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Aseptic Manufacturing of Biopharmaceuticals

2019 PDA Aseptic Manufacturing of Biopharmaceuticals Conference

Oct 01 - Oct 02, 2019
Incheon, South Korea

Annex 1, Fill-Finish Operations, and Final Product Testing

  • Conference
  • Asia-Pacific
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Program Highlights

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Overview

The technological developments and the new regulations have a strong impact on the pharmaceutical manufacturing. In this conference we focus on the aseptic processing, especially fill finish operations of biopharmaceuticals.

Conference Discussions will include:

A Regulatory update: What is new in the draft Annex 1? This has an impact on European manufacturer but also on the member countries of PIC/s. Inspectors from Europe and Korea will share their perspectives and discuss the potential impact on aseptic manufacturing

The environment of aseptic manufacturing: What are most advanced technical solutions from barrier systems, contamination control,  cross contamination avoidance, testing and unit operations

Fill-finish operations: Standard filling lines, robotic systems, qualification, process simulation and regulatory aspects

Pharmaceutical Product quality testing: The technologies on visual inspection and container integrity, the current regulatory trends will be highlighted

The Conference will close with a panel discussion focusing on the future of fill-finish operations.

In addition there will be an exhibition at the conference and several training courses.

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Agenda

  • Day 1
  • Day 2

  • Tuesday, 1 October

    08:00 - 17:00
    Registration Open

    08:00 - 09:00
    Continental Breakfast

    09:00 - 09:10 
    Opening Remarks
    Georg Roessling    , PhD, Senior Consultant, Business Development Asia, PDA
    Woo-Hyun Paik, PhD, Korea Pharm. Tech Education Center (KPTEC), PDA Chapter President, Korea 

    09:10 - 10:30
    P1: Regulatory Update
    This session is dedicated to the upcoming new guideline Manufacture of sterile Medicinal Products, GMP Guide Annex1. The document is still in draft but is to be expected that most parts will be in the final document. This document has been developed by the European Medicines agency (EMA) and by inspectors of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). Since PIC/S has more than 50 member states, including MFDS from Korea, it is very important for anyone dealing with sterile products.

    The session will have presentations from inspectors explaining what is new in the document compared to the old guideline. Additionally, there will be presentations about filtration (including PUPSIT), single-use systems, isolators, clean room behavior like gowning, environmental monitoring, process simulation and validation. All presentations will address the practical aspects and refer to the new guidance document.

    09:10 - 10:15
    Draft Annex 1: What is New? What is Different?
    Rico Schulze, GMDP Inspector, Saxon State Ministry of Social Affairs and Consumer Protection

    10:15 - 10:30
    Question & Answer/Discussion

    10:30 - 11:00
    Coffee Break and Exhibition

    11:00 - 12:00
    P1: Regulatory Update CONTINUED

    11:00 - 11:45
    Potential Impact of Draft Annex 1 on Sterilizing Filtration and Single-use Systems for Sterile Medicinal Product Manufacture
    Michael Payne    , Biosafety Technical Consultant, Merck

    11:45 - 12:00
    Question & Answer/Discussion

    12:00 - 13:00
    Networking Lunch

    13:00 - 15:00
    P2: Environment of Aseptic Manufacturing
    Hygiene and disinfection are an important part to maintain a suitable environment for sterile manufacturing. For aseptic processing barrier systems like isolators or RABS are becoming the standard. Presentations will address contamination control, cross contamination, cleaning and disinfection of clean rooms and isolators.

    13:00 - 13:45
    Contamination Control
    Richard Chai,     Technical Service Manager, STERIS Corporation

    13:45 - 14:30
    Barrier Systems
    Richard Denk,     Senior Consulting Aseptic Processing & Containment, SKAN AG

    14:30 - 15:00
    Question & Answer/Discussion


    15:00 - 15:30
    Coffee Break and Exhibition

    15:30 - 17:45
    P3: Primary Packaging and Devices for Biotech Products
    Primary packaging components and the knowledge of the interaction of the product are most important to ensure product quality of the shelf life period. The presentations in this session show what chemical and physical aspects need to be considered when developing a container closure system, especially for biotech drugs.

