FOCUS ON...

PRODUCTION

Bioreactor Design for

Adherent Cell Culture
The Bolt-On Bioreactor Project, Part 4: Process Economics
by Marcos Simn

22 BioProcess International

13(8)

S eptember 2015

The Open Design Initiative

50

Capital Expenditures

Replacing an established
technology is especially cumbersome
for biopharmaceutical production
because the process- and productquality influence of newly introduced
technologies are major concerns. That
is not only for bioprocessors
themselves, but also for regulatory
authorities who will want detailed
reporting on every minor modification
introduced and the effects of such
changes on product quality.
Thus, even if a novel production
technology is more efficient than an
established one, substitution is not an
obvious decision. It requires minute
analysis from different viewpoints.
Process economics are vitally
important to these decisions. Such
considerations explain the

Volumetric Productivity

WWW.PHOTOS.COM

75

Cost of Production Process

100

Cost of Single-Use Device

The BoB team has its own views on

addressing the four challenges that
must be met in designing a future
standard solution for adherent cell
culture. Market opinion is most
important, however. So the team has
conducted a series of surveys to provide
insights on design features that would
best suit market needs. A public survey
conducted in September and October of
2014 asked about the relevance of
various cost parameters to overcome
Challenge #4. Results are shown here.

Respondents (%)

he Bolt-on Bioreactor (BoB)

project is an independent
initiative developing and
commercializing a bioreactor
for efficient, automated culture of
adherent cells for biopharmaceutical
applications (1). After conducting
thorough research on available culture
systems for adherent cells, the BoB
team believes that a successful
alternative to existing devices must
solve four major challenges: volumetric
productivity (2), process automation
(3), containment and sterility (4), and
process economics. This month
concludes a four-part series addressing
each of those challenges while
describing design features
incorporated into the BoB system to
overcome them.
Determining the maximum capacity
of a production plant is a crucial
decision with extreme impact on capital
expenditure and both fixed and variable
manufacturing costs. A
biopharmaceutical companys
competitive position and market
performance can depend on making the
right choice early on. It becomes more
complex when considering the
enormous differences in requirements
for space and utilities among production
technologies for a given maximum
capacity. Depending on design features,
different technologies can be
accommodated in the same production
plant, and obsolete technologies can be
replaced with more efficient ones.
Otherwise, a new plant must be
designed, built, and commissioned
before a novel production technology
can be implemented.

25

homogeneity of the answers to our

survey on the relevance of different
cost parameters (see the Open Design
Initiative box above).
For this analysis, I include in my
calculations only costs and expenses
that are affected by cell culture
technology. I exclude other costs
related to production but not so
affected. Estimating the full cost of an
overall production process or total
capital expenditure is beyond the
scope of this study. The analyzed

Figure 1: Operating costs and capital expenditure (CapEx) comparison at 1,000-m2 production scale; broken lines indicate the maximum price of a BoB
single-use culture chamber in $US/cm2 (left) and maximum investment in control units in US$ (right) that make a BoB system more economically
advantageous to users than indicated technologies at 1,000-m2 production scale.

Operating Costs ($/cm2)

0.20

Plate
Stack

Roller
Bottle

Microcarrier

0.10
BoB
0.00

300

Roller
Bottle

200
Microcarrier
100

process spans the initiation of cell

culture to total colonization of all
available culture surface with a further
15-day maintenance culture for
continued supernatant harvesting.
Im comparing three existing
technologies with the BoB concept:
plate stacks, roller bottles, and
microcarriers. Cost information comes
from different sources. Some numbers
are reported in technical literature,
others come from my own professional
experience, some data come from
publicly available sources, and others
are estimations or calculations based
on my best knowledge. Costs were
converted into US dollars at
concurrent exchange rates to this
report.
For clarity, I have divided
manufacturing costs into variable and
fixed categories. Major sources for
publicly available prices include www.
coleparmer.com, www.us.vwr.com/
store, www.sigmaaldrich.com, www.
amazon.com, www.us.vwr.com, and
www.gelifesciences.com (data
retrieved in September 2014).

