WHITE PAPER

Biopharmaceutical Informatics

Informatics Role in Biopharmaceutical

Product & Process Development

o deliver safe, life-saving medicines and compete

globally, life science companies are facing enormous
challenges. Not only does the globalized Pharma
industry mean more competition from players around the
world, it also means fielding operations in strategically
important regions to compete in local markets with similar
local players. For example, today, 80 percent of APIs are
manufactured in India and China.
Compliance pressure is steadily growing, and companies are challenged by increased scrutiny from the
U.S. FDA and other regulatory agencies. According to one
source, foreign inspections by the FDA are expected to
increase 17 percent this year. To put that in perspective,
compliance with global standards typically means 35
percent higher manufacturing and maintenance costs.
Meanwhile, governments are putting pressure on the
price. Margins are decreasing and governments have
been successful at negotiating discounts of between 27
and 49 percent off the list price of drugs.
The patent cliff still presents a challenge for all the
industry to bear and many patents have expired or are
about to expire. Some $66 billion worth of sales were
from drugs that had their patents expire in 2015. The
average cost to develop a new drug ranges from $1.2
billion for smaller companies, up to $4 billion for larger
companies and takes an average of 12 years.
Because it takes longer to discover, develop and
market new drugs, productivity in R&D is declining and
BIOVIA

the costs for developing new products are increasing

exponentially. Generics have left their mark on Pharmas
competitive landscape as well. More than 85 percent of
prescriptions written today are for a generic form
of some once patent-protected medicine, and while
Generic Pharma has taken trillions out of the cost of
drugs over the last three decades, competition in this
sector is fierce with former patent holders and generic
companies vying to capture lucrative portions of popular
medications.
Industry observers also point out that Pharmas own
shortcomings challenge itself to a great degree likely
the result of its many years as a closed, insular science-driven industry, ignoring or diminishing the best
practices associated with the other more streamlined
and leaner manufacturing and processing environments.
Many recognize that in contrast to other industries,
pharmaceutical manufacturers are not very efficient at
making drugs and continue to support high-variability
practices from the laboratory to the shop floor. Fortunately, the industry is paying attention, with 50 percent
of multinational companies implementing improvement
initiatives like Lean Six Sigma programs to improve
operational excellence and manufacturing efficiency.
Bristol-Myer Squibb (BMS), for example, was able to
reduce cycle times by 80 percent through its recent Lean
Six Sigma initiative (see sidebar).
Most organizations in the industry share four common

INFORMATICS ROLE IN BIOPHARMACEUTICAL

WHITE PAPER

Biopharmaceutical Informatics

goals: improve quality, reduce cost, boost operational

efficiency and improve innovation. Addressing quality
includes reducing variability in processes and hence,
products which the FDA embraced by introducing
cGMP standards to the industry. For example, the adoption of Quality by Design principles leads to better, high
quality process design. Efficiency initiatives like harmonization, standardization, integration and externalization
support better manufacturing outcomes. Innovation in
the sector will come from many sources, but companies
are fostering it through a number of ways, including
R&D collaborations, engineering new technologies and
highly integrated knowledge management programs.

many organizations have shifted their drug discovery

and development efforts toward biologics and other
protein-based therapies and away from small-molecule
compounds. Similarly, established Biopharma companies are investing a great deal of capital in increasing
processing capability. Baxter, for example, is making
the biggest capital investment in its history spending
some $1 billion on a new Albumen processing plant in
Georgia.
This shift shows real promise. Recently there has been
amazing growth in this sector. BCC Research (Biologic
Therapeutic Drugs: Technologies and Global Markets
Jan. 2015) reported in 2013 that the global biologics
market reached $200.6 billion and that it was expected
to grow to nearly $234 billion in 2014. By the end of
2019 the total market is expected to grow to $386.7
billion at compound annual growth rate (CAGR) of 10.6
percent. This growth can be attributed to:

