beyond operational excellence through digital...

© 2016 Iyno Advisors www.iyno.com

Sustainable Health for

Biopharmaceutical Manufacturing

Beyond Operational Excellence

through Digital Continuity

by Julie Fraser and Amy Rowell

A holistic approach is crucial for the well-being

of patients and companies

Modernizing manufacturing and IT systems are paths industry leaders and regulators believe can result in safe,

affordable, and efficacious drugs, but small improvements may not be enough. Biopharmaceutical companies

are facing multiple challenges including increasing development costs, shifting outcomes-based economic

models, and ever evolving global compliance needs. To combat these challenges, companies are required to

completely realign their offerings, processes, supply chains, and business structures to facilitate innovation,

agility and sustainable high quality.

By better understanding the manufacturing process, a pharmaceutical manufacturer can transform its business

and better manage these conflicting challenges. This knowledge allows a company to achieve faster, more

successful new product ramp-ups, more efficient technology transfer, improved plant performance, and more

business breakthroughs. It can also more readily identify the best manufacturing processes and strategies for

meeting the needs of customers in specific geographies or markets.

To enable this, industry leaders and regulators envision the use of holistic knowledge management systems to

better support innovation efforts and deliver assured compliance. This enables a company to leverage

modeling, simulation and process monitoring tools within a common platform to facilitate performance and

process improvements. Mechanisms for effective data collection, sharing,

and analysis are the foundation of streamlining efforts required to meet

development and manufacturing timelines, as well as regulatory

obligations. Since so many people across numerous diverse domains are

involved in the product lifecycle – both internal and external to the

company – it’s critical that a digital continuity strategy be put in place to

enable global collaboration and faster decision-making and to proactively

support regulatory requirements.

The good news is that there are logical ways to start down the path.

Those who have done it are sharing positive results already, and

regulators have taken notice. The message is clear - wellness programs

are paying off, both for patients and for organizations. As with any

wellness program, the key is to take a holistic and transformational

approach.

Streamlined process

development & start-up

Fast submissions and

approvals

High quality and yield

Low process and product

variability

A sustainable supply chain

An accessible, complete

knowledge base

Beyond Operational Excellence with Digital Continuity



Table of Contents

Industry Challenges .................................................................................................................................. 1

Current Approaches that Fall Short .................................................................................................... 2

Digital Transformation............................................................................................................................. 2

IT for Digital Continuity ........................................................................................................................... 5

IDMP – What and Why? ......................................................................................................................... 7

Pragmatic Ways to Get Started ............................................................................................................ 9

A Sense of Urgency - Planning for the Future ............................................................................... 10

Note: This paper is based on The Holistic Approach to Pharmaceutical Manufacturing: Product Lifecycle Management

Support for High Yield Processes to Make Safe and Effective Drugs © 2011 Cambashi, with revisions and updates by Iyno.

Dassault Systèmes

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© 2016 Iyno Advisors 1 www.iyno.com


Industry Challenges

The pharmaceutical industry is on the verge of a new

era – characterized by a preventive and personalized

approach, rather than prescriptive and volume-

driven. In order to address this shift, many

pharmaceutical manufacturers are realizing that they

must reinvent themselves.

These companies face a myriad of external pressures

and challenges on this journey:

a proliferation of ever-changing regulations that

can drive manufacturing costs higher

a new commercial landscape with new regional

markets, new competitors, and a growing demand

for health and wellness “solutions” not just

products

payers focused on treatments with top outcomes

and shifting to outcomes-based pricing

an increase in outsourcing and a rise in the use of

CMOs (contract manufacturing organizations)

first-to-market pressures and the ability to clearly

demonstrate scientific leadership to

maintain that headstart

All of this comes at a time of significant patent

expirations for many blockbuster drugs, and

the need for new R&D models to facilitate the

development of precision medicine for specific

populations.

Together, these forces are driving

manufacturers to make some major changes

to maintain profitability without sacrificing

safety and efficacy for patients. Across the

industry, manufacturers of branded, generic,

and over the counter (OTC) therapies must

shift their business processes to succeed.

