A Global Technology Roadmap for Biopharmaceutical Manufacturing… · 2018-11-11 · A Global Technology Roadmap for Biopharmaceutical Manufacturing: An Update from BPOG Presentation

Technology Roadmapping © BioPhorum Operations Group Ltd© BioPhorum Operations Group Ltd

A Global Technology Roadmap for Biopharmaceutical Manufacturing: An Update from BPOG

Presentation to Bioprocess International (BPI)Boston, MA 2016Bert Frohlich, Thomas Ryll

5th October 2016


Agenda

▪Who is BPOG

▪What is a Technology Road Map:Introduction to the Biopharmaceutical Industry Collaboration

▪Why a Road Map is needed. Why now…

▪How is the Map Created: The Methodology

▪Now!: Overview of key roadmap content to dateoMarket trends & business driversoBiomanufacturing scenariosoInitial process modelling results

▪When: Next Steps

27/6/2017


Who is BioPhorum Operations Group (BPOG)Industry collaboration that brings together 33 bio-manufacturers, collaborating in six phorums to accelerate the industry

7/6/2017 3


6 Phorums covering all aspects of operations and accelerating biopharma industry’s journey to maturity

4

Drug Substance

DevelopmentGroup

Fill Finish Information Technology

TechnologyRoad Map

Supply Partner Phorum

7/6/2017

http://www.biophorum.com/

http://www.biophorum.com/accelerate




Agenda

▪Who is BPOG





▪When: Next Steps

57/6/2017


What is a Technology Road Map?!

An industry technology roadmap is –

a dynamic and evolving collaborative technology management process

For:

7/6/2017 6

▪determining precompetitive critical needs and drivers,

▪ identifying technology and/or manufacturing targets, and

▪assessing/modeling potential solutions


Agenda

▪Who is BPOG





▪When: Next Steps

77/6/2017


Why is a Technology Roadmap needed for the Biopharm Industry?

▪ Complex global regulatory environment• Multiple jurisdictions

• Varying requirements

▪ Biomanufacturers are risk averse • The penalties are severe for delays and setbacks in drug commercialization

• Uncertainty around product comparability between scales and process changes

• New technology may not be adapted because of perceived risks to program

• Everyone wants to be a Fast Second!

▪ Biomanufacturers and Suppliers develop technologies in isolation

▪ Technology standardisation usually only occurs after the technology is launched

▪ Suppliers find it difficult to innovate • Have to guess end user requirements

• Risk-reward balance is poor

Technology Roadmapping 8

Complex industry has traditionally held back innovation….


Audacious goal:

▪ Focus the industry on longer term strategy & 10+yr time horizon

▪ provide direction, and

▪ defining needs, difficult challenges and potential solutions

▪ resolve those critical needs

7/6/2017 9

Revolutionise the way the industry develops longer term

transformational manufacturing and technology capabilities

,

To agree an industry technology strategy


Why is this approach different this time?

▪More collaborative cross-company/institution approach

▪ To include all stakeholders…

7/6/2017

10

May 2016

BioManufacturers

Suppliers

BioManufacturers

Regulators

Academia

Suppliers

• Cultural and Behavioral

• Regulations and compliance

▪ Longer-term view (we’re all better off in the long run if we work together…)

▪ Addressing barriers to implementation:

Academia

Regulators

BEFORE AFTER

• Commercialization timeline risks

• Product comparability risk


Agenda

▪Who is BPOG





▪When: Next Steps

117/6/2017

Technology Roadmapping © BioPhorum Operations Group Ltd

Following the Lead from other Industries…..Using method from University of Cambridge’s Institute of Manufacturing

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Semiconductor Industry

NASA


Technology Roadmapping Steering Committee

▪ Developed a strong Steering Committee

• Required decision making

• Driving roadmap

• Subject matter experts access

▪ Diverse participants

• 17 biomanufacturers

• 6 supply partners recently joined (and growing)

• Academics & regional centres, e.g. MIT, AMBIC, CPI, SEDB, NIIMBL

▪ Over 130 people involved globally

13

CompanyAbbvieAstraZenecaBayerBiogenFujifilmdbGSKImmunogenJanssenLonzaLillyMerck MSDEMD SeronoPfizerRocheSanofiShireTakeda

