a technology roadmap process to … · manufacturing industry: knowledge management highlights ......

© BioPhorum Operations Group Ltd

A TECHNOLOGY ROADMAP PROCESS TO TRANSFORM THE BIOPHARMACEUTICAL

MANUFACTURING INDUSTRY: KNOWLEDGE MANAGEMENT HIGHLIGHTS

Beth Junker, BioProcess Advantage LLCAccelerating Biopharmaceutical Development

March 14, 2017


Outline

▪ Introduction to BPOG’s six phorums

▪ Description of the Technology Roadmap• Why needed?

• Collaboration

• Methodology

• Market Trends & Business Drivers

• Structure

• Outcome Summary: Vision & Benefits

▪ Technology Roadmap’s Knowledge Management Chapter • Trends, Drivers & Benefits

• Future Vision

• Use Case

• Needs, Challenges & Potential Solutions

• Outcomes

• Implementation Themes

▪ Roadmap Publication & Feedbacko Areas of Alignment/Misalignment

o Top Priorities, Preferred Sequence & Proposed Timing for Implementation

▪ Overall Summary

2


BPOG’s Six Phorums: Accelerating Biopharma’s Journey to Maturity

▪ Drug Substance, Fill Finish, Dev’t & IT Phorums

• Accelerate how industry delivers near term results,

make best practice development & implementation

faster, cheaper, smarter…

▪ Supply Partner Phorum

• Create supply chains needed by industry; define,

develop & implement solutions for business

processes, systems & culture

▪ Technology Roadmap

• Revolutionise how industry develops

transformational manufacturing &

technology capabilities

• Long term strategy & 10+yr horizon,

defining needs, challenges & solutions▪ Regulatory Interactions Group

• Engage & align with Health Authorities in design &

adoption of manufacturing advances

3

Drug Substance

Development

Fill Finish

Information Technology

TechnologyRoad Map

Supply Partner

Facilitators ensure:

• Decisions made at right time, at right place by right people

• Linkages made visible to avoid redundancy

• Synergies leveraged through effective coordination


Why is a Technology Roadmap needed?

▪ Innovation has been held back relative to other industries

• New technology often developed in isolation

• New technology often removed from new products to de-risk approval

▪ Historically new technology regulatory interactions attached to new products

• Expand opportunity to discuss regulatory challenges outside of submissions

▪ Future platforms likely very different from today’s facilities

▪ To accelerate, collaboration established to determine common needs, share them openly, then align & pool efforts to implement

• Targeted technologies not necessarily new

• Remove barriers to implementation (cultural, regulatory, timeline, quality)

4


Technology Roadmap: Bringing Industry Stakeholders Together

▪ Developed strong Steering Committee

• Required decision making

• Driving roadmap

• Subject matter experts access

▪ Diverse participants

• Manufacturers & supply partners

• Academics & regional hubs

▪ Over 160 people involved globally since June 2015

5

Manufacturers (17)

Abbvie

AstraZeneca

Bayer

Biogen

Fujifilmdb

GSK

Immunogen

Janssen

Lonza

Merck MSD

EMD Serono

Pfizer

Roche

Sanofi

Shire

Takeda

UCB

Supply Partners (12)

GE Healthcare

Thermo Fisher

MilliporeSigma

Sartorius Stedim

Kaiser Optical

PM Group

G-Con

Novasep

M+W

CRB

Pall

Asahi Kasei

Others (5+)

MIT

NIIMBL

AMBIC

CPI

SEDB


Methodology for Technology Roadmap Construction

6

Evaluate Biopharmaceutical Industry Trends

Translate trends into business drivers and metrics

Develop manufacturing & facility scenarios

Identify technology roadmap teams(value streams)