Making medicines for smaller and more

specific patient populations is a clear path to

company success with drugs that are targeted

and thus more effective, while delivering on

the same high safety expectations. Despite the

sound business logic, this is not an easy path.

The resulting product proliferation adds significantly

more complexity and cost to business operations.

Moving a multitude of product variants through

development, into and through trial production,

regulatory approval, and full-scale production quickly

and efficiently is an enormous challenge.

Historically, biopharmaceutical companies have not

invested in manufacturing and supporting

information systems as much as they have in R&D

and marketing. This relative neglect of manufacturing

systems has led to a long list of industry problems

and negative results that regulators, shareholders,

and the public all want to change. Figure 1 illustrates

just a few of these, along with causes. Some

production processes suffer as much as 50% waste.

The result is a very high level of effort and cost to

achieve consistently high quality product.

These inefficient production practices are not

acceptable with the cost-sensitive environments of

national health insurance programs and emerging

markets. The move to “go global” and produce

medicines for smaller patient populations will only

compound these problems.

Problem Cause(s)

High production cost for

products

Low yield and efficiency, waste,

time to test, batch switches, etc.

Drug shortages 65% from manufacturing &

quality problems

Lack of improvements

based on new technologies

Fear of changing validated

manufacturing processes

Slowed development and

access for investigational

drugs

Inefficient transfer of new drugs

into manufacturing and uncertain

scale-up

Need for intensive

regulatory oversight

Poor root cause analysis of

manufacturing failures

Shortages data from Modernizing Biopharmaceutical Manufacturing to

Improve Drug Quality, FDA Voice Feb 1, 2016.

Figure 1: Many industry problems are caused in manufacturing,

and biologics further complicate production.




Current Approaches that Fall Short

Biopharmaceutical manufacturing executives must

recognize where their current approaches fall short

and develop a path to ensure the sustainability of the

company. Representatives from regulators as well as

the International Conference on Harmonisation of

Technical Requirements for Registration of

Biopharmaceuticals for Human Use (ICH) have

presented some of these shortcomings in a

systematic way. Briefly, they include:

Quality by test or managing quality through off-line

analysis will increase the cost and time to achieve

high quality, as it allows products that will not pass

final tests to go through the process. The result is

increased cost, cycle time, and risk, as the company

scraps products and requires a second production

run to get acceptable quality product manufactured.

Issue correction without prevention raises the risk

that problems will occur that could have been

avoided. Prevention must be built into the design of

the production process itself instead of corrected

when problems have already affected the process or

product. This is what regulators are demanding with

Quality by Design (QbD). Many biopharmaceutical

makers are not equipped to understand and execute.

Silos of data and knowledge owned by different

departments or disciplines means valuable data is

often not used as context for decisions about the

product and production process. This is true not only

from stage to stage (development to clinical trials to

full production), but also in some cases among the

groups that service production and process

development, such as statistics and multivariate

analysis, spectroscopy, mathematical modelling, and

risk assessment.

An empirical or variable-by-variable approach to

product development results in a costly and slow

process. It is also vulnerable to blind spots because it

cannot account for the interaction between variables

that frequently cause problems in trials and in scaled-

up full production. Even in multi-variate approaches,

the focus on an average rather than the distribution

of outcomes and minimizing variability (i.e.,

minimizing the likelihood of batches that are out of

specification) can limit production success.

Change-resistant validated processes limit the

companies’ interest in pursuing new technologies

and process improvements that would result in higher

quality and yields at lower cost. Regulators are

attempting to shift that with design space allowances

and new technology support.

Understanding these shortcomings of the current

process development approach, regulators and the

ICH have started to promote the adoption of more

tightly integrated, data-driven approaches. Across

the industry, leading biopharmaceutical producers

are beginning to shift their business processes to new

digital approaches that better leverage product and

process knowledge.