    15:30 - 16:15
    Design Considerations In The Development Of A Suitable Plunger For Application In A Pre-filled Syringe System
    Sok Tiang Koh, BSC (Pharm) (Hons) MBA,VP, Scientific Affairs & Technical Services, Asia Pacific, West Pharmaceuticals Services

    16:15 - 17:00
    Primary Packaging and Injection Systems for Biopharmaceuticals: The Role of an Integrated Approach from Design to Final Device Assembly
    Paolo Golfetto, Stevanato Group

    17:00-17:45
    Primary Packaging Solutions for highly Sensitive Biotech drugs
    Bernhard Hladik, Schott

    17:45 - 18:15
    Identifying the Root Cause of Glass Defects and Other Challenges in Your Fill & Finish Manufacturing Line by Using the Quantifeel System
    Jaime Cobo,     Smart Skin Technologies Europe

    18:15-18:30
    Question & Answer/Discussion

    18:30 - 20:00
    Networking Reception



  • Wednesday, 2 October

    08:00 - 17:00
    Registration Open

    08:00 - 09:30
    Continental Breakfast

    09:30 - 13:00
    P4: Fill-Finish Operation: From Fill System to Complete Filing Lines
    This session starts with the selection of fill systems. It will be answered what are criteria and how to verify them by experiments. Besides the fill system a filling line has several more elements like container handling, stopper setting, IPC testing and more. The second presentation will describe a complete filling line and will discuss and compare different ways of handling containers in a filling line.

    09:30 - 10:15
    Selection of Fill Systems for Injectable Drugs
    Tobias Goettler, MSc, Product Manager, Bosch Packaging Technology K.K.

    10:15 - 11:00
    Robotic Systems in Aseptic Production: The Way of Future Aseptic Manufacturing?
    Matthias Poslovski, Dipl.-Ing. (FH), Vice President Sales Turnkey, OPTIMA pharma GmbH

    11:00 - 11:30
    Coffee Break and Exhibition

    11:30 - 12:00
    P4: Fill-Finish Operations: Robotic Handling for Filling of Containers in an Aseptic Environment CONTINUED
    The session shares experiences with robotic filling lines and discusses isolators without gloves. Special features are described and potential advantages are described and potential advantages are highlighted.

    11:30 - 12:15
    Real-World Results Using A Closed Robotic Aspetic Filling Workcell
    Jessica Zhang,     Wuxi Biologics
    John Harmer,     Director of Sales, Vanrx Pharmasystems

    12:15 - 13:00
    Facility of the Future: Pharma Integration™ An Aseptic Smart, Modular, Gloveless Robotic Filling Isolator
    Cristina Testoni, Business Development, Pharma Integration

    13:00 - 14:00
    Networking Lunch

    14:00 - 16:15
    P5: Pharmaceutical Product Quality Testing: Container Integrity
    The Container system of a pharmaceutical product must ensure that during shelf life the product quality meets the quality specification. The integrity of the container is therefore most important.  Though a container closure system is validated there are chances that during a fill finish process deviation might occur which are outside of the validated space. Therefore, for vials, syringes and cartridges integrity test must be performed after manufacturing. This session presents technologies for integrity testing of liquid and freeze-dried products. Finally, a case study is presented which shows the challenges of testing products with different viscosities. The draft Annex 1 requests increased testing on container integrity.

    14:00 - 14:45
    Container Integrity for Liquid Products
    Oliver Stauffer, PTI Packaging Technologies

    14:45 - 15:30
    Container Integrity for Lyo-Products
    Evan Davis, Product Manager, Lighthouse Instruments

    15:30 - 16:15
    CCIT Blue Dye Ingress Test - Influence of Product Viscosity on Detection Rate
    Benedikt Herold MSc, Head of Laboratory; QC of Incoming Goods Vetter Pharma-Fertigung GmgH & Co. KG

    16:15 - 16:35
    User Requirement Specification (URS) for Leak Testing Machines
    Giovanni-Benedetto Golinelli, MPhys, Area Sales Manager, Bonfiglioli Engineering Srl

    16:35 - 17:00
    Coffee Break and Exhibition

    17:00 - 18:30
    P6: Pharmaceutical Product Quality: Visual Inspection
    For parenteral products each container has to be visually inspected. This is a regulatory requirement.  The two  presentations will share automatic inspection in production and the challenges of detection of gas bubbles and particles.

    17:00 - 17:45
    Visual Inspection-Implementation of an Automated Inspection Machine Under Production Conditions
    Jose M. Zanardi-Ocampo, PhD, Senior Manager Engineering Vision Technology, Bosch Packaging Technology K.K.