The Increasing Importance of Biologics

Advances in drug development are driving industry innovation, especially in biopharmaceuticals and biologics.
And even though some of those drugs are losing patent
protection, they dont face imminent competition from
generics because of the regulatory climate (biosimilars
are only now being approved by U.S. regulators) and the
operational difficulties associated with biopharmaceutical processing. By most measures, the Biopharmaceutical category has great potential to continue its money-creating ways, so in an effort to improve innovation

Superior efficacy
Premium pricing
12 year exclusivity (U.S.)
Biosimilars being difficult and expensive to develop
and approve
Satisfying previously unmet clinical needs

Biologics
ProductLifecycle
Development Life Cycle
Biologics
Product Development
Information
Management
the Product Life Cycle
Information
Management
Throughout Throughout
the Product Lifecycle
Target Identification
and Validation
Predictive Analytics
Cloning and
Expression
Assay Development

Lead Identification
Sequence Analysis
Activity Analysis
Developability
Calculations

Characterization
and Optimization

Safety
and Preclinical

Biophysical/ chemical
Affinity Maturation
Humanization
Validated
Monoclonality

Cell Culture,
Recovery/Purification
Formulation/Delivery
Process Development
Stability

Manufacturing
and Regulatory
Scale-up
Process Optimization
and Monitoring
Product Optimization
Regulatory
Compliance

Information Management
Discovery Informatics

Development Informatics
Informatics
Manufacturing
Informatics

BIOVIA
Wednesday,
July 15, 15

INFORMATICS ROLE IN BIOPHARMACEUTICAL

39.5%

ocess workflow

WHITE PAPER

Biopharmaceutical Informatics

Information Systems Wanted and Needed

When it comes to the biologics product development
lifecycle, information management is an imperative that
cannot be ignored. Product development is comprised
of five primary segments including target identification
and validation, lead identification, characterization and
optimization, safety and preclinical, and manufacturing
and regulatory. Underlying these segments are R&D tasks,
activities associated with clinical elements, data gathering
and analytical activities, as well as tasks associated with
the processing and commercial production of the drug.
Development Informatics systems need to support all
these areas and activities and at the same time link to
the applications of the other areas upstream and downstream in the process. Development Informatics is also
part of the unique overall BIOVIA Biologics solution that
covers Discovery, Development and Manufacturing. To
explore the uptake and efficacy of information technoloNot Applicable
gies in support of biopharmaceutical operations, BIOVIA
1.9%
partnered with Pharmaceutical
Manufacturing magazine
(PhM) to survey
leading biopharmaceutical manufacImportant
turers to better23.2%
understand current biopharmaceutical
Very
product and process development challenges.

Important
48.2%
Somewhat
The Most Challenging
Important
5.6%the
Given that in
biopharmaceutical
manufacturing
Critically
process isImportant
the product, the 111 surveyed R&D, QA/QC,
manufacturing,
operational and compliance executives
17.6%
rightly ranked Bioproduction
Optimization as the numNot Very
ber one challenge
when
it
comes
Important 3.7%to biologic development

processes. Among the other choices (Regulatory, Quality

and Compliance, Document and Data Management and
Sample Management) all were ranked similarly with no
particular challenge a clear leader.
BIOVIA interprets this to mean that as an organization, it is important to focus on supporting all of the
challenge areas equally.
From a process perspective, the survey participants
made it very clear that bioproduction optimization and
quality and compliance do have the highest need of
improvement and support. Documentation, data and
sample management are perceived as less challenging
34.9%
60.5% but 53.5%
to study respondents,
only as a matter34.9%
of degree
because
all
the
areas
are
important.
Registration and
Documentation and Process and quality Regulartory, quality,

sample workflow

BIOVIA

data management

data aggregation and

analysis

and compliance
management

Please rank the areas of your biologic development

process that are the most challenging for your
organization?(1 is the most challenging; 4 is the least
challenging)
Process Development

Rank Weighted Score

Bioproduction Optimization
Regulatory, Quality and
Compliance Management
Document and Data Management
Sample Management