Digital Transformation

To address the challenges of complexity and

knowledge management, biopharmaceutical

manufacturers are investing in a digitally-driven

approach to collecting, managing, accessing and

analyzing critical product and process data. By

harmonizing all of these sources of information, it

creates digital continuity across several dimensions:

Across disciplines

Between products and production processes

Among partners and suppliers across the globe

Throughout the lifecycle

From one generation of product to the next

The ultimate goal is to capitalize on the wealth of

data being generated by collecting it in context to

Understand and simplify

“Dassault Systèmes Solutions, including BIOVIA

Discoverant , gave us an improved understanding

of our process monitoring operations and greatly

simplified data aggregation and visualization.”

Scientist, Global 500 Pharmaceuticals Company

Quotes from Survey conducted by TechValidate, May 2014




become actionable knowledge and insight. The

resulting digital transformation aids in reducing risks

and the need for regulatory oversight. Safe,

efficacious products are the natural outcome of such

digital orientation.

Figure 2 shows how the needs during process design,

process scale-up, production operations, and process

improvement stages can all contribute to a

knowledge base. This graphic includes certificate of

pharmaceutical product (CPP), critical quality

attributes (CQA), scale up and continued process

verification (CPV), annual product review (APR) and

product quality review (PQR), identifying and

reducing variability, and scale-up and post-approval

changes to manufacturing equipment (SUPAC). Even

beyond the needs shown here, a common data

storage, retrieval and documentation system can

help a biopharmaceutical enterprise in making good

decisions.

The benefits of such digital continuity serves patients,

payers, physicians, partners and the company. In

particular, by focusing on the “core” of

biopharmaceutical manufacturing – the

manufacturing process - and implementing data-

driven process monitoring tools to facilitate

performance and process improvements – a

biopharmaceutical manufacturer can achieve a

number of key benefits:

lower process variability and costs

improved supply chain predictability

inventory reductions & higher yields

improved traceability

higher quality outsourcing

faster time-to-market

more successful new product introductions

Manufacturers are also able to more readily identify

the best manufacturing processes and strategies for

meeting the needs of customers in specific

geographies or markets.

Figure 2: Challenges during process design, process scale-up and operation, and process

improvement all benefit from sharing common data. It’s even more beneficial if these also share

with R&D, marketing, clinical, and all disciplines.




Digital continuity also enables proven process

improvement tools like Quality by Design. QbD and

the ICH 10 pharmaceutical quality system (PQS) offer

a product/process lifecycle approach based on

continuous improvement, as illustrated in Figure 3.

Here, a knowledge repository that supports and

encourages data sharing and collaboration can make

quality data accessible to everyone. Ultimately,

biopharmaceutical manufacturers are seeking to

access and leverage all available and relevant data to

improve manufacturing process design, planning,

monitoring, and logistics. These four operational

areas are so closely related they must support each

other to be fully effective, as in Figure 4.

This is where digital continuity can make a difference.

Digital continuity provides visibility and traceability

across the entire process. The focus is on leveraging

and sharing data across applications and disciplines

for greater collaboration, improved quality and

reliability, and more informed decision-making,

enabling biopharmaceutical manufacturers to

transform their business processes, accelerate

innovation and manage the growing complexity of

drug development.

To accelerate discovery, development and

manufacturing, the ability to easily access and

manage relevant data and information is essential.

Here again, digital continuity can play a key role.

As outlined in the International Conference on

Harmonisation paper “Q12: Technical and Regulatory

Based on graphic in article Challenges in Implementing Quality by Design: an Industry Perspective

by Michael Torres in Bioprocess International, June 16, 2015

Figure 3: Digital Continuity supports the Quality by Design (QbD) integrated science and risk-based approach with

continuous improvement for the entire product life cycle, but all aspects of.the Pharmaceutical Quality System (PQS).

ICH Q 10 shows knowledge and quality risk management, which digital continuity delivers, as enablers.

Figure 4: The four operations pillars of process design,

planning, monitoring and logistics can integrate

effectively if they rest on digital continuity.