Identify technology needs, challenges & solutions

Scenarios modelled to help prioritize

areas of focus

Author, review & publish roadmap

Determine capabilities &

enablers

http://www.ifm.eng.cam.ac.ukAdapted from University of Cambridge

http://www.ifm.eng.cam.ac.uk/


Related Market Trends & Business Drivers

7

New Product ClassesNew treatment modalities

Personalized medicine

Market GrowthHigh demand

Number of drugs suppliedGlobal reach and emerging markets

Cost PressurePayer pressure on price

Biosimilars & competitionCost of clinical failure

Escalating development costs

UncertaintyClinical efficacy; Dose requirements

Product approvals, Complex regulationsDemand, competition & market share

Regional/political requirements

FlexibilityFacility design & scale

Multiproduct capabilityRegional manufacture

SpeedSpeed to clinic, build, market, supply

Cost ReductionDevelopment costs

Facility investments: TimingConstruction & validation costs

Manufacturing costs

Quality Product attributes & characterization

Comparability requirementsQuality/risk management

Cost of non-quality

Market Trends Business Drivers

Metrics for each driver


Inline

Monitoring

& Real

time

Release

Technology

Roadmap Teams

(Value Streams)

8

Process

Technologies

Modular &

mobile

Automated

FacilityKnowledge

ManagementSupplier

Partnerships

Flexibility Speed Quality Cost

New Product

Classes Cost

Pressure

Market

GrowthUncertaintyIndustry Trends

Business Drivers &

Metrics

High Level Roadmap Structure

Modelling data

& integration

Regulatory

harmonisation

Sensing

technology

Vendor

interaction

Multi-use &

flexible facilities

Technology

standards

Capable

workforce

Next gen

capabilities

Capabilities &

Enablers

Large scale stainless steel

2K scale SUS Continuous USP

2K scale SUS Batch USP

<500L scale continuous

Very low volume product,

customized to patient

Drug

Product

High volume

Drug

Product

Low volume

Scale Distributed

Manufacturing &

Facility Scenarios

Why?

How?

What?


Team Vision Example Benefits

Process Technology

Process Intensification- highly concentrated systems; combining unit operations into single units

• Low capital investment/facility size• Decreased total cost of goods

Continuous Processing - new separation & media technologies; advanced automation & process control

• Flexibility for smaller populations• Speed for process improvements

In-line Monitoring & Real-time release

Robust material characterisation, process control and assurance of product quality • Enabler of real time release

• Product released in 1-2 days• Improved product quality, operational

efficiency & reliable supply

Advanced inline monitoring devices including indirect & multi-attribute sensors

Multivariate analysis, predictive models & closed feedback control loops

Modular & Mobile

Quick to configure, assemble, scale & relocate; ‘plug & play’ standard designs & validation approaches

• Tailoring of capacity & facility mobility• Reduction in capital expenditure

Fully Automated Facility

Plug & play for fast response to capacity demands; minimal staff, changeover time & regulatoryobservations; lowest cost & highest quality from RMs receipt to final drug product

• Readily available & usable DATA• Reduced deviations & non-conformances• Streamlined real-time release

Supply Partnership Management

Partnership in spirit of openness & trust; collaborationto best use technology; integrate systems & processes

• Lower cost/higher quality for RMs, services & capex investment

• Safe, innovative supply chains

Knowledge Management

Integrated knowledge of product & process technology across development, manufacturing & commercial

• Accessible & applicable manufacturing knowledge

• Efficiency & quality thruout lifecycle

Roadmap Teams: Summary of Visions & Benefits


Knowledge Management Roadmap Team Participants

Company Team Member

AstraZenecaColeen Dixon

Eric Keller

Bayer Healthcare Ralf Laudenberg

Biogen Rob Guenard

GSK Dave Paolella

Bill Simmler

Chris Stevens

ImmunoGen Dominic Chow

Merck & CoSamantha Bruno

Paige Kane

Beth Junker (formerly)