Variable Manufacturing Costs

This category includes all costs that

vary proportionally to the number of
units produced. Here, the production
unit is the square centimeter of celladhesion surface. The adequacy of
different surfaces for culturing
adherent cells is explored in a previous
installment of this series (2).
Raw Materials: This subcategory
includes single-use materials that are
used and consumed during
production.
24 BioProcess International

Capital Expenditure ($)

400

0.30

13(8)

Cell Culture Device: Prices for

different devices come from list prices
where available and otherwise from
those reported by different
organizations and available online. To
calculate total expenditures, I
considered the cost of all culture
devices used in a model process. For
example, consider that the target
production area for a given batch is
1,000 cm 2, and it starts with a
100cm 2 T-flask culture, which is
subcultured into three T-175 flasks
(525 cm 2), with a final passage in six
T-175 flasks (1,050 cm 2). Prices for
each T-100 and T-175 flask are
respectively $6.10 and $7.60, so the
total cost of cell culture devices used
in this process is $74.50: (1 $6.10) +
(3 $7.60) + (6 $7.60). During the
final 15-day stage, no further
consumption of such devices is
necessary.
While analyzing the cost of
different available culture devices, I
found a slight reduction in cost per
square centimeter for each vendor and
product as device size increases. That
correlation disappears when several
different vendors and products are
included in the analysis. So I
calculated average costs for each
technology: $0.017/cm 2 for roller
bottles, $0.061/cm 2 for plate stacks,
and $0.044/cm 2 for microcarriers.
Each cell culture device represents an
individual purchase unit, with 1 g
being the basic unit for microcarriers.
I have assumed all cell culture
processes to begin with a 150-cm 2
culture, with a surface-dilution factor
of five for every subpassage.

S eptember 2015

Plate
Stack
BoB

Special Accessories: Some cell

culture devices require special
accessories for operation (e.g., plate
stacks need special accessories for
filling and harvesting). These
accessories may include venting filters,
caps, and tubing (5). Microcarriers
require culture bags for use. And the
cost of those bags per liter varies
depending on their volume, which in
turn varies depending on the number
of microcarriers needed to provide a
desired culture area. I estimate special
accessories to cost $0.00 per roller
bottle, $114.80 per plate stack, and
$114.80 per BoB unit. In the case of
microcarriers, the cost per device
varies with the number of devices and
is estimated at $228.70x0.92, where x
is the number of devices.
Culture Medium: The volume of
culture medium used in a given
process is proportional to the volume
used per square centimeter of cellattachment area, total cellattachment area, process duration,
and medium replacement rate (which
in turn is proportional to the
metabolic activity of the cell
population). Here I assume complete
medium replacement with every cell
doubling (both medium replacement
and cell doubling having equal rates).
And for convenience, I assume that
attachment area doubles at the same
rate. With a starting culture area of
150 cm 2 , attachment area in a given
subculture step (for the purpose of
estimating culture medium use) is
calculated as follows: 150 2 n =
attachment area, where n is the total
number of cell doublings that have

Direct Labor: This subcategory

includes costs of employees working on
production-related activities. To
estimate labor cost, I calculated the
number of hours necessary to perform
necessary production and quality control
tasks and multiplied by $30/hour.
Production Labor: Different steps in
a production process require different
amounts of time from laboratory
technicians and other employees.
Necessary labor differs according to
the number of operations required
from employees and the number of
devices involved. I calculated these
costs for the cell-expansion stage to be
$19.50/device for roller bottles,
$45.00/device for plate stacks,
$127.50/BoB unit, and $60.72x24 for
microcarriers, where x is the number
of devices. I calculated the production
labor costs for the additional 15-day
supernatant harvesting stage to be
$68.25/roller bottle and $142.50/plate

stack and $30/day for microcarriers

and a BoB system, respectively.
Quality Control: In-process analysis
is the established method for
bioprocess quality control. Associated
labor costs are driven mainly by the
overall number of culture devices used
for discontinuous processes and by a
daily control for continuous processes.
I calculated these costs in the cellexpansion stage to be $2.4/roller bottle
and $7.5/plate stack and $60/day for
microcarriers and a BoB system. For
the additional 15-day supernatant
harvesting stage, I estimated costs at
$18.00/roller bottle and $56.25/plate
stacks and $30/day for microcarriers
and a BoB system.
Inventory Shrinkage: In my present
analysis, I considered inventory losses
to depend exclusively on batchcontamination events. Airborne
particles and aerosols generated during
culture manipulations represent the

1.0
0.5
0.0

0.5
1.0

0.1

1.0

10.0 100 1,000 10,000

Expenditure ($)

Figure 2: Maximum allowed prices for a BoB system (left) maximum price of the culture
chamber in $US/cm2 and (right) maximum investment in control units in $US make the system
more economically advantageous to users than other technologies at different (logarithmic)
production scales (Table 1).