Digital Continuity to support the Pharmaceutical Quality System (PQS)




Figure 5. Digital continuity enables companies to gather, store

and analyze multiple disciplines’ data throughout the product

lifecycle into a useful knowledge repository.

Considerations for Biopharmaceutical Product

Lifecycle Management,” the biopharmaceutical

industry can benefit from a platform that creates a

seamless and continuous data flow to facilitate

accelerated approvals.

In addition, digital continuity can provide much-

needed transparency throughout the lifecycle of a

product - from early clinical trials, through

manufacturing, and to full commercialization. This

enables biopharmaceutical manufacturers to identify

potential formulation or sourcing issues to avoid the

risk of a costly product recall. Such transparency also

provides both decision and process traceability

across all variations at both the product and country

level. This, in turn, helps to streamline supply chain

information and to facilitate traceability in the event

of a recall.

Additionally, because digital continuity improves

information sharing across all phases of the

manufacturing process - from planning and

execution to monitoring and logistics - more

informed decision-making at every stage in the

product development and delivery process is

possible (see Figure 5).

This helps to drive operational efficiencies, speed

production, establish a culture of continuous

improvement and enable knowledge-based decision

making across all aspects of product development –

driving ongoing improvements in product safety,

quality, and reliability.

Indeed, coupled with such initiatives as Quality by

Design (QbD), Process Analytical Technology (PAT),

Process Robustness (PR) and Continued Process

Verification (CPV) digital continuity is especially

powerful. For example, sound CPV practices for

ongoing production help establish control limits to

ensure high yield and consistent quality. Feeding

back from CPV to risk assessment and scale-up

activities for similar products in earlier stages of the

lifecycle can improve outcomes for years to come.

Regulators point out these approaches to help

ensure patient safety and lower costs.

But just what exactly does IT need to deliver to

support digital continuity for biopharmaceutical

manufacturers?

IT for Digital Continuity

The vision of digital continuity is to deliver an

integrated, data-driven, knowledge-based platform

approach to manufacturing, and includes

components that support all aspects of the

manufacturing process from concept through

delivery.

In order to achieve digital continuity in

biopharmaceutical manufacturing, a platform

and a set of software applications dedicated

specifically to biopharmaceutical manufacturing

are required. However, this is rarely the case

today.

Figure 6a shows the struggle most companies

encounter when trying to manage multiple,

disparate data sources across the lifecycle. The

various teams often cannot leverage each

other’s work fully. They typically use different

terminology, have different viewpoints, use and

create different data, and leverage independent

information systems. While everyone involved

is theoretically striving toward the same goal,

these information disconnects can lead to a




lack of understanding and incomplete risk analysis.

This is the fundamental issue the Identification of

Medicinal Products (IDMP) is striving to address. (See

sidebar: IDMP – What and Why?) With a standard

approach to terminology, at least it will be clearer

which products and ingredients are the focus. Figure

6b illustrates digital continuity enabled by an

integrated IT backbone. This builds even beyond the

IDMP continuity. At the core are a common

knowledge repository, workflow and predictive

analytics built on a single platform. In addition,

industry-specific software applications can support all

of the disciplines of biopharmaceutical

manufacturing. This IT approach brings together all

relevant information from various sources and

delivers structured processes by which all disciplines

can work together to improve product quality

proactively.

Such applications can aid in the discovery and

analysis of both chemical and biotherapeutic

candidates as well as the optimization of the overall

workflow, including development, manufacturing and

compliance processes. These applications can also be

used to document experiments as well as support the

management and analysis of all scientific and quality

data generated throughout the process.

More specifically, key applications to support a digital

continuity vision in biopharmaceutical manufacturing

include:

Document and data management: At the heart of

any data-driven digital continuity effort is information

management and a global collaboration platform.

Companies need to store and easily access both

database-resident structured data and “unstructured”

data from drawings, documents and other sources.

