Trending Technologies in Sterile Product Manufacturing Facilities

Trending Technologies in Sterile Product

Manufacturing Facilities

April 26, 2016

V1.0

Speakers • Principal Process Engineer • DME

Hite Baker Speaker/Moderator

• Project Design Manager • Merck & Co., Inc.

Parag Pande, M.S. ChemE Discussion Panel

• Principal Process Engineer, Vaccine Technology & Eng • Takeda Vaccines

John F. Barnes, P.E. MechE Discussion Panel

• Chief Operating Officer • Cook Pharmica

Ryan Hawkins Discussion Panel

• Director of Manufacturing Operations • Grand River Aseptic Manufacturing

Steve Nole Discussion Panel

• An INTERPHEX 2016 Technical Education Program. • Surveys

– Invited engineers, manufacturers, and other life sciences professionals like you to express views on the latest trends and technologies affecting our industry.

– Two Surveys, executed Q4 2015. • Biopharma Facility Modernization • Aseptic Manufacturing Tech Trends

• Whitepapers, issued April 2016. • Presentations with Distinguished Industry Panels.

• Industry Speaks: Transforming cGMP Manufacturing Facilities • Trending Technologies in Sterile Product Manufacturing Facilities

About DME Facility Focus

Survey Overview

Survey Participants (p5) AFFILIATION JOB FUNCTION

Triggers & Drivers: When Sterile Manufacturing Facility Modernization Becomes a Necessity

6

Why Change?

Sterile Manufacturing Modernization

Obsolescence

Reliability

Sustainability

Safety

Throughput

Flexibility

ROI/COGS

Quality

Regulatory Compliance

Project Drivers

Manufacturing Modernization

Risk Drivers • Product Quality • Regulatory Compliance • Obsolescence • Safety • Reliability

Opportunity Drivers • New Products • Throughput • Flexibility • Sustainability • ROI/COGS

Modernization (p7)

27%+17%+17%=61% What does this mean? Why so high? Should this change? Why/how?

Modernization – Manufacturers vs. Suppliers

Why such a large gap between manufacturers and suppliers?

Timing (p10)

Enablers: Technologies and Trends that

Provide the Best Modernization Solutions

Advanced Aseptic Technologies (p11)

Process Analytical Technology, unsure, etc.

Design Priorities (p21)

Capabilities (p26)

Technologies (p27)

Advancements (p29)

1

2

3

4

5 Ranked 1-5

1 = most frequent

Background Classification (p31)

Decontamination Agents (p34)

Long Term Strategy (p37)

Product Segregation (p39)

Summary

Transforming Facilities

Advanced Aseptic Processing Single-Use/ Disposable Technology

Barrier Systems Quality by Design

Isolators PAT (Process Analytic Technology)

RABS (Restricted Access Barriers) Risk Based Design

BFS (Blow-Fill-Seal) Ready-to-Use Primary Containers

Form-Fill-Seal Flexible Combi Filling Lines, vials, syringes, etc

Automation & Robots Real-time & Rapid Micro Monitoring

Closed Vial Processing Life Cycle Validation

Has there ever been a better time for our industry to focus on engineering issues and how to provide cost-effective sterile-manufacturing facilities that make the best use of available modern technologies to ensure that products of the highest quality are consistently manufactured?

For More Information

• Acquire DME Facility Focus survey whitepapers! – Available at INTERPHEX: DME booth #1666 – Available at www.dmeforlife.com/about-us/facility-focus

after INTERPHEX. • Contact Information

– Hite Baker – hbaker@DMEforLife.com