Pharmacology & Pharmacy, 2010, 1, 33-38
10.4236/pp.2010.11005 Published Online July 2010 (http://www.SciRP.org/journal/pp)
Copyright © 2010 SciRes. PP
33
New Design of Biopharmaceuticals through the
Use of Microalgae Addressed to Global
Geopolitical and Economic Changes. Are You
Ready for New Development in Biopharma?
Armen B. Avagyan
Re sea r c h & I n du st ry Ce n te r o f Photosynthesizing Or g an i s ms, F ee d Additives an d Ph ysiologically A ct iv e Co mp o un d s, Yerevan, Armenia.
Email: armin.av@hotmail.com
Received May 6th, 2010; accepted July 8th, 2010.
ABSTRACT
The Biopharma industry is enduring sweeping change in response to the financial crisis, but one aspect of the industry
that emerged relatively unscathed and that perhaps has directly benefited from the crisis is new revolutionary innova-
tion solution. Identifying opportunities in the next wave of technologies for Biopharma, along with other policy initia-
tives including financial crisis actions and climate policy, will affect on manufacturing biopharmaceutical products
today and in the future in cost effective manner, and will be our adequate answer addressing to global geopolitical,
economic and climate changes. It also und erscores the search for new approach, evidenced by trends around new for-
mulations to serve lower income patients. Microalgae biomass comes in many strains, and can be used by means of
variety product developments. In the last years the key task of our R & D was to find a solution for these tasks. The bio-
fuel market development dynamics include significant opportunity of microalgae raw material and microalgae proc-
essing biomass rest of biodiesel manufacturing for Biopharma global growth in cost effective manner. Second new
source of microalgae raw material for Biopharma include microalgae production through waste and wastewater
cleaning. This should pro vide the opportunity to see the future in a new vision, where technology can serve as a revela-
tion of the truth and where every endeavor is governed by reflection on and appreciation of the environment and thus
leading to resolution of global tasks facing the world community and inclusion of microalgae in production and bio
cycles open new cost effective ways for Biopharma companies and conservation of nature. A truly coherent microalgae
raw material and Biopharma production policy has to find ways to bring these two traces closer for cost effective
manufacturing, well being Biopharma economy and human health.
Keywords: Biopharma Development, Microalgae, Biofuel , Wastewater Cleani ng
1. Biopharma Market Development Policy
Biopharma development progressive policy can be cate-
gorized in many different ways. The Obama administra-
tions policies will affect the pharmacy industry going
forward [1,2]. One is cost-containment track. This track
has been built by legislative initiatives and key health-
care post nominations. The second is science-innovation
track, powered by the economic stimulus package ($ 10
billions for National Institute of Health and with pres-
timuus budget of more than $ 30 billions) [2]. Those 10
years also witnessed the first clear signs emerging of a
fundamental shift in the balance of economic and politi-
cal power from West to East, as the big emerging mar-
kets of Asia—an d beyond—began to ch allenge the long-
standing dominance of the U.S. and Europe. The issues
identified, reimbursement challenges in emerging mar-
kets dominate the list, with potentially game-changing
initiatives underway in Korea and China, and also in Ja-
pan [3]. Growth in the emerging markets is predicted
11-14% from 2008 to 2013. However, at last years, the
trend has been for large pharmaceutical manufacturers to
shed their consumer health divisions to narrow their
business focus to a highly profitable core. As a result the
last decade sales of biopharmaceutical products have
grown dramatically and relatively steadily from less than
$ 25 billion in 2000 to n early $ 90 billion in 2008 . At the
same time, technology has created an environment for
New Design of Biopharmaceuticals through the U se of Microalgae Addressed to Global Geopolitical and
Economic Changes. Are You Ready for New Development in Biopharma?