For biopharmaceutical companies, in particular, data

management applications are used to document and

manage the flow of information, tasks and materials

within and between disciplines - integrating scientists,

instruments, solutions and information.

Figure 6: Siloes and disconnected information systems are common today (6a left); IT for digital continuity (6b right)

enables more effective collaboration, based on collection, storage, analysis, and leverage of critical product and process

data from concept through delivery via common data management, workflow and advanced analytics.

Figure 6b Figure 6a




IDMP – What and Why?

Identification of Medicinal Products (IDMP)

enables a single product definition across

functions and partners, not only helping

support compliance but also improve business

process and data management efficiency.

IDMP is a set of five standards published by

ISO in 2012 in response to a demand for

international harmonization of the

identification, characterization and exchange

of medicinal products information. IDMP

supports activities related to the development,

registration and lifecycle management of

Medicinal Products.

The standards for IDMP focus on definitions

and common data formats for the following:

medicinal products (ISO 11615),

biopharmaceutical products (ISO 11616),

substances (ISO 11238), units of

biopharmaceutical dose forms, units of

presentation, routes of administration and

packaging (ISO 11239), and units of

measurement (ISO 11240).

“The Implementation of IDMP will be

transformational across all stakeholders adding

value and capabilities unachievable in the past”

“IDMP Industry Perspective”, John Kiser –

Co-Chair, IDMP Task Force Group

Data search & retrieval: Employees must also be able

to access a wide array of technical, statistical and

other types of data to effectively use the broad

knowledge base around each product, process,

partner, and ingredient or material. To arrive at good

business decisions, the system must find correlations

in seemingly unrelated data from inside, outside or

the web, and deliver dashboards or reports, ideally

without user training or schema design and

application coding. For biopharmaceutical

companies, this includes tools for building and

managing consistent, searchable, and shareable

corporate compound registries. This includes sample

management tools to search across a sample’s

lifecycle.

Analytics and intelligence: This includes tools to see

process performance, quality and compliance risk, as

well as improved understanding and control of

process and product variability. Even with relevant

data, meaningful interpretation of the data can be a

challenge. Sophisticated data analysis can help

identify best practices, and relate design intent to

product outcomes and production process data. For

biopharmaceutical manufacturers, in particular, this

involves leveraging IT to understand past issues and

using those as context for where processes are likely

to trend out of the design window, and see the

impact of changes in ingredients or suppliers.

Product data correlations: The foundation for

product development is structured product

parameters and attributes as well as the formulations

that will achieve those outcomes. Digital continuity

for biopharmaceutical companies provides

contextualization and meta-data to use these

consistently. This, in turn, enables a company to

relate risk analysis, statistical analysis, biological and

chemical data to each product, recording the basis

for design decisions made at each step for each

product. For biopharmaceutical manufacturers, this is

part of the discovery & analysis process, which

includes applications to simplify the analysis of

biology data, with capabilities such as: antibody

discovery (e.g. annotation, alignment, clustering, and

activity data correlation) and single cell validation and

cell growth detection.

Regulatory, quality, and compliance: It is essential to

have a proven validation-ready solution for

managing data, content and processes for quality

assurance and regulatory compliance. In this area,

leading applications include capabilities for managing

regulatory submissions, document and content

management including compliance to the new IDMP

format, non-conformance and CAPA management,

change control, complaints, audits, policy and

procedure management, corporate ethics and

compliance, reporting and dashboarding, etc. (See

Figure 7, which compares strategies that support

minimal requirements for ICH Q8, extended QbD and

digital continuity.)




