Biopharmaceutical Course Offerings Expand Your Perspective

Biopharmaceutical Course Offerings Expand Your Perspective. WELCOME Today’s biopharmaceutical manufacturing is governed by increased process and eq...
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Biopharmaceutical Course Offerings Expand Your Perspective.

WELCOME

Today’s biopharmaceutical manufacturing is governed by increased process and equipment complexity, fast changing technology, greater importance of regulatory compliance and frequent production transfers. This means staying abreast of the latest industry advancements is vital for the development and success of a company and its employees.

Our state-of-the-art facility, “Biomanufacturing Sciences & Training Center“, at Singapore is located in Science Park II, has been designed to provide technical support and training services to biopharmaceutical manufacturers who have operations in Asia. The facility spans over 8,000 square feet, is equipped with a pilot plant and process development laboratory to cater to real-life, hands-on training on process operations.

Our courses are designed to help biopharmaceutical manufacturers meet critical needs for process efficiency and current Good Manufacturing Practice compliance. Recognized as best in class, our courses will provide you with broad skills you can develop, rather than just the ability to operate one product.

Whether you are an operator requiring introductory skills or a highly-specialized engineer or scientist looking to enhance your knowledge, you will find an appropriate course in this brochure. We have world class training facilities in North America, France, Singapore, India and in our newest location in Brazil.

We look forward to seeing you at our upcoming programs.

Dr. Bala Raghunath Director - Asia, Biomanufacturing Sciences Network Merck Millipore

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CONTENTS

INTRODUCTION Why train with Merck Millipore?.................................................................................................................................................................................... 6 Merck Millipore facility location .................................................................................................................................................................................... 7 Course application information...................................................................................................................................................................................... 8

BIOPHARMACEUTICAL COURSES NORMAL FLOW FILTRATION Operate Normal Flow Filtration Process Equipment .......................................................................................................................................... 10 Optimize Normal Flow Filtration Processes ............................................................................................................................................................ 11

ASEPTIC PROCESSING Perform Automatic Filter Integrity Testing .............................................................................................................................................................. 12 TANGENTIAL FLOW FILTRATION Operate Tangential Flow Filtration Process Equipment ..................................................................................................................................... 13 Optimize Tangential Flow Filtration Processes ...................................................................................................................................................... 14



CHROMATOGRAPHY Operate Chromatography Process Equipment ...................................................................................................................................................... 15 Optimize Chromatography Purification Processes .............................................................................................................................................. 16



SINGLE-USE TECHNOLOGY Operate Single-Use Technologies ............................................................................................................................................................................... 17



STERILITY TESTING Perform Sterility testing ................................................................................................................................................................................................. 18

TRAINING CALENDAR 2011 calendar ...................................................................................................................................................................................................................... 19

Introduction

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INTRODUCTION

Why train with Merck Millipore? For over 50 years Merck Millipore has worked alongside most of the world’s leading biotechnology companies and pharmaceutical laboratories. Unparalleled application expertise and process understanding enables Merck Millipore to offer you training from upstream and downstream processing to final processing and release. By using senior engineers and scientists to deliver our courses, we ensure that you have the most skilled and knowledgeable trainers in the industry. With offices in 64 countries, Merck Millipore has trained over 10,000 people since it developed certified customer training courses in 1990. As a dynamic, innovative and growing global business, our courses are continually updated to reflect our customers’ success criteria, feedback from course participants and changes in technology. Our courses are balanced evenly between hands-on experience, workshop and theory. All our courses can be adapted to meet your needs. If you need training to be carried out in a local language or to focus on a particular process, please let us know.

Who should participate? Whether you are an operator requiring a certified introduction to a process technology or you want to take your specialized skills to another level, you will find a course that is appropriate for you. Whatever your experience, you will finish a Merck Millipore course with skills you can use now and in the future.

What are the key benefits of attending these courses? • Minimized risk and reduced deviations in your processes. • Increased process efficiency. • Reduced downtime. • Improved troubleshooting ability. • Increased confidence at work. • Improved operator safety.