7/6/2017


Overview of Methodology for Technology Roadmap Construction

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Evaluate Biopharmaceutical Market Trends

Identify Main Business Drivers & Metrics

Identify/prioritize Advantages / disadvantages

Develop Representative Scenarios

Identify/prioritize Opportunities for Improvement

Model Facility TypesFix: Process/Facility Type

Vary: Throughput, utilization, product mix

Identify Potential Solutions and Alternatives

Define Development Timelines and Pathways

Technology Roadmap

Define Scenario/Options Matrix and Objectives

Business Scenarios (Key Drivers)

vs.

Biomanufacturing Facility Type Scenarios (Options)

Define

Objectives

Model Business ScenariosFix: Throughput, Product mixVary: Process/facility design

1

3

5

2

4



Model

Analyze

Plan

6

7

8


Agenda

▪Who is BPOG





▪When: Next Steps

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Evaluating Biopharmaceutical Market Trends (Step 1)

16Feb 2016Technology Roadmapping

Robust

Pipelines

Biosimilars

Competition

Diversification

of product

groups

Payer

pressure on

cost of drugsIn-region

manufacturing

requirements

Personalised

medicine

Complex Global

regulatory

environment

Strength of

Sales (Biologics)New

Treatment

Modalities

Emerging

Markets

Social / Political

Perceptions

Clinical FailuresDose

Requirements

Market

Share

Demand

Forecasts

Rising Costs

of Drug

Development

Advances

in Systems

Biology


Collective Brainstorming by Industry Experts

Technology Roadmapping May 2016 17


Defining Main Business Drivers and High Level Roadmap Structure (Step 2)

Technology Roadmapping Update

Speed Cost Flexibility Quality

Diversification

of product

groups

Payer pressure

on costIn region

manufacturing

Personalised

medicine

Real time

Release

Industry Trends

Technology Areas

Enablers(Examples)

June 2016 18

Modular and mobile

Knowledge management

Process intensification

Continuous processing

Automation

Inline monitoring

Technology

standards

Vendor

interaction

Supplier

Management

Regulatory Harmonisation

Keep

workforce

capable

Multi-use and

flexible

facilities

Business Drivers


Developing Representative Scenarios (Step 3)

▪Purpose of Business Scenarios

• To help evaluate biomanufacturing strategies and technologies that will have greatest impact for a particular set of business drivers

• Not all companies have the same set of ‘Key’ business drivers or metrics

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▪Purpose of Biomanufacturing / Facility Type Scenarios and Options

• Represent today’s typical facilities (current state-of-art)

• Many companies have existing assets that need to be utilized and even potentially expanded

• Serve as starting point for technology road map


Defining Objectives and Options for Modeling (Step 4)

▪ Purpose of Modeling

• Identify areas of opportunity for improvement within a given scenario / facility type.

• Compare performance between options within a scenario or between scenarios relative to a given metric

o e.g. compare estimated Cost of Goods using different process formats

• Process parameter sensitivity analysis

• Identify bottlenecks in throughput and breakpoints in technology strategy/selection.

• To evaluate the technology improvements proposed by the roadmap teams

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▪ Limitations of Current Models

• Performance estimates are not absolute. Models are not calibrated to any specific circumstance such as location or specific organizational context

• For relative comparisons only; Default values for base line comparison (e.g. price of raw material costs, equipment and labor, installation factors

▪ Excluded

• Site purchase, staffing cost and raw materials & consumables up to production

• Central development labs and site offices

• Site warehousing

• Black utilities


Processing Options (and Symbols)

217/6/2017

Stainless Steel (SS)

(Conventional)

Single-use(SU)

(Disposable)

Upstream Process

(Bioreactors)

Downstream Process

(Purification Train)

Batch

(Fed-batch)

Continuous

(Perfusion)

Batch Continuous

Hybrid(SS+SU

(Volume

dependent))


Modeling Cases

227/6/2017

SS-B / B

SU-B / C

High-demand Product

(High Volume)