304

278

197

179

265

259

240

204

Product Development

Formulation Development
Process Development
Drug Substance Identification/
Characterization
Preformulation Characterization

Development Data Delayed? It Depends

Do respondents believe that It takes too long to interpret data critical to biopharmaceutical product develYesare split nearly
opment? Here, responding executives
50/50, something that
is
notable
because
40.7% in BIOVIAs
No
experience, the delay in obtaining critical data has been
59.3%
identified as a real bottleneck by many, but the studys
next query and its results may explain why half this
group thinks it gets its data in a timely fashion and the
other half does not.

Do you believe that it takes too long to interpret

data critical to biopharmaceutical product development within your organization?

INFORMATICS ROLE IN BIOPHARMACEUTICAL

Yes
50.9%
No
49.1

50.9%
No
49.1
WHITE PAPER

34.9%

Biopharmaceutical Informatics

Are you using manual methods (like pen and paper

and/or Excel) to support all of or part of your
biopharmaceutical development process?

gulartory, quality,
and compliance
management

No
38%

24.6%
50-74%

Yes
62%

21.5%
25-49%

43%

teams of the
above

Study participants were asked are you using manual

methods (like pen and paper and/or Excel) to support
23.1%
all of or part of your biopharmaceutical development
75-99%
process? The majority (62 percent) responded their
organizations are indeed slaves to the pen or the spreadNot Applicable
sheet as they accumulate and transmit data across the
1.9%of manual methods,
enterprise. Regarding the percentageNo
almost half of the
respondents23.1%
indicated
24.6%
Important
30%at least 75
percent of their50-74%
biologic
development
23.2%
75-99%process is supported
Very methods; Yes
by manual
21 percent said 100 percent of their
70%
Important
methods are manualand all the others, to a small
48.2% 21.5%
Somewhat
21.5%
percentage, rely on manual processes.
According to survey
Important 5.6%
respondents,25-49%
about
60 percent indicated
Critically
100% they are not using informaticsImportant
at all to support their processes,
9.2% solutions
17.6%
something BIOVIA confirms from its experience introducVery
ing 0-24%
informatics technologiesNot
to the
Pharma universe.

Important 3.7%

39.5%

s Bioprocess workflow

80
70
60
50
40
30
20
34.9%
10
Registration
0 and
sample workflow
BIOVIA

60

Approximately what percentage of your biopharmaceutical

development process is being
23.1%
supported with manual methods like pen/paper
75-99%
and/or Excel spreadsheets?

23.1%
75-99%

Very
Important
48.2%

21.5%
100%

9.2%
0-24%
Are you using informatics solutions to support
all or part of your biopharmaceutical development80process? Not Applicable
70
1.9%
60
Important
50
23.2%
Very
Yes
40
Important
40.7%Somewhat
30
No
48.2%
59.3%
Important 5.6%
20
Critically
10
Important
67.4%
41.9%
39.5%
17.6%
0
Analysis of
Predictive analystics Bioprocess workflow
biology data Not Very
Important 3.7%

34.9%
Registration and
sample workflow

Which areas of your biopharmaceutical development process are currently

60
supported by informatics solutions? (multiple answers permitted)
50
Yes
40
50.9%
30
No
49.1
20
60.5%
67.4%

53.5%
41.9%

34.9%
39.5%

Documentation and Process and quality Regulartory, quality,

of
Predictive
analystics
workflow
dataAnalysis
management
data
aggregation
and Bioprocess
and compliance
biology data
analysis
management

10
34.9%
0
Registration and
sample workflow

54.2%
53.3%
58.9%
60.5%
53.5%
34.9%
Leaders in research
Leaders in quality
Leader in process
& development
and quality
regulartory
development
Documentation
and Process and
Regulartory, quality,
data management data aggregation and
and compliance
analysis
management