Certification of courses Merck Millipore is an approved as an Approved Training Organisation (ATO) by Singapore Workforce Development Agency (WDA) since February 2009. At the end of a certifying course, participants will receive a Singapore Workforce Skills Qualifications (WSQ) and Merck Millipore certificate to show the course was successfully completed.

Putting theory into practice It is vital to understand why a technology works as well as how it works. We carefully balance the theoretical and practical elements of our courses. In addition, Merck Millipore’s training courses offer participants a wide variety of hands-on options that make it easier to see theory applied in practice.

About our instructors Merck Millipore’s skilled and qualified instructors are rich with technical knowledge, field experience and teaching capabilities. The balance between theory and practice extends to our instructors who do not spend all their time in the theoretical atmosphere of the classroom; they are also working scientists and engineers who deal with real applications on a daily basis, confronting the same problems as you.

Tailored to your specific requirements Every company has different requirements; that’s why we are extremely flexible and almost everything can be adapted to suit your needs. Most of our courses and training materials are modular, enabling Merck Millipore’s instructors to offer a customized service. They can recommend which modules should be emphasized within the balance of a course. Training can also be adapted to reflect the existing skills of attendees. Courses are divided into different levels so that participants can take the course most appropriate for their skill level. Please contact us to discuss your specific training requirements.

INTRODUCTION

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Location

Key training regulations

Training courses are held at our Merck Millipore facilities.

The U.S. Code of Federal Regulations 21 CFR § 211.25: “Each person engaged in the manufacture, processing, packaging, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions.“

Singapore Merck Millipore Millipore Singapore Pte Ltd Biomanufacturing Sciences & Training Center No. 1 Science Park Road, The Capricorn, #02-10/11, Singapore Science Park II, Singapore 117528 Tel: (65) 6403 5300 Fax: (65) 6403 5322 email: [email protected] Courses at Merck Millipore’s facilities provide:

The EU Guide to Good Manufacturing Practice for Medicinal Products § 2.9: “Besides the basic training on the theory and practice of GMP, newly recruited personnel should receive training appropriate to the duties assigned to them. Continuing training should also be given, and its practical effectiveness should be periodically assessed [...]. Training records should be kept.”

• Easy access to large state-of-the-art equipment. • Opportunities to share experiences with people from a variety of organizations. • Standard training equipment. • Undisturbed time for training away from workplace interruptions.

World class training centers

Billerica, MA USA

Molsheim France

Bangalore India

São Paulo Brazil

Singapore

Merck Millipore has training facilities in North America, France, Singapore, India and our newest center in Brazil.

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INTRODUCTION

Course Application Information Registration Form

Application

To request for a copy of the course registration form, simply email: [email protected] or call (65)6403 5300

• Applicants are required to submit a photocopy of certified supporting documents, identification document (i.e. Academic certificates, NRIC, Passport and a recent photograph) with the original completed application form.

Who should apply? (1) Operators, Technicians, Engineers or Scientists who are currently employed in the biopharmaceutical manufacturing industry and are interested in upgrading and enhancing their skills and capabilities. (2) Professionals from other industries who are interested in pursuing a career in the biopharmaceutical industry.* (3) New graduates in relevant fields who are interested in pursuing career in the biopharmaceutical industry.*

• For applicants who are eligible to the available funding support, their particulars will be submitted to the relevant agencies. • All information submitted is strictly for Merck Millipore internal use only and will be kept private and confidential. Any disclosure will be subject to applicant’s approval.

Matriculation

*Terms and Conditions Apply. Not eligible for WDA funding under STEP Program.

• Millipore trainers will shortlist successful applicants for the course based on documents submitted and/or phone interview.

Entrance requirement

• Shortlisted applicants will be notified by email or phone

Applicants must meet one of the following pre-requisites: (1) NITEC / Higher NITEC (2) Polytechnic Diploma (3) Bachelor Degree or higher (4) Relevant working experience in the biopharmaceutical industry

Course Fee Please refer to individual training modules or check with Merck Millipore personnel.

Certificate Paricipants who meet all competency criteria will be awarded certificates. All certificates must be collected personally from Merck Millipore.

