow along in single file through a laser beam. That light is scattered in patterns that provide information about the cells and their components. Sometimes fluorescent labeling — which absorbs and then reemits light at different frequencies — provides another dimension of analysis. When the scattered or emitted light is detected, it can be interpreted to describe the size and molecular characteristics of individual cells. With computer help, thousan...
Biotherapeutics have emerged as effective treatments for many diseases. It’s estimated that every year hundreds of new biotherapeutic candidates enter development (
1
). Stable transfection of host cells to establish high-producing cell lines is the approved method for generating clinical-grade recombinant biologics. However, biotechnology companies needing to speed up their developmental timelines are increasingly relying on material generated using transient transfection (
1
,
2
). Unlike stable gene expression (SGE) that requires several months of laboratory and process work, transient gene expression (TGE) generates milligram to gram quantities of representative therapeutic material in a matter of days (
3
).
HEK293 and CHO cells are two widely used hosts for TGE (
4
). The former produce significantly higher levels of recombinant protein than the latter in most such processes (
5
). That has led to widespread use of HEK293 as a more common host for transient transfections. But multiple cases have sh...
+4Mathematical modeling has been widely used in microbiology and biotechnology for several decades. The main objective of modeling is to find optimal conditions for microbial growth and biosynthesis of useful metabolites.
We modified the well-known equation of Perth–Marr (
1
) — proposed to calculate the energy consumption of a substrate— to analyze the energy consumption by cells for growth and viability maintenance. Our study includes that theory along with our own development. Our initial modeling work was carried out with
Yersinia, Pseudomonas, Pasteurella,
and
Salmonella.
For those studies, we created structured, unstructured, and general models (
2
,
3
).
Briefly, we now propose a general model that can be described as follows. Figure 1 shows a simplified scheme of the cell cycle in prokaryotes. Positions 1 and 5 (6) correspond to the boundary points of the cell cycle — a cell of zero age. In the literature, such cells are called
resting
or
dormant,
and we call them
stable cells
,
X
st
. Fo...
Insect cell culture is widely used as an industrial platform in recombinant protein production for research and diagnostics (
1
,
3
,
4
,
5
). Many commercial yeastolate products are intended as nutritional supplements for not only insect cell culture, but also for mammalian cell culture and bacterial fermentation applications (
6
,
7
,
8
,
9
,
10
,
11
,
12
,
13
,
14
,
15
). Yeastolate plays an important role in modern biological production because it can be very effective in promoting insect cell growth and enhancing production of recombinant proteins. The product is known to contain amino acids, peptides, vitamins, minerals, and carbohydrates. It also contains components that have not been characterized; the constituents responsible for cell growth promotion are still a mystery (
1
,–
2
).
Yeastolate is cost effective, not animal derived, and can enhance cell growth and recombinant protein production in serum-free culture systems. Yeast cells (
Saccharomyces cerevisiae
) are expanded for a designated t...
With a compound annual growth rate potential of ∼52% during 2010–2015 (
1
), the global biosimilars market represents a significant driver in biologics development and manufacture. Increased competition, quality-by-design (QbD) directives, and rising costs are compelling biosimilars manufacturers to search for advanced technologies they can use in optimizing production processes to remain competitive and maximize new opportunities. Here, we discuss biomanufacturers’ needs for robust, standardized cell-culturing procedures that comply with QbD directives. We also describe an effective new NMR-based bioanalysis technology.
Photo 1:
Photo 1: ()
PRODUCT FOCUS:
BIOSIMILARS
PROCESS FOCUS:
PRODUCTION
WHO SHOULD READ:
ANALYSTS, PROCESS ENGINEERS
KEYWORDS:
CELL CULTURE DEVELOPMENT, MEDIA, QBD, BIOSIMILARS
LEVEL:
INTRODUCTION
Biosimilars and the Biologics Market
According to
Global Biosimilars Market Forecast to 2015
, the biosimilars industry will continue to grow throughout the next few years, and patent ex...
IBC’s Biopharmaceutical Production Conference Series has offered high-quality programs covering topics from upstream to downstream for over 25 years. This series provides market-driven information, networking, and business development opportunities by covering a wide spectrum of topics with emphasis on current industry challenges.
Biopharmaceutical Development and Production Week
25 February – 1 March 2013 in Huntington Beach, CA:
IBC’s Biopharmaceutical Development and Production Week provides updates on current and emerging
methods
to improve your bioproduction capabilities. This event delivers strategies to help you overcome the challenges and accelerate production of the biopharmaceutical industry’s most exciting new
molecules
.
“…provides a fluid representation of the changing landscape of our industry, allowing networking and topical discussion around our industry’s current state of the art and the relevant challenges of the day.” —Bryan D. Monroe (Life Technologies)
Flexible Facilities
2–4 Apri...
A Coronavirus — like severe acute respiratory syndrome (SARS) — is back in the headlines. On returning from a trip to Saudi Arabia in summer 2012, a Qatari national was struck down by a mystery respiratory illness. Because of inadequate diagnostic capabilities, the patient was transferred from Qatar to London for intensive-care treatment and diagnosis. The UK Health Protection Agency (HPA) confirmed infection with the same Coronavirus strain discovered by a Dutch team following the death of a Saudi national earlier in 2012. Further investigations have confirmed nine cases by laboratory analysis, with five fatalities, all originating in Jordan, Qatar, and Saudi Arabia between April and October 2012 (
1
).
SARS first became known to the world in late 2002 and quickly spread from south China through Asia and North America. Ultimately it affected >8,000 people, with ∼800 related deaths. Are health authorities now better prepared to deal with the emergence and diagnosis of new infectious diseases? The answer i...