Price ($/cm2)

taken place at the time of the

subculture.
For example, with a cell population
dividing every 36 hours in a
discontinuous process (e.g., in roller
bottles), total medium replacement will
take place every 36 hours, and the
amount of culture medium replaced will
be 0.25 mL/cm2 of culture area in use
at the moment of medium replacement.
For continuous processes (as in a Bolton Bioreactor system), however,
medium replacement takes place
continuously. The overall replacement
rate is the same, with an important
difference in medium consumption at
the last medium replacement step.
Discontinuous processes must waste
culture medium at that point, whereas
continuous processes adjust to the
required volume. So for the final 15-day
supernatant harvesting stage, I
calculated culture media consumption at
a rate of 0.25 mL/cm2 every second day.
The numbers used herein are
representative of real numbers but may
vary considerably for different processes.
Although production scale influences
the cost of culture media, sourcing
policies will truly determine the media
cost for a given company. So I have
chosen to set a fixed cost per liter that is
independent of scale: $8/L (6).
Process Solutions: Although
different culture processes need
different compositions for nonmedia
process solutions (e.g., washing
buffers, equilibration buffers, and cell
harvest solutions) or do not need some
of them at all, it is safe to assume that
process solutions will be used during
subculturing. Thus I have considered
the volume of such solutions to be
proportional to the number of
subpassages (every 2.3 cell doublings)
and the total attachment area
(0.25mL/cm 2) for each subpassage,
with no further consumption during
the final 15-day supernatant
harvesting stage. I estimate the
process solution cost at $8/L.
Other Consumables: Some common
laboratory materials (e.g., pipette tips,
syringes, gloves, tubes, and glassware)
are used proportionally to the number
of devices used in a bioprocess, no
matter their type or volumetric area. I
set this cost arbitrarily at $1/device.

2,500
2,000
1,500
1,000
500
0

Roller
Bottle
Microcarrier
0.1

Production Scale (m2)

Plate
Stack

1.0 10.0 100 1,000 10,000

Production Scale (m2)

Table 1: Maximum allowed prices for a BoB system (top) maximum price of the culture chamber
in $US/cm2 and (bottom) maximum investment in control units in $US make the system more
economically advantageous than indicated culture technologies at different production scales
(Figure 2).
Production Scale (m2)

Plate Stack

Microcarrier

0.10

Roller Bottle
0.955

0.558

0.783

1.00

0.025

0.165

0.246

10.00

0.054

0.151

0.149

100.00

0.087

0.169

0.147

1,000.00

0.106

0.209

0.152

10,000.00

0.103

0.214

0.145

Roller Bottle

Plate Stack

Microcarrier

Production Scale (m2)