Copyright © 2010 SciRes. PP
34
tremendous short- and long-term currency volatility as
legions of investors can pile into or out of a currency in
milliseconds. While the forces sharping the world of
business are much the same–technology, population
changes, natural resources, regulation, environmental
concerns, political movies and social pressure–the effects
of these forces are a constant state of flux, as companies
learn new ways to interact with their customers. Today,
process innovation is becoming as important as product
innovation, because without finding better ways to pro-
mote access to needed medicines, industry’s best scien-
tific assets can never be fully leveraged to support real
gains in health outcomes. The determination to find a
solution may have been fueled in part by desperation—
and the fact that the world had just been dealt a sobering
slap in the face by the financial crisis. It also underscores
the search for new approach, evidenced by trends around
new formulations to serve lower income patients. What
will happen to the innovative category of drugs and raw
materials that have been eligible for sa le a t a competitive
low price? What is certain is that the shotgun approach
belongs to the past, while precision focus and selectivity
are taking hold across the industry. But many leading
pharma manufacturers have been shaken out of their in-
ertia when it comes to the existing R & D focus and the
sales of biopharmaceutical product faced with a triple
hammy of declining R & D productivity and increasing
pricing forward looking companies must embracing new
outsourcing strategies to achieve and maintain profitable
growth [2,4,5]. Technology must been key factor in new
changes. Nowadays we need a series of new R & D solu-
tions for Biopharma, which may be well advised to view
portfolios of R & D-based manufacturers from a new
perspective. The world could actually enhance economic
output and welfare by pursuing a path of mitigation cost
through profitable innovation. This creates both new op-
portunities and new headaches. Brain storming is a useful
way of generating radical solutions to problems and its
effective strategies is prime the pump and improve abil-
ity to generate bright ideas. It is particularly useful when
you want to break out of stale, established patterns of
thinking, so that you can develop new ways of looking at
things. This article present situtional analyses and our
approch in the framework of our concept addressed to
global sustainable development through including micro-
algae and its biomass in Production (such as wastewater
treatment and biofuel manufacturing) and Bio Cycles
(such as biopharmaceuticals, feed, perfumery etc. pro-
ductions) [6,7].
2. Biopharma Project-Thinking to the Future
The Biopharma industry is enduring sweeping change in
response to the financial crisis, but one aspect of the in-
dustry that emerged relatively unscathed and that perhaps
has directly benefited from the crisis is new revolution-
ary innovation solution. It is already clear that the
world’s infrastructure will change dramatically in the
decade ahead as a result of trends already in place. In
analyzing supply and demand for bio-manufacturing ca-
pacity, we able to iden tify and track industry-wide trend s
in production of biopharmaceutical products and to fore-
cast future directions for this highly dynamic field. The
level of economic development directions and the policy
choices are important factors determining the nature of
the problems faced Biopharma and the ways in which
they are solving. Despite several decades of experience
in monitoring bioreactors and refining cell culture opera-
tions, the production of safe, pure and potent biologics
remains a tricly business [1-5].
Rising energy and transportation costs and impending
rules on carbon emission are promoting companies to
reassess their sourcing strategies. The last year ended
with United Nations conference of Copenhagen in De-
cember, with many hoping for a Kyoto-style consensus
to shape globally environmental policy. The countries
involved failed come to a b inding agreement, but instead
signed the Copenhagen Accord, which pledged $ 30 bil-
lion a year to a fund for poor countries to adapt to cli-
mate change from 2010-2012 , an d $ 100 billio n a year by
2020. The fuel economy improvements and introduction
of bioetanol and biodisiel add more opportunities for
Biopharma developing. Biofuel manufacturing is ex-
pected to be a new rapidly growing global market for
algae biomass and increase volume of its products [8].
Our vision infers suggests that algae have emerged as
one of the most promising sources especially for Bio-
pharma development. The validity of this approach in-
creases and confirms in the face of Biofuels Digest up-
dated Advanced Biofuels tracking database, based on
announced projects and updated company guidance
tracking 56 companies with advanc ed biofuels proj ects in
13 countries [9]. According this database algal biodiesel
volume projected to reach 421 million gallons per year in
2013. The biofuel market development dynamics include
significant opportunity of microalgae raw material for
Biopharma global growth in cost effective manner and
new technological innovation leading to the ability to
develop a roll-out pl at f orm.