    17:45 - 18:30
    How to Reliably Distinguish Between Particles and Air Bubbles When Inspecting Parenterals: A New Method Using Spectral-Coded Illumination Minimizes the FRR Significantly
    Christian Scherer, Seidenader

    18:30 - 19:15
    P7: Panel Discussion with Prepared Questions

    • Questions to the regulatory inspectors
    • Garments, Gowning procedures, cross contamination
    • Process simulation/media-fills/process validation: matrix/bracketing approach
    • Product testing, what and how much?

      We invite you to send your questions to PDA : [email protected], so we can answer this at the conference or in the panel discussion
     

    19:15
    Closing Remarks
    Georg Roessling    , PhD, Senior Consultant, Business Development Asia, PDA



Highlighted Speakers

Richard Denk
Richard Denk
SKAN AG
Tobias Goettler
Tobias Goettler
Robert Bosch Packaging Technology GmbH
Giovanni-Benedetto Golinelli
Giovanni-Benedetto Golinelli
Bonfiglioli Engineering Srl
Benedikt Herold
Benedikt Herold
Vetter Pharma-Fertigung GmbH & Co. KG
Sok Tiang Koh
Sok Tiang Koh
West Pharmaceuticals Services
Matthias Poslovski
Matthias Poslovski
OPTIMA pharma GmbH
Rico Schulze
Rico Schulze
Saxon State Ministry of Social Affairs and Consumer Protection
Cristina Testoni
Cristina Testoni
Pharma Integration
View All

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

  • Accreditation

    Accreditation

    Continuing Education for Pharmacists

    ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:


    Type of Activity: Knowledge

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (CPE) credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE-accredited activity. Always submit CPE activity claims as soon as possible. For more information, please visit the ACPE or NABP website.

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Travel

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Sheraton Grand Incheon Hotel

153 Convensia-Road
Incheon, South Korea
Phone: +82 32-835-1000

Make a Reservation
Sheraton Grand Incheon Hotel
  • Accommodations

    A block of rooms have been reserved for meeting participants.  The rate is $170000 KRW/night.

    Reservations must be secured by Saturday, September 14, 2019.  After this date, reservation can be made on a space and rate available basis only.

    Book your room at the discounted group rate here:
    https://www.marriott.com/event-reservations/reservation-link.mi?id=1562922487934&key=GRP&app=resvlink

    Individual Cancellation

    Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. Individuals will be responsible for payment of their own cancellation fees. The cancellation policy is 3 days in advance of arrival unless otherwise specified on your reservation information.

    Letter of Invitation

    If you are requesting an invitation letter please note that you are required to complete the registration process including the final payment before the letter can be provided.  Please email [email protected] to request a letter of invitation. 
  • Amenities

How to Get Here

By Air

Incheon International Airport (ICN)

Hotel direction: 15.5 miles W
Airport shuttle service, reservation required, fee: 95000 KRW (one way) 24 Hours, 7 days a week
Shuttle Phone: +82 32 8351000

Estimated taxi fare: 40,000 KRW (one way)
Bus service, fee: 7,000 KRW (one way)

Gimpo International Airport (GMP)

Hotel direction: 21.7 miles NE
Airport shuttle service, reservation required, fee: 95000 KRW (one way) 24 Hours, 7 days a week
Shuttle Phone: +82 32 8351000

Estimated taxi fare: 40,000 KRW (one way)

By Car

Car Rentals

Lotte Rent-A-Car
145 Chungneung-daero
Incheon, 21930
Phone: +82 032 882 ext. 8001

Hertz
Incheon Inter AP Passenger Terminal
Incheon,
Phone: +82 32-743-8000

Other Options

Subway Station

Incheon University Station 0.5 miles NW from hotel

Directions

Registration Fees

Regular Price
Registration Type  
Conference
Member $599 USD
Non-member $799 USD
Government $399 USD
Student $399 USD
Young Professional Member $399 USD

Letter of Invitation

If you are requesting an invitation letter please note that you are required to complete the registration process including the final payment before the letter can be provided.  Please email [email protected] to request a letter of invitation.






* For this member type or discounted rate, online registration is not available and must be faxed in.

† You must be a member to receive this rate.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Group Registration Discount

Register 3 people from the same organization as a group (at the same time) for the Conference or Workshop and receive the 4th registration free. Other discounts cannot be applied.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact [email protected] or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent 30 days before the event, no fee will be charged. After this period, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent 30 days before the event, a full refund will be given minus a $200 fee. After this period, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.

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