Course eligibility for WDA funding Singaporeans and Singapore Permanent Residents who are: • Employed in the biopharmaceutical industry or related industry. • Maintain a minimum attendance of 75% and meet the competent criteria upon taking the assessment. • Participate in the immediate evaluation for attendee and and a post evaluation for both the participant and their respective supervisor. The post evaluation will take place 3 months after the course ended.

NB: Merck Millipore reserves the rights to make any changes in the entrance requirement, course fee and course schedule at any time.

Biopharmaceutical Courses

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NORMAL FLOW FILTRATION

Operate Normal Flow Filtration Process Equipment T WO-DAY COURSE

What will you be able to do after attending this course? You will understand the best practices techniques for filter installation, the importance of appropriate flushing procedures, and robust methods to carry out filter integrity tests. • Implement best practice procedures for filter installation and flushing

Overview

• Optimize your flushing or wetting procedures

Using a combination of theory and hands-on instruction, participants will learn the fundamental key procedures and ‘best practices’ methods involved in the operation of normal flow filtration process, including filter installation, flushing, steam-in-place and integrity test procedures.

• Establish robust SOPs to integrity test filters

This two day course covers all operation aspects of sterile filter and pre-filter applications for liquid filtration. Participants will be assessed to gauge their understanding of the different topics taught during the training.

• A full set of course notes

WHICH OF YOUR CHALLENGES DOES THIS COURSE ADDRESS?

• Make appropriate decisions when there is a failed filter integrity test • Institute appropriate SIP protocols for your filter assembly

What will you receive? • Certificate of Achievement

Who should attend? The course is designed for operators, technicians or manufacturing associates with a basic understanding of filtration practices

• How filters work • Why are certain filters used for different applications

HANDS-ON PRACTICAL SECTION

• Non-robust filter installation or flushing techniques leading to invalid filter integrity values.

The practical element of this course covers how to:

• Failed or inconsistent integrity test values

• Carry out filter flushing procedures

• Perform filter installation • Perform integrity test procedures • Carry out SIP of a filter assembly

Price SGD 2000 per participant including all course materials (subjected to prevailing government taxes) All fees stated are before any subsidization.

NORMAL FLOW FILTRATION

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Optimize Normal Flow Filtration Processes T WO-DAY COURSE

What will you be able to do after attending this course? You will understand the best practices techniques for filter sizing and optimization, the importance of operating parameters and designing to manufacturing constraints, and validating sizing estimates through appropriate process simulation:

Overview Using a combination of theory and hands-on instruction, participants will learn the key principles and techniques involved in the development and optimization of normal flow filtration processes. This two day course covers all aspects of sizing and scale up of normal flow filters which include the “Vmax™ Technique” for sizing sterile filters, prefilter, virus filters, and the “Pmax™ - Tmax™ Techniques” for sizing depth filters. Participants will be assessed to gauge their understanding of the different topics taught during the training.

WHICH OF YOUR CHALLENGES DOES THIS COURSE ADDRESS? • Undersized or oversized filter configurations in manufacturing. • Manufacturing constraints and their impact on filter sizing. • Scale-up issues encountered during filtration

• Carry out filter sizing evaluations and estimate filter area requirements for normal flow filters • Apply and perform the Vmax™ , Pmax™ and Tmax™ data analysis • Establish optimized filter configuration for an application • Apply appropriate scale-up guidelines to account for manufacturing constraints

What will you receive? • A full set of course notes • Certificate of Achievement

Who should attend? The course is designed primarily for engineers or scientists from R&D, process development, pilot or production facilities. NB: Participants must complete “Operate Normal Flow Filtration Process Equipment” course or have equivalent experience

HANDS-ON PRACTICAL SECTION

Price

The practical element of this course covers how to:

SGD 2000 per participant including all course materials

• Perform Vmax™ , Pmax™ and Tmax™ filter testing evaluation

(subjected to prevailing government taxes)

• Carry out data analysis and estimate filter sizing

All fees stated are before any subsidization.