Roche Kayhan Guceli

Sanofi Michelangelo Canzoneri

Beate Mueller-Tiemann

Shire Keith Davis

BPOG Linda Wilson10


Knowledge Management Trends, Drivers & Benefits

▪ Trends & drivers• Increasingly complex processing as supply challenges rise (ex: uninterrupted

supply, lower costs, higher regulatory & quality scrutiny) • Better understand & control complex processes • Multi-generational staff located in different bldgs, sites, time zones & countries• Data generation & volume increasing, requiring improved capability to manage &

transform it into valuable information, knowledge & wisdom

▪ Benefits exist but difficult to quantify & attribute• Speed to market, cross-product learning & efficiency thruout lifecycle

▪ Significant impact to drivers & metrics • Cost: Embedded tools for knowledge & structured lessons-learned results in

efficient processes, fewer errors & reduced costs• Speed: Well-structured & coordinated information management (‘findability’)

reduces time to release product & time to introduce process changes • Quality: Improved management of multiple knowledge formats & ‘findability’

raises process understanding, improves control & reduces OOSs

▪ Impact increases farther into 10-year horizon due to growth in knowledge generation as identified roadmap opportunities realized

11


Overall Knowledge Management Vision for 2026

▪Holistic approach to ensure that right knowledge with right people at right time to drive flow of work

▪ Knowledge treated as business asset: Capability to manage &maximize value thru creation, use & re-use

▪ Business metrics & outcomes strongly linked, then markedly improved due to better knowledge flow

▪ Core competency appropriately resourced for positive net present value & alignment with strategic objectives

▪Deliver regulatory expectations & enable full realization of guidances (ex: ICH)

▪ Product, process & technical knowledge managed at high maturity level equal to leading organizations

12


Knowledge Management Use Case Vision

13

▪What if……? • Technology transfer were efficient & right first time

• Knowledge readily available for risk assessments &control strategies

• Investigations quickly arrived at root cause

• Lessons learned reliably built back into operations

▪How would it look…..?• Process: Problem-solving processes, knowledge

feedback loops, knowledge sharing structure (ex: process & product understanding, QRM)

• Content: Standard data access, fluid taxonomies, lifecycle management for product, process & platform (including complex information)

• People: Accountability & priority for knowledge sharing

• Technology: Integrated info views across enterprise, expertise locators, reliable access to prior knowledge


Knowledge Flow Supporting Control Strategy Development

14


Knowledge Flow Supporting Process Validation

15


Knowledge Use Case: New Platform mAb Lifecycle

16

QTPP

Design Selection

Lifecycle

Management

Risk Assessment

..Design

..SpaceCQAs

Control Strategy

Product Knowledge

Process KnowledgePlatform

Platform

Industryknowledge

Industryknowledge

•Structure/function•Product characterization•Pre-clinical data•Clinical data

•Development data •Parameter / attribute models•Manufacturing data

Stage 1

Process Design

R&D Focus• Building and Capturing Process

Knowledge and Understanding

• Technical Risk Assessment

• Process Control Strategy• Develop CQAs/CPPs

Stage 2

Manufacturing• Facility Design & Qualification• Process Performance Qualification

➢ Plan, Protocol, Execution & Report

➢ Batch Scope & Number• Demonstrate Control

➢In batch & Batch to Batch➢SampleStrategy

Process Qualification

Tech Transfer

Product & Process & Platform Knowledge

Stage 3

Commercial Production• Enhanced Process Knowledge

• Redefine Sample Strategy➢Increase or Decrease

Continued Process Verification

• Lifecycle Management

• Ongoing Monitoring➢Predictive of Failure

➢Impact of Changes

➢Aging of Systems

CQA assessment: Aggregates high risk to

patient safety, but only in multimeric form

Process design: Control aggregates < 2%

Platform knowledge: Established which

steps/parameters control aggregates

Process characterization: Confirmed

relationship between parameters & aggregates

At-line monitoring: Aggregates measured vs

RM attributes & control parameters

Process control model: Developed &

transferred to clinical then manufacturing site

Documentation: Electronic central repository,

linked data sets & reports with defined taxonomy;