Supporting Biopharmaceutical Development

According to ICH Q8 Guidelines

Leveraging Digital Continuity to

Transform Biopharmaceutical

Development Health Minimal

Requirements Enhanced, QbD

Fixed manufacturing

process

Manufacturing process

adjustable within the

design space

Structured change management based

on specifications and analysis

Focus on

reproducibility

Focus on control strategy

and robustness of the

process

Virtual manufacturing with simulation of

the process and product outcomes

Off-line analysis PAT tools used for feed

forward and feedback

process control

Process design creates control

parameters, and data management

handles data from process control

Quality assured by

testing

Risk based control

strategy (real-time

release)

Risk management analysis data stored

and in context and accessible

Empirical

development

Systematic approach to

development

System support for development process

using scientific & empirical data

One variable at a time Multivariate experiment

Multiple variable analysis to minimize out

of specification, not average, results

Reactive lifecycle

management

Preventive lifecycle

management (and

continual improvement)

Multi-disciplinary data and collaboration

from earliest product/process concept

Figure 7: While ICH Q8 will accept the “minimal” requirements, it pushes for the QbD approach, which

digital continuity enables and extends, as it does other regulator-suggested approaches.

Product lifecycle management: Manufacturers need a

well-defined system in place to manage all phases of

product and process development, testing, and

production in an interconnected manner across the

end-to-end product lifecycle. Digital continuity supports

projects, processes, and change procedures with a

structured workflow and complete traceable record.

For biopharmaceutical companies, in particular, it is

essential to have a high performance system to

streamline the capture, analysis and reporting of

scientific information, registration and screening. This

helps to facilitate collaboration, accelerate decisions

and improve bioprocess efficiency. It is also

important to include support for planning and

execution of experiments, data analysis for queries

and visualization, configurable report templates,

capturing of sample pedigree, and data mining and

knowledge generation across the lifecycle. It also

must support the four pillars of biopharmaceutical

operations to

improve

manufacturing

process design,

planning,

monitoring, and

logistics (Figure 4).

Process Planning:

A graphical

scientific workflow

authoring tool with

a large library of

components to

easily build scientific

processes enables

manufacturers to

aggregate and gain

access to data

previously locked in

silos. Capabilities

also include the

ability to automate

the scientific data

analysis process

and rapidly explore,

visualize and report

results.

Process Monitoring: For optimal speed and

consistency, companies will capture product and

process data in-line to give a real-time view of the

manufacturing process. IT systems in production can

enforce procedures and trigger required sign-offs by

operators, supervisors, and inspectors. This can

clearly result in higher yields and more consistent

compliance to SOPs and regulatory requirements.

Supply chain management and logistics: As

ingredients are a critical foundation for product

efficacy, companies must also support sourcing,

supplier performance monitoring, and deliver digital

continuity to the supply network, including CMOs

(contract manufacturing organization). As drug

sponsors expand their use of CMOs, strong and clear

communication and collaboration is critical. Digital

continuity can provide both the access and security

required for these relationships to work effectively.




This new approach starts with

improving process

specifications to better ensure

product critical quality

attribute (CQA) outcomes

and continues through to

developing ongoing

operating requirements and

best practices. This includes

support for the information

management needs of ICH

Q8 Biopharmaceutical

Development, Q9 Quality Risk

Management, Q10 Quality

System, Q11 Development

and Manufacture of Drug

Substances and Q12 on

Biopharmaceutical Product

Lifecycle Management. Figure 8 shows the scope of

these guidelines. Such an IT system will also support

the specific needs of regulators in various markets

even beyond the EU, U.S. and Japan.

Regulators are also suggesting that using a QbD style

design space allows post approval process changes

within that envelope. An exciting, longer-term aspect

is that a digital continuity approach makes it much

easier to build results of analysis back into current

and future product and process development cycles

and tech transfer activities, as envisioned in ICH Q12.

Leveraging a common platform to support digital

continuity, biopharmaceutical manufacturers can

deploy an integrated process across the lifecycle of

the product. The comprehensive and holistic

approach required for digital continuity supports

collaboration, traceability both inside and outside of

the organization, and comprehensive understanding

of the science, processes, and product outcomes. This

will connect the teams that are ultimately responsible

for developing products, improving the manufacturing

process and the safety and quality of products.

The digital continuity platform does all of the things

mentioned above. It provides biopharmaceutical

manufacturers with the tools and methodologies

required to support a next-generation

biopharmaceutical manufacturing that reaches

beyond Operational Excellence.