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ASEPTIC PROCESSING

Perform Automatic Filter Integrity Testing T WO-DAY COURSE

What will you be able to do after attending this course? You will understand the fundamentals of bubble point, diffusive flow and water intrusion tests and the principles of automatic filter integrity test instruments: • Interpret the content of an automatic filter integrity test print-out

Overview

• Decide when and how to test filters in-line

Using a combination of theory and hands-on instruction, participants will learn the key procedures of filter integrity testing, how to interpret print-outs from automatic filter integrity testers and troubleshoot filter integrity test processes.

• Make appropriate decision when a filter integrity test fails

This two day course covers all current filter integrity tests, and bubble point, diffusive flow and water intrusion testing for all liquid and vent filtration applications.

WHICH OF YOUR CHALLENGES DOES THIS COURSE ADDRESS? • Understanding the filter integrity test principles. • Signing an automatic filter integrity test print-out without understanding the content. • Releasing or rejecting a sterile batch with a wrong filter integrity test result. • Uncertainty on how to retest a filter. • Lost production time due to retesting of filters

Price SGD 2500 per participant including all course materials (subjected to prevailing government taxes) All fees stated are before any subsidization.

• Optimize your wetting procedure

What will you receive? • A full set of course notes • Certificate of Achievement

Who should attend? This course is designed for operators or technicians who are responsible for automatic filter integrity testing of sterilizing filters in the biopharmaceutical industry NB: Participants must complete “Operate Normal Flow Filtration Process Equipment“ course or have equivalent experience.

HANDS-ON PRACTICAL SECTION The practical element of this course covers how to: • Perform manual and automatic bubble point testing • Perform manual and automatic diffusive flow testing • Perform manual and automatic water intrusion testing • Troubleshoot integrity testing processes

TANGENTIAL FLOW FILTRATION

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Operate Tangential Flow Filtration Process Equipment T WO-DAY COURSE

What will you be able to do after attending this course?

Overview Using a combination of theory and hands-on instruction, participants will learn the “best practices” procedures to setup and operate tangential flow filtration (TFF) equipment leading to an improved process consistency, reliability and robustness. This two day course covers the central elements of TFF including filter installation, basic operations covering sanitization, water permeability measurement, integrity testing as well as post-TFF procedures such as cleaning, cleaning assessments and storage .

You will understand the fundamentals of TFF process operation and will be able to run an entire TFF process incuding module maintenance: • Assess the integrity of TFF modules • Measure normalized water permeability (NWP) to assess module cleaning effectiveness • Develop your own cleaning procedure • Establish TFF modules replacement criteria

What will you receive? • A full set of course notes • Certificate of Achievement



Who should attend? The course is designed primarily for like operators , technicians or manufacturing associates who are responsible for running TFF processes in the biopharmaceutical industry

HANDS-ON PRACTICAL SECTION WHICH OF YOUR CHALLENGES DOES THIS COURSE ADDRESS? • Ensuring reproducible performance of TFF modules • Avoiding yield losses • Maintaining module longevity • Efficient cleaning and sanitization of TFF modules

Price SGD 2000 per participant including all course materials (subjected to prevailing government taxes) All fees stated are before any subsidization.

The practical element of this course covers how to: • Filter installation and disassembly • Perform integrity test of TFF modules • Measure NWP • Perform standard TFF operations including cleaning and sanitization procedures • Troubleshoot-using real case studies

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TANGENTIAL FLOW FILTRATION

Optimize Tangential Flow Filtration Processes T WO-DAY COURSE

Interactive case study In the second part of this two day course, participants will use data from a real life case study to develop a process from scratch to the final purified product, including membrane and module selection, operating parameters selection, procedure determination, mass balance and yield assessments, system design and introduction to process economics

Overview The first part of this two day course examines theory of tangential flow filtration (TFF) as well as the latest techniques to develop a TFF process. During a practical laboratory session, participants will determine optimum operating conditions using a model feed stream on a laboratory system to perform a concentration and diafiltration. Through a real-life case study, participants will design a TFF process at scale with specific product purity objectives.