INFORMATICS ROLE IN BIOPHARMACEUTICAL

55.1

Leaders
manufactu
operati

WHITE PAPER

Biopharmaceutical Informatics

23.1%
Enter Informatics
75-99%
Of those companies that do use informatics to sup23.1%
port
biopharmaceutical development processes, some
6775-99%
percent say they use the technology to analyze
biology data. Documentation and Data Management
(60.5 percent)24.6%
and Process and
Quality Data Aggre23.1%
gation and Analysis
(53.5
percent)
50-74% 75-99%followed, revealing that the analysis
and management
24.6%
23.1%of data and
documentation are50-74%
most supported
by informatics
75-99%
21.5%
21.5%
solutions. This result helps explain
why data interpre25-49%
tation is not
perceived
as
a
challenge
100% by half of the
21.5%
studys respondents. Interestingly,21.5%
Sample Workflow
9.2%
25-49%
100%Management
and Regulatory, Quality and Compliance
0-24%
garnered
lower
9.2%usage scores, even though quality is
considered
one of the key goals for many life science
0-24%
organizations and a challenge on the biologics development level as demonstrated by the responses to the
80 This may reveal that an informatics solution
survey.
for
70this80area might serve a companys compliance
strategy. At the very least these key activities are
60 70 by an electronic system.
supported

How important is it to your organization to

access real-time project tracking and collaboration with various
groups involved in the
Not Applicable
development process? 1.9%
Not Applicable
Important
1.9%
23.2%
Very
Important
Important
23.2%
48.2%
Somewhat
Very
Important 5.6%
Important
48.2% Critically
Somewhat
Important
Important 5.6%
17.6%
Critically
Important
Not Very
17.6%
Important 3.7%
Not Very
Important 3.7%
This is no surprise as both are basic for efficiency
and innovation two major goals of the life science
industry.

50 60
Project
Responses to the question: Who do you feel would
40 50 Tracking in Real Time
How important is it to your organization to be able to
benefit from a comprehensive software suite to help
30 40
deliver Real Time Project Tracking and Collaboramanage the complex process of developing and
20
30
tion with various groups involved in the development
commercializing biologic drug therapies? indicated,
process?
Respondents
generally
agreed
this
functioninterestingly enough, that Supporting Teams and IT
10 20
67.4%
41.9%
39.5%
34.9%
60.5%
53.5%
34.9%
ality is10
key for almost everybody (about 90 percent).
leaders would benefit least. This was a bit surprising
0
41.9% Bioprocess39.5%
34.9%
60.5%
53.5%
34.9%
Analysis67.4%
of
Predictive analystics
workflow
Registration
and
Documentation
and Process
and quality Regulartory,
quality,
biology
data
sample
workflow
data
management
data
aggregation
and
and
compliance
0
Analysis of
Predictive analystics Bioprocess workflow
Registration and
Documentation and Process
and quality Regulartory,
quality,
analysis
management
biology data
sample workflow
data aggregation
and
and compliance
Who do you feel would
benefit from a comprehensive software
suitedatatomanagement
help manage
the complex
analysis
management
process of developing and commercializing biologic drug therapies? (Please check all that apply)
60
50
40
30
20
10
0

BIOVIA

60
50
40
30
20
10
0

54.2%
54.2%

53.3%
53.3%

58.9%
58.9%

Leaders in research
Leaders in quality
Leader in process
Leaders in research and regulartory
Leaders in quality
Leader in process
& development
development
& development
and regulartory
development

55.1%
55.1%
Leaders in
Leaders&in
manufacturing
manufacturing &
operations
operations