critical elements for manufacturing highlighted

Testing strategy: Highly capable in-line control

demonstrated & supported removal of aggregate

testing which enabled real time product release

Electronic transfer: Automation recipes,

batch records & advanced control models

Peer training: Clinical to manufacturing

Monitoring: CPPs trended & visually

assessed in real time, full access to batch

genealogy including RMs, data warehouse

easily accessible to R&D and MS&T,

standard work to assess each batch & share

info across network

RM changes: Prospectively flagged, impact

evaluated virtually & process model adjusted


Knowledge Management Use Case: ProgressionDescription: Advanced control of CQAs leading to RTR for new platform mAb manufactured at 10,000 L scale with process developed using QbDResidual risk: Very low - high product understanding (internal & external), highly controlled (automated facility, integrated monitoring, advanced analytics) & highly capable and trained workforce

KM Current Transitional State 2026

People

Process / product experts on the floor or in MS&T or Tech Ops spread across multiple shifts

-Workforce trained to create / access knowledge -Process / product expertise routinely shared

-Social networks to problem solve-Active communities of practiceKnowledge is strategic asset

Process

Reactive / trouble shooting with some process characterization into CQA & CPV parameters for unit ops

-Well characterized process parameters captured -CMAs shared with suppliers & incorporated into agreements-Standard work & tiered mtgs for knowledge sharing-Formalized peer assist, lessons learned & knowledge base

-Platform CQAs well known, referenced & enable RTR-Full lot / material genealogy on demand-Trends & events referenced against historical & industry norms

Content

Paper records withspreadsheets for analysis & reporting; lack of connection to dev’t data

Full electronic batch record integrated with statistical & CPV reports

-MVA improves process characterization-2nd gen processes defined based on prior knowledge

Technol-ogy

-Spreadsheets fed from historian usually shared via email

-People / skills finder

-EBR fed by automation, CPV data

sources integrated with LIMS

-Embedded knowledge easilycaptured & accessible-Translation of explicit knowledge into multiple languages-Industry consortium knowledge-base


Needs, Challenges and Potential Solutions

• Knowledge framework areas: process | people | content | technology

• Specific knowledge management areas• Capture & Access

• Innovation

• Product Knowledge Lifecycle and Process/Quality Control

• Platform KM

• KM Oriented Culture

• Collaboration

• Problem Solving

▪ Evaluation of Readiness for Potential Solutions

▪ Emerging Disruptive Technologies • Machine learning, mobility, integrated videos cams, natural language question answering, e-

Advisors & personalized workspaces with context-based suggestions, Internet of Things

18

Manufacturing Readiness Level

(MRL)RESEARCH DEVELOPMENT PRODUCTION


Example: Evaluation for Capture & Access

19

NEED

Current 2019 2022 2026

End-to-end solution that supports intuitive information capture & re-use

CHALLENGES 1) Today’s solutions emphasize capture of information at the time of creation

2) In addition, information is captured but without full-context (related information that helps when accessed later)

3) Too often, information saved but not re-used

4) Search focuses on Document or Text based info. In future, reference ‘data’ in addition to document knowledge at same time

5) Near-term benefit from access to “rich” info (ex: audio, video & cross-platform dashboards) to provide greater context for

referenced info

POTENTIAL

SOLUTIONSCurrent 2019 2022 2026

PEOPLE -Siloed approach to info capture

-Info access limited to ‘dept’ level

to secure info from improper

access

-Leadership embraces info as an asset

beginning to transform to future state

-Rewards to encourage info sharing &

reuse

Enterprises develop robust

knowledge stewards to

foster knowledge capture

& re-use

Knowledge

viewed as creating

competitive

advantage

PROCESS -Expertise held / recognized within

a site or department;

-Compliance / Data Integrity

ensured via procedures

-COPs emerge to pool expertise &

streamline problem solving

-Compliance/Data Integrity: Enterprise

platforms lead to fewer translation errors

-Information sharing across enterprises (thru

industry info hub) emerging

-Integrated platforms help to significantly

reduce data integrity audit findings

CONTENT Information is ‘private’ by default Information is shared openly by default Cross Industry consortiums openly exchange

non-competitive information

TECHNOL-

OGY

-Execution in paper-based systems;

manual retrieval; spreadsheets &

reports

-EBRs standard; ELNs in MS&T labs

-Lab execution systems replace paper &

log books in QC labs

Enterprise platforms integrated with ERP/Supply

Chain solutions (‘Data & Information’ platform)