Second new source of microalgae raw material for
Biopharma. The EU Landfill Directive has forced waste
management policies across the member states of the EU
to reduce the amount of waste sent for disposal in landfill.
The directive requires that progressively increasing
quantities of biologically active waste are diverted away
from landfill. May be the criteria of the Landfill Direc-
tive can become the main drivers for the use microalgae
aimed to cleaning their wastewaters in Biopharma? It is
New Design of Biopharmaceuticals through the U se of Microalgae Addressed to Global Geopolitical and
Economic Changes. Are You Ready for New Development in Biopharma?
Copyright © 2010 SciRes. PP
35
known that the biological method is considered the most
effective and economically efficient method for the puri-
fication of industrial wastewater by using of the microbio-
logical active slime or alga. However, bacteria of the
active slime have low stability to high concentration of
organic and mineral components, thus considering big
water flow volumes [7,10]. This method also requires
further destruction of superfluous quantity of active sli me,
which contains also pathogenic microorganisms. Micro-
algae have higher stability, which enables working in
more concentrated and toxic environments. Chlorella
actively utilizes mineral elements, spirits, sugar, and
amino acids and as compared with active slime enables
higher purification rate (up to 96-98% for organic and
80% for mineral components, accordingly). In the last
years the key task of our R & D was to find a solution for
this problem, because microalgae possess higher stability,
which enables their use in more concentrated and toxic
environments, and our Center strategy believes also that
the cost saving of raw material with the use of waste-
waters through their biological cleaning will help raise
the availability of microalgae biomass for biofuel, bio-
pharmaceuticals, food, agriculture producers, thus lead-
ing to resolution of global tasks facing the world com-
munity. The Center carried out researchers for develop-
ment technologies of microalgae cultivation in some
wastewaters of industrial plants [8]. As a result the Cen-
ter developed a cost-effective technology applying new
innovative approaches in various stages of microalgae
production and this technology for microalgae produc-
tion may be applied all around the world. The exhaust
steam and effluent gas (including greenhouse emissions)
may be used for heating microalgae suspension in bio-
technological pools so the biomass manufacture not will
be available year-around. Simultaneously the high norms
of wastewater purification from organic and mineral
compounds were achieved and in parallel to this it was
accompanied by sharp reduction of the bacteria contents
in strongly microbiological infected biotechnilogical
wastewater. Therefore receiving microalgae biomass by
waste and wastewater cleaning and inclusion it in bio
cycles open new cost effective way for Biopharma com-
panies and conservation of nature. This should provide
the opportunity to see the future in a new vision, where
technology can serve as a revelation of the truth and
where every endeavor is governed by reflection on and
appreciation of the environment and thus leading to reso-
lution of global tasks facing the world community. Thus,
manufacturing microalgae through the use and purifica-
tion of wastewaters, as well as microalgae processing
biomass rest of biodiesel manufacturing must be ways
for manufacturing biopharmaceutical in cost effective
manner and an additional source of profit.
3. Which Value Can Obtain Biopharma
from Microalgae Biomass?
Microalgae are a diverse group of microscopic plants
with the wide range of physiological and biochemical
characteristics and contain up to 50-70% protein (up to
50% in meat, and 15-17% in wheat), 30% lipids, over
40% glycerol, up to 8-14% carotene and a fairly high
concentration of vitamins B1, B2, B3, B6, B12, E, K, D,
etc., compared with other plants or animals [11]. More-
over, microalgae are meant to be an important raw mate-
rial for amino acids, vitamins and productions of other
pharmateuticals. The cultivation of microalgae is known
to be the most profitable business in the biotechnological
industry. It is a wasteless, ecologically pure, energy and
resource saving process. They are also harvested very
quickly; dramatically speeding up production process
with small water consumption. Additionally algae can
adsorb up to 450 tons of CO2 per acre when grown
commercially.