0.1

6,652

5,632

8,351

1.0

9,075

7,355

15,919

10.0

18,267

9,989

30,424

100.0

56,116

15,732

58,828

1,000.0

293,176

35,414

120,783

10,000.0

2,260,807

174,755

320,789

S eptember 2015

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BioProcess International 25

greatest source of contamination (7). So

for simplicity within the scope of this
study, I assume exposure of the interior
of open culture vessels to be the
contamination source. To estimate the
probability of a batch being
contaminated and discarded, I take as a
starting point the value of mycoplasmacontaminated cultures provided by
Uphoff and Drexler (8): 1030%.
Now I assume an average of 0.2 as
the probability of a culture being
contaminated in regular research
laboratories, then cut that value by half
for industrial laboratories for an average
of 0.1. I also assume that number to
come from an average 15-day culture
starting from single-use T flasks,
moving through two T flasks on the
third day and four T flasks on the fifth
day. Opening every T flask twice every
second day adds up to 58 openclose
cycles. Thus, the probability of a batch
contamination after 58 openclose
cycles is 0.1, and the probability of no
batch contamination is 0.9. Assuming a
contamination in any openclose cycle
is an independent event, 0.9 = Pnc58,
and Pnc = 0.998, where Pnc is the
probability of a culture not being
contaminated for each individual open
close cycle. And the probability of a
batch being contaminated is
P = 1 0.998cycles, with cycles being the
total number of openclose or connect
disconnect cycles (twice the number of
devices). To account for the fact that
some contamination events occur early
in a process and some occur when it is
nearly finished, I estimate the cost of a
discarded batch to be 25% the cost of a
produced batch. With inventory loss
calculated as the probability of a batch
being contaminated multiplied by the
cost of a discarded batch (1 0.9982x
C/4, where x is the total number of
devices used in the process and C is the
cost of the process, excluded inventory
shrinkage). Although far from exact,
such an approximation helps compare
inventory shrinkage costs due to
contamination.
Variable Overhead Costs: In this
subcategory, I include costs that
increase or decrease as production
increases or decreases but that cannot
be directly assigned to each production
unit.
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Indirect Labor: This accounts for

additional time used by employees in
activities such as sourcing, warehouse
handling, and waste management. This
additional time increases with the
number of devices handled. I estimate
an additional 5 minutes/device at an
estimated cost of $1.67/device for an
indirect labor cost of $20/hour.
Indirect Materials: The consumption
of some materials such as labels,
boxes, bags, and paper increases with
the number of devices used. An
additional dollar per used device is
deemed sufficient to account for this.
Solid-Waste Management: Biological
waste must be disposed of by
authorized waste management
contractors or by authorized processes
within a given company. This cost
increases with the volume and weight
of waste. So variable overhead cost for
solid-waste management is directly
proportional to the number of devices
used and their unitary volume and
weight. Bearing in mind a cost for
medical waste management of $0.08
1.36/kg (9), I estimate the cost for
solid-waste treatment to be $0.72/kg.
From publicly available data
provided by manufacturers, I
calculated an average weight of 0.19 g/
cm 2 for roller bottles, 0.62 g/cm 2 for
plate stacks, and 11 g/L of plastic bags
used with microcarrier culture (10 g
microcarriers account for 3,200 cm 2
and require 1-L bag volume).
Materials used for rolled-membrane
manufacturing are similar to those of
roller bottles, so I estimate the weight
for rolled-membrane devices (e.g., a
BoB system) to be $0.09 g/cm 2. Solidwaste cost estimates are $1.37/m 2 for
roller bottles, $4.46/m 2 for plate
stacks, $0.02/m 2 for microcarriers, and
$0.65/m 2 for a BoB system.
Liquid-Waste Management: As for
solid waste, this cost increases with
the volume of liquid waste. Bearing in
mind the cost for medical waste
management (9), I estimate the cost
for liquid-waste treatment at $0.72/L
of culture medium and process
solutions used.

Fixed Manufacturing Costs

Here I consider fixed manufacturing

overhead costs those directly

related to manufacturing and

assume that maximum capacity is
determined by batch size. For
example, in analyzing fixed
manufacturing costs for production of
adherent cells on 100,000 cm 2, I do
not include marketing or after-sales
costs. Production facilities are
assumed to be of necessary size for a
maximum capacity of 100,000 cm 2
with a given cell culture technology.
So beyond the minimum area needed
for efficient operations, the size of
premises will be larger for higher
maximum capacities.
To account for the reduction in cell
duplication time with continuous
processes (as compared with batch
processes) as a consequence of the
absence of cellular stress and
subculture operations (1012), Im
considering production time for
continuous processes to be 30% faster.
This is a conservative estimation
considering that doubling time
increases >50% in stressing
environments (13, 14) over
discontinuous processes. I estimate
cell-doubling time to be 36 hours for
discontinuous processes and 25 hours
for continuous processes, both starting
with the seeding step. With the
process duration defined as how long
it takes to colonize the batch area
starting from 150 cm 2 and with the
assigned doubling times I
calculated the fixed costs as follows.
Electrical Power Consumption: A
large portion of electricity expense in a
bioprocess facility is associated with the
heating, ventilation, and airconditioning (HVAC) system, with
consumption proportional to the
volume of a production plant. From a
starting value of 5,000 kWh/day for a
15,000-ft2 good manufacturing practice
(GMP) plant (15) and assuming an
average ceiling height of 3 m I
calculate an average 1.2 kWh power
consumption per cubic meter each day.
As of June 2014, the average US
electrical cost was 7.3 cent/kWh (16).
Indirect Labor: More cleaning,
maintenance, and validation
employees are needed for larger
facilities. The average number of
indirect employees in GMP plants
came from an online source (15).