INFORMATICS ROLE IN BIOPHARMACEUTICAL

29%
29%

43%
43%

Leaders in
Leaders in
information
information
technology
technology

Support teams of the

Support
teams of the
above
above

WHITE PAPER

Biopharmaceutical Informatics

Biologics Process Challenges and Business Impact

Challenges

Business Impact

U nderstand high-volume antibody sequence data,

genealogy and link of data entities

Innovation barrier

Hindered collaboration

 Inefficient, paper-based workflows

N on-value add manual data transcription

Low productivity and efficiency

M
 anual data management with tedious policies
Difficult data access and sharing

Little collaboration

No reliable, provable data quality and integrity

High compliance risk

No consistent and comparable processes

No real-time project tracking

Long cycle times

 Insight into bioprocess scale-up

because in BIOVIAs experience, IT and supporting

teams do benefit, and to a large degree. Ultimately,
the leadership in R&D, Quality/Regulatory, Process
Development and Manufacturing & Operations, as
well as Support Teams and Information Technology,
all can benefit from a comprehensive solution.

Process Challenges Have Business Impact

When informatics arent applied well or integrated to
serve the entire enterprise, biologics process challenges can have a real impact on business. Difficulty
understanding high volume sequencing data or creating collaboration among groups could be an innovation killer. Inefficient paper-based workflows, manual
data transcription and tedious manual data management often lead to low productivity. Ponderous data
BIOVIA

access and difficulties sharing it often limits collaboration, and the compliance risks associated with
being unable to demonstrate the quality and reliability of data are also well known. When an organization
cant track projects in real time or lack insight into
scale-up, cycle times will suffer, constraining operations and impacting speed-to-market.
BIOVIAs Biologics Development solution can benefit
any biopharmaceutical enterprise. BIOVIAs dedicated
solution supports all aspects of the experiment workflow. (As a true multi-discipline system, it can even
go beyond covering the requirements for chemistry
too.). The solution integrates BIOVIAs Electronic Lab
Notebook capabilities with a Bioregistration system, an
inventory management solution for materials and consumables, and an instrument inventory management

INFORMATICS ROLE IN BIOPHARMACEUTICAL

WHITE PAPER

Biopharmaceutical Informatics

Capabilities and Business Value

Capabilities

Business Value

Easier and better understanding of processes

Faster & better innovation

Enabled tech transfer

Removed inefficient paper-based workflows
Automated data management

Increased productivity and efficiency

Streamline experiment creation and reporting

Easy retrieval of data from different sources

Improved collaboration

Access to data internally and externally

Standard work practices and processes

Improved data quality and integrity, reduced errors

Improved regulatory compliance

Real-time project tracking

Reduced cycle times

Faster decision making by better insight on data

solution that includes metrology. BIOVIAs end-to-end

solution covers Discovery, Development and Manufacturing and the Quality aspects of Biologic processing.
Heres how:
F aster, better innovation through easier and better understanding of processes and enabled tech
transfer between the different domains upstream
and downstream.
Increased productivity and efficiency by removing
non-value-added activities inherent in inefficient
paper-based workflows, automating the management of the scientific data and by streamlining
the experiment creation and reporting.
Improved collaboration through easy retrieval of
data from different sources and data silos withBIOVIA

out having to move the data from their original

location and by the access to data from different
groups within the organization as well as externally with collaborators like Contract Research
Organizations or Contract Manufacturing Organizations.
Regulatory compliance improvement through
standard work practices and processes and
improved data quality and integrity as well as
reduced errors.
Real-time project tracking and faster decision
making by better insight on data allows for
reduced cycle times.
Ultimately, the solution helps to drive innovation
and bring products to market faster.