The potential of microalgae biomass for big Pharma
practical uses is certainly great. The first use of microal-
gae by humans dates back 2000 years to the Chinese,
who used Nostoc to survive during famine. At present
around 110 commercial producers of microalgae are in
the Asia-Pacific region, with annual production capac-
ity ranging from 3 to 500 tones [12]. The commercially
cultivated microalgae include Chlorella, Spirulina, Du-
naliella, Nannochloris, Nitzschia, Crypthecodinium, Sc-
hizochytrium, Tetraselmis, Skeletonema etc. The market
survey shows that being developed in the last 20-30 years,
the microalgae production volume increased excessively
[10]. In fact, the former USSR was the first to become a
large scale manufacturing of microalgae, in the frame-
work of producing high quality feed additives [11]. In
1980 more than 500 Chlorella manufacturings were in
farms of Uzbekistan (mainly for sheep, adding 1 liter
microalgae suspension in the daily diet of sheep in-
creased their weight gain by 15-20%) as well as ad-
diitional facielties in other Soviet republics. Chlorella
powder raised the poultry the average daily weight by
13%, egg-laying quality by 10-30% (paste–by 26-30%),
quantity of vitamins in liver increased 2-3 times and rate
of poultry mortality decreased up to 7-23%. Chlorella
protein digestibility reached up to 85 percent. The aver-
age daily weight gain of pigs increased twice due to the
use of Chlorella paste. Chlorella protein digestibility for
pigs was 52-72%. In our Industrial test ccombined feed
with 1% of Chlorella powder (produced through cleaning
of biotechnological wastewater of crystallic lysine) used
on 25200 species of fishes (average weight-12.7 g). Dur-
ing the first 20 days the daily average weight gain in-
creased by 20% (0.97 g in tested and 0.73 g in the control
group), and the mortality reduced by 48% (0.77% and
New Design of Biopharmaceuticals through the U se of Microalgae Addressed to Global Geopolitical and
Economic Changes. Are You Ready for New Development in Biopharma?
Copyright © 2010 SciRes. PP
36
1.25%, respectively) [11]. However, the disintegration of
the USSR has caused interruption of all these manufac-
turing.
Second-generation microalgae large scale manufac-
turing volume sharply increased due to significant influ-
ence of food, high-quality perfumery additives related
industry development (the U.S. (Sun Wellness Inc.,
Cyanotech.Corp., etc), Japan (Yaeyama Factory, etc.).
Most of the commercially produced algal biomass is be-
ing marketed as health food, in the forms of tablets and
capsules. Algae and their extract are also included in
noodles, wine, beverages, breakfast cereals and cosme-
tics. So, currently over 75% of pharmaceutical product
development is generated by the food suppliment pro-
duction comprising also microalgae. About 61% of
Americans (spending $ 6 billion yearly) and 43% of
Europeans use food additives.
4. Which Role Can Microalgae and its
Processing Raw Materials of th e B iofu el
Production and Wastewater Cleaning
Take in the Production Pa tterns?
Microalgae biomass comes in many strains, and can be
used by means of variety product developments. Blue-green
algae are a group of prokaryotes which history goes back
to 2700 million years. Blue-green cyanophytes are not
true algae. They have no nucleus, the structure that en-
closes the DNA, and no chloroplast, the structure that
encloses the photosynthetic membranes, the structures
that are evident in photosynthetic true algae. It was set at
a level considered to be safe for human consumption. In
China, Taiwan and Japan, several cyanophytes are served
as a side dish and are considered a delicacy [12]. The
very potent toxins produced by many solitary, filamen-
tous or colonial aquatic cyanophytes, are responsible for
an increasing number of water-related po isonings of both
wildlife and people [7]. The World Health Organization
has a limit on the toxin Microcystin at one part per bil-
lion (ppb). In 1998, the U. S. Environmental Protection
Agency (EPA) included freshwater cyanobacteria and
their toxins on the first Candidate Contaminant List
(CCL) (Federal Register 1998). For this reason, the use
of cyanophytes blue-green must be allow only from large
producer- companies with good developed toxin control.