What will you be able to do attending this course? You will be able to develop a TFF process with your specific success criteria: • Write and execute a screening and optimization .. protocol • Analyse data to design a robust process • Perform state-of-the-art process scale-up

What will you receive? • A full set of course notes



• Certificate of Achievement

Who should attend? WHICH OF YOUR CHALLENGES DOES THIS COURSE ADDRESS? • Rapid development of a high



performance TFF process • Understanding process scale-up options • Process issues

The course is designed primarily for engineers or scientists from R&D or process development who are responsible for developing and implementing production scale TFF processes NB: Participants must complete “Operate Tangential Flow Filtration Process Equipment” course or have equivalent experience.

• Meeting your product purity and quality targets

Price SGD 2000 per participant including all course materials (subjected to prevailing government taxes) All fees stated are before any subsidization.

HANDS-ON PRACTICAL SECTION The practical element of this course covers how to: • Perform membrane installation • Flushing • Feed flow determination • Determine optimum trans-membrane pressure (TMP) • Conduct concentration, diafiltration and . recovery processes

C H R O M A T O G R A P H Y

Operate Chromatography Process Equipment T WO-DAY COURSE

What will you be able to do after attending this course? You will understand the fundamentals of chromatography required to properly operate chromatography equipment: • Pack and unpack columns at pilot and processscale • Troubleshoot a chromatography step

Overview

• Develop a robust chromatography

Using a combination of theory and hands-on instruction, participants will learn how to pack and unpack columns at pilot/process scale.

setup and operation

This two day course provides a review of the terminology used in process chromatography and its major concepts. It will cover both manual and automatic operations and also includes operational qualification of a chromatography process step.

• A full set of course notes

WHICH OF YOUR CHALLENGES DOES THIS COURSE ADDRESS? • Understanding of chromatography and process design principles

What will you receive? • Certificate of Achievement

Who should attend? The course is designed primarily for operators, technicians or manufacturing associates who are responsible for operating process scale chromatography

HANDS-ON PRACTICAL SECTION

• Insufficient product purity and low process yield due to incorrect or inconsistent column packing

Price SGD 2000 per participant including all course materials (subjected to prevailing government taxes) All fees stated are before any subsidization.

The practical sessions use a range of chromatography columns and media commonly found in today’s biopharmaceutical processes and covers how to: • Manually pack and unpack pilot and processscale columns. • Automatically pack and unpack a processscale column. • Qualify a packed chromatography column • Operate a chromatography step at process scale

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CHROMATOGRAPHY

Optimize Chromatography Purification Processes T WO-DAY COURSE

What will you be able to do after attending this course? You will be able to develop a chromatography process with your specific success criteria: • Write and execute a screening and optimization protocol • Analyse data to design a robust process • Perform state-of-the-art process scale-up

Overview The first part of this two day course examines in depth the theory of chromatography as well as the latest techniques to develop a purification process.

What will you receive?

During a practical laboratory session, participants will use a laboratory system to determine optimum operating conditions for a purification and separation process of a model feed stream. Through a real-life case study, participants will design a chromatography process with specific product purity objectives.

Who should attend?

WHICH OF YOUR CHALLENGES DOES THIS COURSE ADDRESS? • Rapid development of a high performance chromatography process

• A full set of course notes • Certificate of Achievement

The course is designed primarily for engineers or scientists from R&D or process development who are responsible for developing and implementing production scale chromatography processes NB: Participants must complete “Operate Chromatography Process Equipment” course or have equivalent experience

HANDS-ON PRACTICAL SECTION

• Understand process scale-up options

• Meeting your product purity and quality

The practical sessions use a range of chromatography columns and media commonly found in today’s biopharmaceutical processes and covers :

targets

• Laboratory scale column packing

• Process issues • Understand process scale-up options

• Flushing and equilibration

Price SGD 2500 per participant including all course materials (subjected to prevailing government taxes) All fees stated are before any subsidization.