ENABLERS Emerging stds for electronic

platforms enable growth &

adoption

Integrated search across text,

documents, audio & video with real-time

translation to multiple languages

“Fluid” taxonomies connect related info at time

of capture & retrieval (search, related links &

context markers)Manuf Readiness Development Development Production Production


Example: Evaluation for Capture & Access (People)

20

NEED

Current 2019 2022 2026

End-to-end solution that supports intuitive information capture & re-use. CHALLENGES 1) Today’s solutions emphasize capture of info at time of creation

2) Info captured but without full context (related info that helps when accessed later)

3) Too often, info saved but not re-used

4) Search focuses on document or text based info. In future, reference ‘data’ in

addition to document knowledge at same time

5) Near-term benefit from access to “rich” info (ex: audio, video & cross-platform

dashboards) to provide greater context for referenced infoPOTENTIAL


PEOPLE-Siloed info capture

-Info access limited to

‘dept’ level to secure

info from improper

access

-Leadership embraces info

as an asset beginning to

transform to future state

-Rewards to encourage info

sharing & reuse

Enterprises

develop robust

knowledge

stewards to foster

capture & re-use

Knowledge

viewed as

creating

competitive

advantage

Manuf

Readiness

Development Development Production Production


Example: Evaluation for Lifecycle & Process/Quality Control

21

Current 2019 2022 2026

Metric Baseline: Development cost 25% reduction 35% reduction 50% reduction

Metric Baseline: Cost of non-quality 20% of operating costs 10% of operating costs 2% of operating costs

NEED KM systems that flow from early product development through lifecycle; understanding facilitated by analytics advances --advanced process control from enhanced knowledge framework which improves quality & control

CHALLENGES 1) Complexity of evolution from current state to optimized flow of knowledge for contextualization

2) Lack of systems integration to allow for effective data capture and multivariate analysis/modeling

3) Cultural barriers to enabling knowledge flow across lifecycle

4) Advanced analytics tied to CQA understanding require focused cross-functional efforts

5) Connecting flow of knowledge from end to end lifecycle/patient impact to earliest stages of development

POTENTIAL SOLUTIONS Current 2019 2022 2026

PEOPLE: Up-skilling on

data contextualization

and knowledge sharing

Cultural barriers to enabling

knowledge flow across the

lifecycle

-Understanding of knowledge

& org structure E2E needs

-Knowledge flow sponsorship

-Staff have KM as part of

job requirements in linked

fashion

KM infrastructure with

metrics/incentives to

sustain/improve

PROCESS: QbD

embedded in early

stages, flowing to filings

& into lifecycle

-Investment in understanding

during late stage

-Std or enhanced strategies

developed prior to filing

-Product-specific CQA

understanding

-Knowledge-based risk

assessments flow to filings

-Routinely reuse platform

data & understanding

-Portal to facilitate lifecycle

advances (Q12 world)

Industry database leveraged

for regulatory submissions

CONTENT: CQAs & CPPs

defined & managed real

time

Links among CMAs, CPPs &

CQAs managed ad-hoc

Knowledge linking RMs,

process controls, and

attributes

Systems integrated –CQAs

& CPPs in informatics

toolkit

Predictive control based on

informatics; managed real

time

TECHNOLOGY: Digital

flow of understanding

over time (context)