American Cyanotech. Corp. and Russian Convercia
produce vitamin-mineral complex (pills of Spirullina) as
a food additive and milk substitute [9]. It effectively re-
moves slag’s (heavy metals, radio nucleotides and leu-
kocytes) from organism, reduces influence of irradiation,
sugar and cholesterol in blood, cardiovascular diseases as
well as increases immunity and improves skin condition.
It is also useful for liver diseases, arthritis, asthenia and
insomnia, regulates normal pregnancy and lactation and
prevents accumulation of excessive weight. Natural
products of microalgae are leading sources of novel
molecules that have been used in the pharmaceutical and
nutraceutical industries since their inception. So, product
list of Cyanotech. Corp. included also natural astaxanthin
BioAstin for humans, produced from Spirullin a, which
reviewed by the U.S. Food and Drug Administration and
have up to 550 times the antioxidant activity of vitamin E
and 10 times the antioxidant activity of beta-carotene,
and surpasses many of the antioxidant benefits of vitamin
C and other carotenoids [13].
Green algae evolved from prokaryotes between 2500
and 1000 million years ago. Chlorella is a microscopic,
green, single cell and has not toxins. During 12 hours
Chlorella cell provides fourfold reproduction of cells in
optimum conditions. Compared to the traditional plants,
the water consumption of manufacturing is over 10 times
as low. The biomass yield per sq. are 5 times higher.
Other main Chlorella biological priorities are as follow-
ing [11]:
1) High concentration of protein (50%) and amino ac-
ids,
2) High concentration of chlorophyll (5-10 times as
much, compared to Spirullina or Lucerne), the molecule
of which is identical to hemoglobin molecule structure.
Therefore, if getting in blood flow, it sates blood with
oxygen and is transformed to hemoglobin. The chloro-
phyll is an effective means for the treatment of anemia, a
pancreatitis, skin ulcer, diabetes, recovery of peristalsis
affect and normalization of digestive juice excretion. It
owns anticancer, anti-inflammatory, antisep tic and regen-
erating properties,
3) Unique properties of a cell wall which consists of
three layers (the largest-a middle part consists of cellu-
lose, and the outer layer is formed of polymeric carotene
which is capable of adsorbing toxic elements and re-
moving them from organisms),
4) High contents of vitamins, especially, pro-vitamin
A–carotene, which not only plays an important role dur-
ing the growth process, but destructs cancer cells as well
in initial stages and improves the generation of macro-
bacteriophage in immune system,
5) Ability to intensively synthesize high concentration
of nucleonic acids with a combination of high contents of
fibers, peptides, amino acids, other vitamins, sugars and
trace elements. This not only promotes super fast repro-
duction of Chlorella, but as a growth factor also provides
favorable conditions for the use of Chlorella in other
organisms.
6) Chlorella has also organic acids, which prevent the
growth of pathogenic microorganisms in wastewater and
feed. While antibiotics were proven to be effective in
improving agricultural production, their use came under
pressure as an increasing number of consumers feared
New Design of Biopharmaceuticals through the U se of Microalgae Addressed to Global Geopolitical and
Economic Changes. Are You Ready for New Development in Biopharma?
Copyright © 2010 SciRes. PP
37
that their inclusion in animal feed rations would lead to
antibiotic resistant bacteria that are pathogenic to humans.