SU-C / B

10,000 kg/yr 1,000 100 10 1 0.1

Low-demand Product

(Low Volume)

Design

SU-B / B

SU-C / C

SS-B / C


Process Modeling – Biopharm Services using BioSolve Software

237/6/2017

▪ Initial modelling done using a platform mAb process• Targeting 1,000 or 100 kg per year output

• Using 12.5kL SS or 2kL SUB reactor and combinations of B/B, B/C, C/B and C/C processing

• Capital Investment and COG

• Parameter sensitivity analysis

Batch Downstream example


Overview of modeling 1,000 kg and 100 kg output per year

▪ Next round of modeling will float output assuming more realistic facility designs (“6-pack” facilities)

▪ Initial exercise already useful in pointing to opportunity areas

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9 month duration

1,800 L 600 L


Modelling 1,000 kg/year Output

▪ Continuous downstream processing reduces COG

▪ Continuous upstream processing has no cost benefit over batch

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Net Present Cost: Scaling up vs. Scaling Out….

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Conventional

“Six-pack”

Facility

6 x 15,000L Stainless Steel

Bioreactors

Expanded or

Multi-Facility

6 x 2,000L Single-use

Bioreactors

Total Facility Output (kg/yr)


Batch versus Continuous, 1,000 kg using 2,000L scale

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A few Results of the Initial Process Parameter Sensitivity Analysis

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▪Upstream and Downstream Yields are major cost drivers

0

20

40

60

80

100

120

140

0 5 10 15 20

CO

G (

$/g

)

Titer (g/L)

12.5k B/B

12.5k B/C

2k B/B

2k B/C

0

20

40

60

80

100

120

140

60 70 80 90 100

CO

G (

$/g

)

% Yield

ProA Yield

Polishing Yield

ProA Yield 100kg

Polishing Yield 100 kg

100 kg/year

1,000 kg/year

Cell Culture Yield Downstream Recovery


Interaction between Perfusion Rate and Cell Concentration and Productivity

▪ Cell specific perfusion rate and perfusion media costs are major cost driver

▪ If cell specific perfusion rate is increased, higher cell mass and higher specific productivity is required to maintain cost

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Initial Flags for Technology Opportunities

▪Upstream batch titer• Perfusion applications to batch culture• Culture duration

▪High downstream step yields• Purity and impurity profiles (simple and robust product modalities)• Resin features (capacity and impurity clearance)

▪ Perfusion media costs and specific perfusion rate• Media design and waste product formation• Highly concentrated and balanced media of low cost

▪ Consumables cost • Improved filter capacity and production processes

▪ Buffer production strategy• Buffer concentrates and in-line dilution

▪ Production cell lines• Cell specific productivity• Impurities and product quality features (glycans)• Harmonized expression system

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Conclusions and Next steps

▪Significant progress has been made in bringing the industry together for this precompetitive collaboration

▪A work in progress, More work to be done

▪Will take some time and a few iterations. First time this is being done with wide industry participation

▪Vendor and academic partner participation

▪Technology innovation opportunities are beginning to be identified

▪More modeling to be done to help assess value and prioritize

▪Plan to publish completed road map before mid of 2017

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Acknowledgements

▪Andrew Sinclair

▪Alan Calleja

▪Paul Ilott

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Disclaimer

▪This presentation was prepared by the BPOG Consortium. The opinions and views expressed are from the BPOG Consortium and do not reflect the views of individual member companies

337/6/2017

Thank You!


Anti-Trust Compliance Statement v4.0

▪ It is the clear policy of BioPhorum that Biophorum and its members will comply with all relevant anti-trust laws in all relevant jurisdictions

▪ All BioPhorum meetings and activities shall be conducted to strictly abide by all applicable antitrust laws. Meetings attended by BioPhorum members are not to be used to discuss prices, promotions, refusals to deal, boycotts, terms and conditions of sale, market assignments, confidential business plans or other subjects that could restrain competition.