INFORMATICS ROLE IN BIOPHARMACEUTICAL

WHITE PAPER

Biopharmaceutical Informatics

CASE STUDY A GLOBAL PHARMACEUTICAL R&D COMPANY

CREATING AN INTEGRATED ELECTRONIC
WORK FLOW
The lifecycle of an analytical method spans from method development through method validation to method
execution for sample analysis. The process involves
numerous experiments, reports and data/document
reviews over the complete lifecycle. Traditionally, different systems, including paper and electronic, handle
discrete parts of the process. As a result, extensive
manual data transcription, verification and final review
are required. In collaboration with BIOVIA, a major
branded pharma companys informatics team designed
an integrated electronic flow using existing features of
the BIOVIA Workbook such as vault workflow, Empower
adapter, integration with Instrument Management and
Lab Execution System and Pipeline Pilot reporting. A
cost/benefit analysis of this integrated workflow was
done as well.
Among its business goals, the pharmaceutical manufacturer sought to support an expanded portfolio of
molecules, an increase in early-stage work and to foster
more late stage successes and less attrition. The initiative was also driven by compliance goals in an effort to
pursue FDA critical path initiatives while demonstrating
better process understanding. Ultimately, the companys
overarching desire was to ensure compliance was part of
an aligned corporate compliance strategic objective.

Business Strategy
To attain the initiatives goals, BIOVIAs customer pursued
productivity gains by examining workflows, improving
processes and deploying productivity tools. Reducing
dependence on paper processes, leveraging prior experience in development and using in-silico approaches were
all understood to support the productivity gains required
to meet its business strategy and improve compliance by
eliminating opportunities for error and neglect, capturing
information securely while improving review and oversight.

Information Management Strategy

The pharmaceutical companys information management strategy was simple: capture and secure information (data and its context) at the time of its creation.
Data and its context are most relevant and understood
when its created. Changing context to record data
reduces its fidelity; information needs to be useful and
reusable. With BIOVIAs solution, the companys operational teams are better equipped to organize information to maximize its use in decisions and help reduce
or eliminate rediscovery or reinvention. With BIOVIAs
Biologics solution the companys managers can mine
electronic information to find new insights, leveraging integrated information including information
from unrelated workflows and disparate sources to
improve decision making.

Informatics Delivered Dramatic Benefits:

COMPLIANCE & QUALITY
M
 ore rigorous execution of methods
A utomated data capture
U niformity of workflow and presentations
within notebooks
Imbedded calculations and review by
exception
D ata traceability
Cross PD availability of data and information
Improved SOP adherence

BIOVIA

PRODUCTIVITY
Electronic workflow (standard process,
standard structure)
Electronic review
Global visibility and search capability
Experiment and data reuse rather than
reinvention
Re-use of chemistry, formulation
and methods
Standardization and reduced
environmental complexity

INFORMATICS ROLE IN BIOPHARMACEUTICAL

COSTS & BUSINESS RISKS

Reduced material costs
Avoided staff and administrative costs
Greater IP security
Improved process understanding
Improved data management and
archiving
Integrity of Informatics
Improved Process Execution

WHITE PAPER

Biopharmaceutical Informatics

About Dassault Systmes

Dassault Systmes, the 3DEXPERIENCE Company,
provides business and people with virtual universes
to imagine sustainable innovations. Its world-leading
solutions transform the way products are designed, produced, and supported. Dassault Systmes collaborative
solutions foster social innovation, expanding possibilities for the virtual world to improve the real world.
The group brings value to over 190,000 customers of
all sizes, in all industries, in more than 140 countries.
BIOVIA provides a scientific collaborative environment
for advanced biological, chemical and materials experiences. The sophisticated enterprise system of modeling,
simulation, laboratory, and quality management enables
innovation for science-based industries.
For more information, visit:
www.3ds.com/products-services/biovia/

Dassault Systmes
175 Wyman Street
Waltham, Massachusetts
02451-1223
USA

BIOVIA Corporate Americas

BIOVIA 5005 Wateridge Vista Drive,
San Diego, CA 92121
USA

This whitepaper, as well as the previously released recorded presentation and industry survey conducted
by Pharmaceutical Manufacturing were sponsored by BIOVIA (formerly Accelrys). To learn more about
Informatics from BIOVIA, see the following links:
Click here to view the full results of the Biologics Development survey
Click here for the Biologics Development recorded webinar
Click here for the BIOVIA Biologics Datasheet
Click here for the BIOVIA Biologics Development Datasheet
Click here for the BIOVIA Biologics Development Video Overview

BIOVIA

INFORMATICS ROLE IN BIOPHARMACEUTICAL