Assuming that each employee works

1,700 hours/year at $20/hour in a
plant with an average 3-m ceiling
height gives in an indirect labor cost
of $0.24/day m3.

Depreciation and Amortization of

Classified Areas: This cost accounts for

depreciation of general manufacturing

equipment in classified areas. The
basic unit is $/day m3, with capital
expenditure calculated from published
data (15) for facilities with an average
3-m ceiling height. To calculate the
facility volume needed to operate with
each adherent-cell technology, I
ignored the minimum facility size
common to all four technologies and
calculated the additional volume
necessary in classified areas as twice
the volume needed for the maximum
number of devices operating
simultaneously. Doing so accounts for
device handling as well as area taken
up by the specialty manufacturing
equipment. This cost is calculated at
$0.20/day m3.
Depreciation and Amortization of
Nonclassified Areas: This is the

depreciation cost of nonclassified areas

(e.g., warehouses). Unitary cost is
estimated as 33% of the respective
value for classified areas, and
necessary space is calculated as twice
the total volume of devices used
throughout a process to account for
storing and handling space. This
calculation gives $0.07/day m3.
Depreciation and Amortization of
Specialty Manufacturing Equipment:

This cost covers only special equipment

associated with cell culture using a
given technology. Roller bottles need
rollers and CO2 incubators, for
example, and microcarriers need
bioreactors. The basic unit is $/day m3,
with capital expenditure calculated
from the cost of equipment necessary
to culture cells at each scale. Calculated
values for this cost are $2.77v 0.41 +
$4.48v0.78 for roller bottles, $1.661v +
$4.48v0.78 for plate stacks, and
$26.63v 0.72 for microcarriers (v is the
volume taken up by the respective cell
culture apparatus).

Capital Expenditure

Capital expenditure (CapEx)

investments in long-term operating
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S eptember 2015

assets is an important factor to

consider when evaluating production
technologies. Compare the volume of
classified area needed for operating
thousands of roller bottles with the size
of plant necessary to accommodate a
bioreactor. In addition, depreciation
and amortization costs analyzed above
depend directly on some investments
included in CapEx. For this analysis, I
considered only items that affect fixed
manufacturing costs.
General Production Facilities: This
includes premises and utilities
necessary for manufacturing but
excluding classified areas. (Given the
large investment share they represent,
they get their own section below.)
Expenditure is calculated at $370/m3.
Classified Production Premises:

This category includes premises and

utilities subject to special
environmental control according to
GMP guidelines. Expenditure is
calculated at $1,110/m3.
Production Equipment: Here I
consider only special equipment
needed for manufacturing with a
given technology. Other
manufacturing equipment are included
above. I calculate this capital
expenditure to be $10,100v 0.41 +
$16,357v 0.78 for roller bottles, $3,030
+ $16,357v 0.78 for plate stacks, and
$97,187v 0.72 for microcarriers (v is the
volume in cubic meters taken up by
the respective cell culture apparatus).

BoB Pricing Analysis

Typically, adherent cells are cultured

either to expand the cells themselves
(e.g., cell therapies) or to obtain a
biological product produced by them.
To take both applications into account,
I consider costs of fully colonizing the
maximum available culture area at
different production scales along with
the costs of maintaining the final
culture for 15 days afterward.
After computing all calculated data
for manufacturing costs and CapEx, I
calculated the maximum allowed price
for BoB culture chambers and
maximum allowed expenditure in BoB
control units that render the BoB
system economically advantageous for
customers. To do so, I compared the
cost per square centimeter of the