▪ Anti-trust violations may be alleged on the basis of the mere appearance of unlawful activity. For example, discussion of a sensitive topic, such as price, followed by parallel action by those involved or present at the discussion, may be sufficient to infer price-fixing activity and thus lead to investigations by the relevant authorities..

▪ Criminal prosecution by federal or state authorities is a very real possibility for violations of the antitrust laws. Imprisonment, fines or treble damages may ensue. BioPhorum, its members and guests must conduct themselves in a manner that avoids even the perception or slightest suspicion that antitrust laws are being violated. Whenever uncertainty exists as to the legality of conduct, obtain legal advice. If, during any meeting, you are uncomfortable with or questions arise regarding the direction of a discussion, stop the discussion, excuse yourself and then promptly consult with counsel..

▪ The antitrust laws do not prohibit all meetings and discussions between competitors, especially when the purpose is to strengthen competition and improve the working and efficiency of the marketplace. It is in this spirit that the BioPhorum conducts its meetings and conferences.

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▪Back-Up Slides

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Modelling 100 kg/year Output

▪ Continuous downstream processing reduces COG

▪ Continuous upstream processing has no cost benefit over batch

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Could go out


Batch versus Continuous

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Roadmap plan through to publication

2016 2017

A M J J A S O N D J F M A M J

Face to face meetings

Review points

Steering committee contribution

Roadmap Team (RT) activity

Industry stakeholder engagement

Communications

Final approvals

TR03 – Roadmap team meeting (12-14 Apr’16)

TR04 – Finalising the roadmap (20-22

Sep’16)

TR05 – Implementation planning and Industry

Response

BPI article

1. Summary document

review

2. Detail document

review

Freeze document Publish

Roadmap revision 2Support / co-ordinate

implementation

SummaryVision, Map,

Scope, Linkages

DetailNeeds,

Challenges, Solutions

OverviewMarket Trends, Product Classes,

Business Drivers, Scenarios, Modelling

Final modifications and

input from industry

stakeholders

Implementation planning and

industry responseChallenges, Solutions

Revie

w t

o c

larify

focu

s,

linkages

& s

pot

gaps

Pre

para

tion for

TR04. Lis

t to

p p

oin

ts t

o

add v

alu

e, is

sues,

debating p

oin

ts

Det

ail r

evie

w f

ollo

we

d b

y fi

nal

ch

ange

s to

do

cum

ent

7/6/2017

38

BPI article

BPI article

BPI conference


6 Phorums covering all aspects of operations and accelerating biopharma industry’s journey to maturity

▪ Drug Substance, Fill Finish, Development

Group and IT Phorums

• Accelerate the way the industry delivers near term

results making best practice development and

implementation faster, cheaper and smarter

▪ Supply Partner Phorum

• Strategic focus on the wider supply chain needs of the

industry; defining, developing & implementing

solutions

• Focus on business processes/systems & culture

The focus for this presentation▪ Technology Roadmapping

• Revolutionise the way the industry develops

longer term transformational manufacturing

and technology capabilities

• Focus on longer term strategy & 10+yr time

horizon, defining needs, difficult challenges

and potential solutions

▪ Regulatory Interactions Group

• Engage and align with Health Agencies in the

design and adoption of advances in

manufacturing

39

Drug Substance

DevelopmentGroup

Fill Finish

Information Technology

TechnologyRoad Map

Supply Partner Phorum

BPOG manages the linkages to ensure

• Decisions are made at the right time, at the right place by the

right people

• Linkages are made visible to avoid redundancy

• Synergies are leveraged through effective coordination

7/6/2017






Business drivers

Driver Metric Description 5 yr Target 10 yr Target

Cost Total cost to supply COGs - Labour, materials, utilities, variable costs, delivery rejects. $50/gm (mAbs) $10/gm (mAbs)

Reduction of total cost to supply from 2015 values 50% 90%

Cost of upfront investment in manufacturing

Total capital cost of facility to supply 1,000,000 doses / year$100M DS facility$50M DP facility

$50m DS facility$25M DP facility

Cost of developmentStart of phase 3 process analytical formulation development to launch (1st major market approval) - reduction from 2015 levels

25% 75%

SpeedTime to make product (End to end speed)