In 2005, the EU removed the last antibiotic growth pro-
moters from pig and poultry diets. As consensus begins
to develop among the scientific community on this sub-
ject, a few approaches stand out in terms of efficacy,
technological and economical feasibility, particularly in
terms of organic acids and the use of essential or botani-
cal oils [7,8]. Organic acids provide a natural alternative,
reducing production of toxic components by bacteria and
causing a change in the morphology of the intestinal wall
that reduces colonization of pathogens, thus preventing
damage to the epithelial cells. Anions of organic acids
deactivate the RNA transferase enzyme, which damage
the nucleic acid multiplication process and eventually
result in death of the organisms. But the manufacturing
of organic acids and essential oils for the feed industry
are potentially a source of other problems: corrosion,
worker safety, handling, vitamin stability in pre-mixes,
environmental concerns, and the stability of products
[8,11]. With all this in mind, the use of microalgae
Chlorella could become the best solution, since microal-
gae contain natural organic acids (hexadecatetraenoic (up
to 7-8% of total fatty acid quantity) and octadecatet-
raenoic acids, as well as oxy, aldehyde and keto acids,
which increase spectrum of antibacterial action) that re-
duce colonization of pathogens. Therefore, thanks to this
feature Chlorella is also used for feed conservation, and
the reduction of microbiological pollution of wastewa-
ters.
Chlorella studies have sh own the plant’s cells are pro-
active in stimulating T-cells, and largely improving the
immune system’s ability to ward off the formation of
diseases like cancer, hypoglycemia, and bacteria [14].
Chlorella’s high concentration of chlorophyll has been
cited to eliminate halitosis in a matter of just days and
after reversing constipation, Chlorella can improve the
stink of heavily accented stools.
In the end of 1990 in former USSR clinical tests ex-
amined Lipid concentrate of Chlorella (for the treatment
of colitis, cervical erosion and burn) and Chlorella hy-
drolysate (for the improvement of working capasity).
According to all-Union State Standards of the CIS coun-
tries this products can use for shampoos, creams, tooth
pastes, lotions etc. as bioactive additive.
The yellow microalgae can be used as sourse of ara-
chidonic eicosapentaenoic acids aimed to manufacturing
of drugs.
The growing worldwide market value of carotenoids is
projected to reach over US $ 1,000 million and there the
use of microalgae open possibility aimed to reduction in
production costs [15]. The Israel and Australia compa-
nies specialized in carotene production from unicellular
green Dunaliella microalgae (up to 8-14% carotene, over
40% of glycerol).
Omega-3-fatty aids can not be constructed within our
bodies. Therefore they must be obtained from the diet,
making outside source. DHA is found at low levels in
fish and at high levels in certain microalgae oils. Con-
centrated omega-3 DHA dietary supplements made from
microalgae oils or extracted from fish oils currently are
the best way to get medical dosages of DHA at levels
above 1 gram daily [16]. They extracted from algae with
organic solvents from protein while the fish oil is pressed
out of cooked fish mass during fishmeal production. In
California, BioCentric Energy Holdings announced the
commercialization of its closed-loop Photo-Bioreactor
system for the mass production and subsequent comer-
cialization of algae products for Omega-3 (EPA) oil and
algal biomass [17].
Recitals of the experience gained on microalgae use
may continue, but the above discussion demonstrates an
increasing need to the use of microalgae in Biopharma.
Identifying opportunities in the next wave of technolo-
gies for Biopharma, along with other policy initiatives
including financial crisis actions and climate policy, will
affect on manufacturing biopharmaceutical products to-
day and in the future in cost effective manner, and will
be our adequate an swer addressing to global g eopolitical,
economic and climate changes. A truly coherent micro-
algae raw material and Biopharma production policy has
to find ways to bring these two traces closer for cost ef-
fective manufacturing, well being Biopharma economy
and human health. Further isolation and identification of
novel metabolites from microalgae will help to feed the
pipeline of the biopharmaceutical industries for the
development of new therapeutic agents, but also open a
door for nutraceutical and functional food industries.
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Economic Changes. Are You Ready for New Development in Biopharma?
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