culture process and the CapEx at

different scales for different
technologies relative to the BoB system
when BoB control unit and culture
chamber price is $0.00. Figure 1
graphically represents this calculation
process. Table 1 lists values obtained
for the maximum allowed price of a
BoB culture chamber and maximum
allowed expenditure in BoB control
units for manufacturing costs and
CapEx equal to those of the other three
technologies at any of six production
scales. Figure 2 plots the results.
Those data suggest a maximum
price for BoB culture chambers and a
maximum investment in BoB control
units to make the system more
economically advantageous for users
than any of the other technologies at
different production scales. Any
selling price below those shown in
Table 1 and higher than the costs of
producing and commercializing the
BoB concept will render economic
benefit to both user and supplier.
By comparing the selling prices of
culture devices and production
equipment associated with three other
technologies, the BoB team concludes
that advantageous selling prices for
both user and supplier should be
feasible for BoB systems at any
production scale >1 m 2. Production
scales between 0.1 m 2 and 1 m 2 will
require a usage-intensity analysis to
determine the effect of CapEx on the
overall costs of such production
processes. The results herein provide a
solution to the fourth challenge faced
by the BoB team: to develop a system
that will be economically feasible to
provide economic benefits both to its
vendor and customers.

Reference

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Cell Culture, 2014; www.boltonbioreactor.com.
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Marcos Simn, PhD, is founder of the Bolton Bioreactor Project, Technology Park,
Miramon 182, 20009 San Sebastian, Spain;
[email protected];
www.boltonbioreactor.com.
For electronic or printed reprints, contact
Rhonda Brown of Foster Printing Service,
[email protected], 1-866-879-9144
x194. Download personal-useonly PDFs
online at www.bioprocessintl.com.

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World class academics and senior industrial experts will lead delegates through a series of lectures
supported by industrially relevant workshops and case studies and explore best practises. In addition there
will be excellent networking opportunities with your peers, sector leaders and subject matter experts to
discuss challenges, best practises and the future analytical needs of the burgeoning biologics sector.

MBI at UCL
Modular Training for the Bioprocess Industries (MBI) at UCL
Biochemical Engineering is acknowledged as the leading international provider of innovative UCL-accredited short courses in
bioprocessing. Designed for industry in collaboration with experts
to support continued professional and technical development.

Quote BPI-SEPT2015 when

registering for 100 discount

For further information and bookings please contact:

E: [email protected] I Visit: www.ucl.ac.uk/mbi
T: +44 (0) 20 7679 9619 I +44 (0) 203 549 5619

MBI Awards:
2012 IChemE Award for Training Innovation
2014 UCL Life Learning Enterprise Award for CPD and Short
Courses

DEPARTMENT OF BIOCHEMICAL ENGINEERING

BPI_Sept_UCL_1.indd 1

CPD and Short Courses for

the Bioprocess Industry

8/14/15 2:0

Principles of Fermentation Processes

5-7 Oct 2015

Rapid Fermentation Process Design: From Development to Manufacture

26-28 Oct 2015

Downstream Processing From Cell to Column

16-19 Nov 2015

Downstream Processing Chromatography

30 Nov- 3 Dec

Current Challenges in Mammalian Cell Processing

25-27 Jan 2016

Quality by Design for Effective Bioprocess Characterisation & Validation

22-25 Feb 2016

Cell and Gene Therapy Manufacturing: Getting it right from the start

1-3 Mar 2016

Design of Experiments for Bioprocess Optimisation

7-9 Mar 2016

Industrial Biotechnology: Biocatalysis through to Synthetic Biology

18-20 Apr 2016

Analytical Data Analysis for the Bioprocessing Industry

26-28 Apr 2016

Stem Cell Training Course: Human Pluripotent Stem Cells in Culture

25-27 Apr 2016

Vaccines Bioprocess Development and Commercialisation

17-19 May 2016

Bioprocess Design & Economic Evaluation

6-9 Jun 2016

Bioprocess Facility Design

27-30 Jun 2016

Single Use Technology for Rapid Manufacturing

MBI at UCL
Modular Training for the Bioprocess Industries (MBI) at UCL
Biochemical Engineering is acknowledged as the leading international provider of innovative UCL-accredited short courses in bioprocessing. Designed for industry in collaboration with experts to
support continued professional and technical development.

Quote BPI-SEPT2015 when

registering for 100 discount

11-13 Jul 2016

MBI Awards:
2012 IChemE Award for Training Innovation
2014 UCL Life Learning Enterprise Award
for CPD & Short Courses

For further information and bookings please contact:

E: [email protected] I Visit: www.ucl.ac.uk/mbi
T: +44 (0) 207 679 9619 I +44 (0) 203 549 5619