Time from initiating Drug Substance Production (vial thaw) to completing Drug Product Production

2 months 1 month

Time from initiating Drug Substance Production (vial thaw) to completing DP Production - reduction from 2015 levels

50% 75%

Time to release product (End to end speed)

Time from completion of Drug Product production to full release of Drug Product

2 weeks 1 day

Time to produce first GMP material for the clinic

Time from DNA (molecule selection) to material available to clinic 12 months 8 months

Speed to market Time from release of phase 1 material to launch 5 years 3 years

Time to introduce a change to an existing process

Time to introduce a process change (specifically new DS site, new resin, etc)

2 months 1 month

Time to introduce a process change (eg new DS site, new resin, etc) 18 months 6 months

Facility build speed Time from build decision to ready for first PPQ batch 2 years 1 year

Flexibility Number of platforms per suite The ability to change to different platforms (eg, CHO, E. coli, yeast, gene therapy) within a suite.

3 >5

Titer Range in upstream that is directly accommodated by downstream facility fit

The ability to manage higher and wider titer ranges in both fed-batch (FB) and perfusion (P).

FB: 1 – 10g/LP: 0.5 - 5g/L/day

FB: 2 -40g/LP: 0.5 - 10g/L/day

Facility production per unit time -Utilization percentage

Time facility in use for production (rather than product changeover, cleaning, shutdown / maintenance)

>85% >95%

Quality Cost of Non-QualityDiscard rate, investigation resources. Batch record rework. Includes RMs

10% of operating costs 2% of operating costs

Assay qualityProcess Variability

Measure of process reliability.PPK for assay for all measures (release tests, CQAs, CPPs)

>1.5 >1.8

Product availability Inventory level50% reduction

2 months90% reduction

2 weeks

March 2016Technology Roadmapping 40


Map as a Guide to Execution

417/6/2017



Define Unions and Decision Points

Performance Metrics

Achieved?

Technology Roadmap

Direct / Recommend Collective Resource Distribution

Monitor and Redirect

• Collective Resourcing

• Collaborative Funding

• Supplier-based Funding

• Academic Collaborations

• Crowd Sourcing

Benefit Realized

Initial Roadmap


Roadmap Teams, comprising experts from across the bio-pharmaceutical companies, have been formed to define the detailed technology needs, challenges and solutions to deliver the bio-manufacturing vision

42

Roadmap Team Vision

Process Technology

Process Intensification: Intensifying production through highly concentrated reactants and products and combining unit operations into single units.

Continuous Processing: New separation and media technologies, coupled with advanced automation and process control.

In-line Monitoring and Real-time release

Process control and assurance of product quality through advanced monitoring devices, in-direct or multi-attribute sensors and PAT.

Global regulatory testing standards, advanced process control strategies and raw material characterization.

Modular and Mobile

Manufacturing systems that are quick to configure and assemble using ‘plug and play’standard designs.

Fully Automated Facility

Scale up from development to manufacturing, with a focus on automation, equipment, and biology, results in a fully automated facility.

Supplier Management

Suppliers become technology development partners for our industry, collaborating to solve problems.

Knowledge Management

Integrated knowledge of product and process technology across the development, manufacturing and commercial value streams.

7/6/2017


Process Technology - Scenario Needs (1 of 2): (Draft - Illustrative)

437/6/2017

Unit Operation Scenario 1 Scenario 2 Scenario 3 Scenario 4A Scenario 4BD

esc

rip

tio

nBioreactor Volume SS >10kL BXRs Disposable 2kL BXRs Disposable 2kL BXRs Disposable <500 BXRs Disposable <500 BXRs