Pragmatic Ways to Get Started

With digital continuity providing strategic competitive

advantages, leading biopharmaceutical

manufacturers are beginning to take notice – and

take action. Digital continuity is a large approach for

a big vision. To reap the benefits, most companies

will require new strategies, mindsets, and information

flows. This usually requires a champion with executive

level support across different domains to effect the

required changes in people, processes and

technology. What follows are some basic concepts to

help managers get each of these areas started on the

journey.

What is working

“Dassault Systèmes Solutions, including BIOVIA

Discoverant has allowed us to implement a sustainable

process monitoring plan and improve our

understanding of our manufacturing processes.”

-Systems Analyst,

Large Enterprise Pharmaceutical Company

Quotes from Survey conducted by TechValidate, May 2014

Figure 8: The ICH Guidelines cover various portions of the lifecycle, with

ICH Q12 being broad across the entire lifecycle of products.




Participate in training, education or workshops to get

your team up to speed. Public sessions relating to

regulatory guidance, operational excellence, and

some of the software to support digital continuity are

available. If only a few of your team or certain

disciplines have attended these sessions, we

recommend enrolling entire cross-disciplinary teams

in overview sessions. As teams begin to share

knowledge, they will begin to establish common

terminology and expectations.

Involve cross-disciplinary teams in designing new

processes that support a more integrated approach.

This common approach should focus on creating a

knowledge inventory, defining CQAs, reducing

variability in ingredients or in processes, formulation

scale-up, improving CPV, or simply opening lines of

communication between disciplines at critical points

in each group’s process. One typical challenging

point is tech transfer from design into production;

others may be from sponsor to CMO.

Technology that is relevant across the product

lifecycle can enable both process change and

education. It’s important to have the total digital

transformation roadmap in mind, but some

companies will start small and build out. In any case,

GMP decisions must be validation-ready. Possible

options include:

Leverage a system that supports effective

production process design with simulation and

verification of results for each product and variant

to be produced on that line.

Implement a system that helps find quantitative

and qualitative data in multiple electronic sources

quickly and efficiently to foster early collaboration

between product development and

manufacturing experts internally and externally.

Use software to deliver the data and analysis

needed to characterize and optimize the

manufacturing process. Analysis of manufacturing

operations can also identify best practices.

Use a platform approach to enforce processes,

make data more coherent and available, and

automate according to 21 CFR part 11.

A Sense of Urgency - Planning for the Future

Every company in the biopharmaceutical industry is

under increasing pressure from regulators, payers

and patients and exposed to a rapidly changing

environment. New opportunities are emerging to

serve worldwide markets and, in some cases, with

therapies targeted to smaller populations offering

improved safety and efficacy. With the resulting

complexity, biopharmaceutical companies must

develop a cross-discipline lifecycle knowledge-base

with instant information access.

Organizations are expected to deliver quality and

performance beyond what operational excellence

offers. Data-driven development and production

capabilities are required for them to reap the profits

and outcomes, handling products in ways that

regulators in each market will accept, and to satisfy

the needs of a new patient-centric market.

Other industries with human safety focus and varying

global regulations such as food, aerospace, defense,

automotive, and cosmetics have proven the value of

a digital continuity approach. Many have been able

to reduce costs, improve efficiency, and adhere to

very high quality and safety standards.

The biopharmaceutical industry is on the brink of a

new era. Outdated information management

systems that are manual or disjointed can no longer

keep up with the complexity and business pressures.

Transformation is required. Leaders are turning to

digital continuity as a more tightly integrated,

information-rich approach based on product and

process knowledge. Moving beyond operational

excellence to digital continuity will leave companies in

a better position to sustain their health and that of

their patients. At the current rate of change, this will

be a critical step for company wellness.

Iyno Advisors

Iyno Advisors combines experience, intuition, intellect, and research to focus on how manufacturing and

production companies and their network of partners can best benefit from software applications and services. www.iyno.com +1 508.362.3480

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