• Determination of optimum process conditions (loading, elution, cleaning) for affinity and ion-exchange chromatography

SINGLE-USE TECHNOLOGY

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Operate Single-Use Technologies T WO-DAY COURSE

What will you be able to do after attending this course? You will understand the best practice techniques for disposable components integration installation, the importance of appropriate flushing, operation and product recovery procedures including how to: • Implement best practices procedure for disposable installation and handling

Overview Using a combination of theory and hands-on instruction, participants will learn the key procedures and “best practices” methods involved in the operation of disposable single use components, including filters, connectors, bags, mixers and tubings. Installation, flushing, sanitization and integrity test procedure are also taught and discussed. This two day course covers all operation aspects of disposables in Biomanufacturing. Participants will be assessed to gauge their understanding of the different topics taught during the training.

WHICH OF YOUR CHALLENGES DOES THIS COURSE ADDRESS? • Inappropriate integration of disposable components leading to operational complication • Damage to bags • Failed sterility due to improper sampling or connection practice

• Optimize your flushing or wetting procedures • Establish robust product recovery • Make appropriate decisions when there is a sterility or integrity failure • Institute appropriate rinsing protocols for your disposable assembly

What will you receive? • A full set of course notes • Certificate of Achievement

Who should attend? This course is designed for operators , technicians or manufacturing associates with a basic understanding of disposables technology in biomanufacturing or previous experience in pharmaceutical processing using traditional stainlesss steel component.

HANDS-ON PRACTICAL SECTION The practical element of this course covers how to:

Price

• Install disposable components and assemblies

SGD 2500 per participant including all course materials

• Carry out aseptic connections

(subjected to prevailing government taxes) All fees stated are before any subsidization.

• Perform integrity test procedures on capsules • Carry out mixing and fluid transfer

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STERILITY TESTING

Perform Sterility Testing T WO-DAY COURSE In a hands-on interactive workshop, participants will learn how to perform a sterility test. Participants’ case studies will also be discussed. The workshop will aid the understanding of the lecture contents with practical applications. All critical handling steps in the sterility testing procedure and its consequences on test results are discussed and solutions are explained and demonstrated. Our experienced trainers will also provide valuable suggestions to help ensure regulatory compliance.

Overview “Because Sterility Testing is a very exacting procedure, whereas asepsis of the procedure must be ensured for a correct interpretation of results, it is important that personnel be properly trained and qualified”- United States Pharmacopeia General Chapters This two day course provides an in-depth review of the regulatory requirements of sterility testing, its validation and practical implementation. The course is based on the most recent editions of pharmacopeias and provide information about the harmonization and differences between the United States Pharmacopeia (USP) and the European Pharmacopeia (EP).

What will you be able to do after attending this course? You will get a better understanding of the current requirements of pharmacopeias and be familiar with good sterility testing procedures from method development/ validation through to routine test result interpretation: • Take preventive actions to avoid false positive or false negative test results • Develop and optimize sterility testing procedures • Understand and identify root causes for common handling issues

What will you receive? • A full set of course notes

WHICH OF YOUR CHALLENGES DOES THIS COURSE ADDRESS? • Handling issues • False positive test results • Validating products with inhibitory activities - false negative test results

• Certificate of Achievement

Who should attend? The course is designed primarily for quality control, quality assurance or regulatory affairs personnel who perform or responsible for the performance of sterility test

• Optimizing sterility testing procedures

HANDS-ON PRACTICAL SECTION Price SGD 2000 per participant including all course materials

The practical element of this course covers how to:

(subjected to prevailing government taxes)

• Use of Steritest™ hardware

All fees stated are before any subsidization.

• Use of Steritest™ units • Demonstrate general and specific sterility testing applications • Troubleshoot specific user-related situations

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Please contact your local Merck Millipore representative or e-mail [email protected] for any training related enquiries, updated training calendar or quotation.

** Minimum required 6 participants or more to commence a class.

Merck Millipore Millipore Singapore Pte Ltd Biomanufacturing Sciences & Training Center No. 1 Science Park Road, The Capricorn, #02-10/11, Singapore Science Park II, Singapore 117528

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Tel: (65) 6403 5300 Fax: (65) 6403 5322 email: [email protected]

www.merckmillipore.com Lit. No. DMBSTC-SGTRAINING2011EN00 Rev A 04/2011 The M logo is a trademark of Merck KGaA, Darmstadt, Germany. © 2011 Merck Millipore. All rights reserved. Printed in Singapore .