Bioreactor Mode Batch Continuous1 Batch2 Continuous1 Batch/Continuous

DSP Mode Batch/Continuous Semi-continuous/

Continuous

Batch/Semi-continuous Continuous Batch/Continuous

Facility Design Segregated suites/

Large footprint

Moderate footprint/

Ballroom

Moderate footprint/

Ballroom

Small

footprint/Ballroom

Small

footprint/Ballroom

Processing Low Bioburden Closed Closed Closed Closed

Product mAb and other CHO

TPs

mAb and other CHO

TPs

mAb and other CHO

TPs

mAb and other CHO

TPs

Cell/Gene Therapy

Comment Adaptions on current

facility

designs/retrofits

Continuous protein

production through

purification

High titer batch USP

processes to match

productivity of 10kL

BXRs

Highly productive

deployable facilities

Deployed at point-of-

use

Up

stre

am

Inoculum Preparation Cryobags to reduce

time to production /

N-1 Perfusion

Cryobags to reduce

time to production

Cryobags to reduce


N-1 Perfusion

Cryobags to reduce


N-1 Perfusion

Production Cell

Culture

Cell Density >15MM cells/mL >60MM cells/mL >60MM cells/mL >60MM cells/mL

qp >40pg/cell/day >40pg/cell/day >40pg/cell/day >40pg/cell/day

Titer/ Productivity 3-5g/L 2-3g/(L·day) 30-50g/L 3-6 g/(L·day)

Product Quality Consistant throughout batch duration

Media Media Defined/Stable / Low

cost

Defined / Stable /

Balanced / Low cost

Defined / Stable /

Balanced

Defined / Stable /

Balanced / Low cost

Viral Safety HTST or low cost viral

filter

Disposable HTST / low

cost viral filter


cost viral filter


cost viral filter

Cell Retention N-1 Microfiltration Disposable filtration

(non-fouling) /

Acoustic wave

Disposable filtration /

Acoustic wave

disposable filtration

(non-fouling) /

Acoustic wave

Bioreactor Design Reactor Design Easily cleanable / Rapid

Changeover

Long duration, robust

films and seals

Robust films Long duration, robust

films and seals

Polymers New elastomers not

requiring replacement

Defined and repeatable

E&L profiles


E&L profiles


E&L profiles

Sensors Multi-function; Increased robustness (e.g. SU glucose, lactate, cell mass, pCO2 etc.)

Har

vest

Harvest Primary Recovery Disc-stack

centrifugation /

Flocculation / Acoustic

wave /

Disposable

Centrifugation

See cell retention

above

Flocculation / Cell

Settling /

Microfiltration /

Acoustic wave /

Disposable

centrifugation

See cell retention

above

Clarification Re-usable depth

filtration

Gamma compatible

depth filtration

Re-usable depth

filtration

Gamma compatible

depth filtration


Process Technology - Scenario Needs (2 of 2): (Draft - Illustrative)

447/6/2017

Pu

rifi

cati

on

Viral Clearance Detergent / Solvent

Virus InactivationNovel sewerable detergent

Primary Purification

(eg affinity chromatography)

• Resin cross-use• Ultra-high capacity • SS Continuous

Chromatography (eg GE PCC)

• Infinite lifetime adsorbents

• Disposable Continuous Chromatography (egPall BioSMB)

• Resin Cross-use• Ultra-high capacity• Infinite lifetime

adsorbents

• Resin Cross-use• Ultra-high capacity• Continuous

Chromatography• Infinite lifetime

adsorbents

• Disposable Continuous Chromatography (egPall BioSMB)

• Resin Cross-use• Ultra-high capacity• Infinite lifetime

adsorbents

Viral Clearance pH Viral Inactivation Modular claim • Low pH, short time• Modular claim

Modular claim • Low pH, short time• Modular claim

Secondary Purification 1 & 2 • Novel chromatography materials (Flow through or bind & elute)• Universal negative chromatography ligands (HCP/DNA scavengers)• High capacity membrane adsorbers (Flow through and bind & elute)• Low holdup scalable membrane devices for membrane adsorbers

Viral Clearance Viral Filtration • High capacity – re-usable viral filters• Absolute virus rating to streamline virus safety

Ultra-filtration /

Dia-filtration

Ultrafiltration Membrane cross use

Increased membrane

lifetime

• Membrane cross use

• Robust single pass TFF

Membrane cross use

Increased membrane

lifetime

• Membrane cross use

• Robust single pass TFF

Diafiltration Single-Pass Diafiltration High area disposable TFF Single-Pass Diafiltration