Few & immature software

choices for capture & context

Tool to design processes,

experiments & context

Holistic E2E tool integrating

pilot & commercial data

Reg docs pre-populated &

integrated with QMS

TECHNOLOGY: Adaptive

control systems

PAT not in routine usage for

DS manufacturing

CQA understanding linked to

adaptive control for 10% of

CQAs; reduced testing

CQA understanding linked

to adaptive control for 25%

of CQAs; reduced testing

CQA understanding linked

to adaptive control for 50%

of CQAs; reduced testing

TECHNOLOGY: MVA

based on process models

MVA used in limited capacity

in retrospective fashion

Prospective models routinely

linking parameters & QA

Prospective models include

RM attributes

Predictive control & process

reliability thru modeling


Example: Evaluation for Lifecycle & Process/Quality Control

22

Current 2019 2022 2026

Metric Baseline: Dev’t cost 25% reduction 35% reduction 50% reduction

Metric Baseline: Cost of

non-quality

20% of operating

costs

10% of operating

costs

2% of operating costs

NEED KM systems that flow from early development thru lifecycle; understanding facilitated by analytics advances -- advanced control from enhanced knowledge framework which improves quality

CHALLENGES 1) Complex evolution from current state to optimized flow of knowledge for

contextualization

2) Lack of systems integration permitting effective data capture & MVA/modeling

3) Cultural barriers to enabling knowledge flow across lifecycle

4) Advanced analytics tied to CQA understanding require cross-functional efforts

5) Connecting flow of knowledge from E2E lifecycle/patient impact to early dev’t

POTENTIAL


TECHNOLOGY:

Adaptive

control

systems

PAT not in routine

usage for drug

substance

manufacturing

CQA understanding

linked to adaptive

control for 10% of

CQAs; reduced

testing

CQA understanding

linked to adaptive

control for 25% of

CQAs; reduced

testing

CQA understanding

linked to adaptive

control for 50% of

CQAs; reduced

testing


▪ Vision & Framework: process | people | content | technology

▪ Use case developed to illustrate concepts

• Use of knowledge (CPPs impact on CQAs) to develop controls that maximize quality

▪ Focus on needs, challenges, and potential solutions

• KM generally enables all scenarios (ex: many small batches & multi-product & multi-facility)

• Significant cost, speed & quality impacts

o Interestingly, no significant impact on flexibility (driven by strong business & technical considerations)

▪ Notable linkages identified for alignment

• Supplier Partner roadmap team

o Seamless & secure (cloud-based) sharing of standardized supplier databases (genealogy,

investigations, risk mgmt, change notification)

o Sufficient protection of IK/IP during collaborative development & testing of novel technologies

• In-line monitoring/Real-time release roadmap team

o Predicated on strong process/product understanding & controls (QbD)

o Gather & convey required knowledge to enable registration & site support

• Information Technology phorum: IT platforms & their scope/priority

▪ Recommendations

• Advance IT (tools & systems) to support real-time & networked KM systems

• Incentivize & motivate strong KM systems (within company & thruout industry)23

Knowledge Management Roadmap Outcomes


Knowledge Management Implementation Themes

▪ KM is conscious effort that must include strategy & implementation roadmap, resources and strong sponsorship

▪ Clear strategy avoids slow starts & reduces skepticism

• Pre-requisite to assess current state & benefits

▪ Embed KM in business & solve real business problems to gain momentum

• Crucial capability to preserve & grow knowledge (organization’s most valuable asset)

• Minimize theoretical or abstract concepts

• Pragmatic & easy-to-follow common sense approach

▪ Equal attention to People, Process, Content & Technology

• Right technology crucial but not sufficient

• Knowledge management not equal to information management

• Systematic approach & cultural readiness

▪ Sufficient leadership commitment & sponsorship breaks through roadblocks

• Clear ties to organization’s success measures (enable the business)

• Dedicated measures for KM deployment & maturity

• Right focus in right areas first (sufficient resources)

▪ Implementation takes cultural transformation

• Change management activity requiring patience to build core competencies

• Engage all critical stakeholders to realize maximum potential

24


Roadmap: Publication, communications & feedback

▪ 1st edition published in May 2017, freely available • http://www.biophorum.com/category/resources/technology-roadmapping-

resources/roadmap/

▪ Complemented by broad communications mix• Webinars, conference presentations, articles, newsletters

▪ Request input on roadmap’s content & future scope• Individual comments or formal response from your organisation

• Your organisation becoming active members of the collaboration

▪ Roadmap is about stimulating an industry response, encouraging required innovation to happen

▪ What solutions can you bring to overcome difficult challenges facing the industry?