Buffer Management • Buffer on Demand• Buffer Dilution• Novel: Inprocess DSP Formulations

• Buffer consolidation• Increased column binding capacity

USP

+ D

SP

Novel Technologies • Affinity Partitioning• In-Situ Capture• Expanded Bed

Adsorption• High resolution

product related impurity separations

• Continuous Crystallization

• High resolution product related impurity separations

• Novel cell retention devices

• Aqueous 2 phase separation

• Protein Crystallization• Affinity Partitioning• In-Situ Capture• Expanded Bed

Adsorption• High resolution

product related impurity separations


• Continuous Crystallization

• High resolution product related impurity separations


General Needs • Cross-use of consumables among different molecules• Enhanced PAT tools• Advanced process control (eg. Multivariate statistical process monitoring

with feedback adaptive control)

• Rapid methods for column lifetime and cleaning studies\

• Standardization of connectors (both traditioanal and aseptic)

• Simplified viral clearance validation


Inline Monitoring and Real-time Release: (Draft - Illustrative)

457/6/2017


Modular & Mobile: (Draft - Illustrative)

467/6/2017


Automated Facility: (Draft - Illustrative)

▪Full integration across all systems

▪ In-line, real time monitoring

▪Management of data

▪High availability automation systems

▪Reduction of manual labour through the use of robotic systems

▪New technologies and inclusion of robotics

477/6/2017


Knowledge Management: (Draft - Illustrative)

487/6/2017


Supply Partner Management: (Draft - Illustrative)

▪Openness & Trust

▪EDE & Supplier Integration

▪Standardisation

▪Quality Built-in

▪Forecasting & Demand Planning

497/6/2017


Regulatory Interaction: Regulatory Engagement Plans

Target Objective Contact Timing Achievements / Next Steps

FDA CDER ETT

• Introduce BPOG and plans for Technology Roadmap• Request Industry Meeting as part of TR Implementation• Involve in TR Meetings (e.g. TR04)

Dr Sau (Larry) Lee, FDA

Q4, 2016 • Introductory TCs• Sent TR update• Agreed principle of an Industry Meeting with ETT

FDA CDER OPQ OBP

• Introduce BPOG and TR•Provide education session for Reviewers• Invite to attend TR04

Chikako Torigoe, FDA

26th

September 2016

• Introductory TCs and discussed potential topics• Sent TR update and discussed specifics• Education Session 26th September 2016

MHRA Strategy & Innovation

• Introduce BPOG and TR• Determine potential of joint interest• Agree further meetings

Ian Rees,MHRA

Q4, 2016 • Sent BPOG W/S and TR update• Met F2F in March 2016• Agreed to hold Periodic Review

ANVISA • Industry Meeting to address issues with long approval lead-times• Identify other opportunities towork together

PAS (Robin), BPOG

2nd August 2016

• PAS/ANVISA Meeting held 2nd August 2016• Further engagement agreed (e.g. Workshops)• Opens updebate on next LATAM country

FDA • Education Session of PAT for Lyo PAT for Lyo(Dawood), BPOG

September 2016

• Determined Regulatory approach and content for FDA audience

CASSS • Establish closer working relationship• Determine how to plan for BPOG sessions in CASSS Events

Nadine Ritter, CASSS

January 2017

• Agreed to collaborate on topics and events• Session planned at WCBP for January 2017. Need to prioritise topics

CORE Plan a session with ASEAN Silke Vogel Q2 2017 • Discuss follow up from BPOG Singapore

7/6/2017Reg Int Strategy September 2016 50


Emerging Regulatory Themes

▪Making the right connections at the right time with Regulators

▪Opportunities for Training/Education

▪ Industry Adoption/Implementation of Current Best Practice

▪Enhanced Support to Supply and Patient Challenges

▪Further development of Standards and Harmonisation

▪Global Approach to support robust and reliable supply chains

▪Align on Language and Definitions

517/6/2017

Documents

A Global Technology Roadmap for Biopharmaceutical Manufacturing… · 2018-11-11 · A Global Technology Roadmap for Biopharmaceutical Manufacturing: An Update from BPOG Presentation