25

Communications

2016 2017 2018

Articles & conferences Articles & conferences

Publish 1st EditionMay’17

BIO

Engagement & feedback

Publish 2nd

Edition

BPOG Website

Conference presentations

http://www.biophorum.com/category/resources/technology-roadmapping-resources/roadmap/


Overall summary

▪Strong Technology Roadmap collaboration well established• Biomanufacturers, suppliers, regulators, academics, regional hubs

▪Solid business benefits identified • Unified industry needs to align efforts across stakeholders

• Substantially change risk-reward profile of new technology development

▪ Integrated teams built close partnerships • Pooled effort on pre-competitive potential solutions

• Enable fast adoption (ex: identify rapid prototyping opportunities)

▪2017 provides opportunities to accelerate change together!• Receive & incorporate feedback into 2nd editionoDeeper dives into critical areas & extend to adjacent areas not covered

• Achieve rapid development & demonstration of new technologies

o Influence required fundamental R&D efforts

• Use combined knowledge & experience to address identified regulatory challenges

26


Roadmap Intended Use Statement

▪This roadmap report is created and intended in good faith as an industry assessment and guideline only, without regard to any particular commercial applications, individual products, equipment, and/or materials.

▪Our hope is that it presents areas of opportunity for potential solutions facing the industry and encourages innovation and research and development for the Biopharma industry community to continue to evolve successfully to serve our future patient populations.

27


BACK UP

28


Submitted Abstract

What prompts over 100 biopharmaceutical manufacturers, leading academics, supply partner R&D heads, regulators, and worldwide regional hubs to get involved in a major project? It’s when that project identifies the future technology needs of the biopharmaceutical manufacturing industry and accelerates its collective innovation.

The complexity of the current industry structure has held back innovation, with many biomanufacturerstrying to develop new technology in isolation, whilst supply partners have to often guess the common industry requirements. Over the last two years, BioPhorum Operations Group’s (BPOG’s) technology roadmapping collaboration has brought together 26 of the biopharmaceutical industry’s top manufacturing and supplier companies, along with leading academics, to establish an industry-wide technology strategy that is already starting to align the industry’s innovation efforts.

To reach this point, a strong steering committee was established with a shared vision of the future of biomanufacturing, a vision that was responsive to the market trends such as lower cost, in-region manufacturing and flexible capacity. The drivers and metrics from this shared vision triggered the mobilisation of over 90 industry experts onto six roadmap teams focused on the key enabling technologies of in-line monitoring & real-time release, process technology, automation, modular & mobile, knowledge management and supplier partnerships. Each team has now established detailed technology roadmaps that, when combined, provide a technology roadmap for the next 10 years for the global biotech industry. This roadmap will be subsequently freely published to enable broad dissemination and a wider industry response.

This presentation describes highlights from the roadmap in the form of future capability needs, challenges and solutions, with an emphasis on the knowledge management team outcomes and associated interdependencies with the outcomes of the other six teams. The first publication of the roadmap will be just the beginning; like every strategy it will be refreshed and updated regularly. Input and comments are being solicited now and after publication in May 2017. Post-publication, BPOG will be facilitating and tracking the industry’s progress towards the future vision.

29


Standard Workflow for Product Development Lifecycle –Clinical/Development Phase

30


Standard Workflow for Product Development Lifecycle –Commercial Phase

31


Example of Framework Need: Building a Map to Assess Knowledge Flow (Process)

32


People, Process, Content & Technologies

33


Regulatory Summary of Needs, Challenges, Potential Solutions –KM

34

Technology Roadmap Team Regulatory Needs and Challenges ConsiderationsKnowledge Management KM) Expectations on Compliance activities

Expectations on Implementation of ICH Q10 Data Integrity expectations for product and facility lifecycleTraining expectations: workforce, facility, production characteristics

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