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Tech Transfer and Scale-Up for Biopharmaceutical Manufacturing

24 June 2024 | 1 Week Live Online Course

Original price was: £1,395.00.Current price is: £995.00.

(1 customer review)

The price is for all four sessions | Register for Module 1 | Free

Master and implement different biopharmaceutical tech transfer & scale-up techniques

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Register For Module 1 | Free-To-Attend

 

Module 1 of this course is free to attend and delivered online. Register to receive joining instructions for the live event, recording and presentation slides.

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Enrol Before | 23 May To Save £400 | 7 June To Save £200

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Course Overview

 

As biopharmaceutical development progresses, larger quantities of the product are needed for clinical trials and patients. To achieve this, the organisation must scale up using new technologies, facilities, and equipment, which means a Technology Transfer (TT) is necessary.

 

Performing a proper and effective Tech Transfer is crucial. Failing to transfer your process accurately can result in wasted time and money, along with delayed market release of your drug. This interactive course focuses on practical application through case studies and group exercises to solidify your understanding of Tech Transfer planning. Additionally, you can bring any specific challenges you’ve faced to the course and receive expert advice on how to overcome them.

 

With the Educo Post Learning Implementation Plan (PLIP) you will have the framework to apply and implement the knowledge acquired in the training, supporting you in your development. Learn more about how we deliver both online and classroom training courses. 

Course Dates

 

Find out when this course is running so you can plan your training.

24 June 2024

1 Week Live Online Training
Register at the top of the page.

 

2025 Dates TBC

1 Week Live Online Training

Get in touch to register for these dates. The largest price saving of £400 will be applied.

Key Learning Objectives

 

  • Learn how to define a successful Tech Transfer operation
  • Learn what is formally required by the regulators for a Tech Transfer to take place
  • Review and master the various phases of a successful Tech Transfer to ensure you complete it efficiently
  • Learn what tools are available to facilitate a Tech Transfer, including process maps, SOPs and the RACI matrix
  • Learn what risks are associated with the Tech Transfer process, and how to effectively manage them
  • Understand the different types of Tech Transfer that can take place for a biopharmaceutical, such as R&D to manufacturing, and how you transfer analytical methods to ensure product realisation

What is Included in a Live Online Course?

 

  • Direct access to an expert trainer
  • Interactive and engaging sessions with exercises and discussions
  • Bitesize learning
  • Access to the Educo Life Sciences Training Portal
  • Unlimited access to the recordings for 4 to 5 weeks after the last session
  • Reinforcement session delivered 4 to 5 week after the course (online) providing you with extra time with the trainer
  • A validated certificate of attendance available for you to download

Learn more about the course by toggling through the tabs below (trainer, agenda, who should attend?)

Post Learning Implementation Plan (PLIP)

Pre-course

  • Access to the Educo Training Portal
  • Submit your needs analysis and objectives for training by completing a simple online form

Action Plan

  • At the end of the training you will create an action plan to help you implement and develop your new skills and knowledge

Reinforcement Session

  • Delivered 3 to 4 weeks after the training
  • It is a 1 hour virtual session enabling the group to reinforce the key learnings from the training and cover subsequent questions and challenges
Introductory Online Module
FREE to Attend | Live & Recorded

28 May 2024 | 1:00 PM (UK)

Delivered Online

Introduction to tech transfer

  • When, why and how tech transfers are needed
  • Definition of Tech Transfer in this context
  • Different types of tech transfer and why it is common in our industry; challenges of tech transfer
  • Tech transfer as a Project: objectives, stakeholders, deliverables and success criteria project phases, resources, planning tasks and milestones, documentation, risks and reporting
  • Role of CDMOs
  • Contractual requirements
  • Q&A

Register For Module 1 | Free

There are limited spaces on module 1. If demand is high you may not be able to attend the live session, however you will be sent the recording. Priority is given to full registrations.

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Session 1

24 June 2024 | 180 mins | 1:00 PM UK

Introduction to tech transfer

Regulatory, quality and technical aspects of Tech Transfer

  • Regulatory guidelines and requirements/guidance
  • Requirements of different classes of Biologics/Biotech derived products and Biosimilars
  • Hot topics of regulators in this context
  • Audits: facilities, scale, equipment, analytical capability, capacities, timeliness, storage areas fit assessment and expertise and spirit of the team
  • Tech Transfer, risk analyses and change control
  • Regulatory implications and product comparability, which studies need to be performed, when and how to interact with regulators
  • Procedure, Protocol, Report: needs and functions
  • Essential components of procedure/protocols and reports: donor and acceptor sites; roles and responsibilities; resources; documentation received and created; identification of changes; points to consider systematically; dealing with analytics; planning; success/acceptance criteria, risk management
  • Impacts and Mitigation plans in case differences in CQAs are detected
  • Q&A

Group exercise

Together in teams, you will outline a tech transfer protocol and a comparability protocol. You can do this on your own products or as a pretend example.

Session 2

25 June 2024 | 180 mins | 1:00 PM UK

Tools to support Tech Transfer

  • Planning tools and other general project management tools
  • Transfer of process information: scope, identifying different components and differing nature of information. Best suited methods for each.
  • Examples of a tech transfer project plan including typical steps and mile-stones
  • Common formats for product, process, raw material and analytical information (e.g. reports, process description, BFDs etc).
  • Importance of close communication between sending and receiving sites. Soft tools (meetings, woman/man on the plant, shadowing, observation, Q&A, team building)
  • Best practices
  • Q&A

Group exercise

In teams, you will review and select your preferred tools to apply to your example tech transfer.

Session 3

26 June 2024 | 180 mins | 1:00 PM UK

Managing Scale Up of individual process steps as well as process integration in Tech Transfer

  • Technologies and scale-up strategies; examples of cell culture, fermentation, centrifugation, filtration, TFF, Chromatography, formulation and filling operations
  • Introduction to risk analysis, risk management tools and identification of risks
  • Scale up as a significant risk factor: typical approaches and scale up factor. Issues encountered, by process step. Risk mitigation strategies
  • Use of FMEA and process walk downs.
  • Conclusions on risk management.
  • Q&A

Group exercise

In teams you will review a case study and focus on risk management activities during tech transfer.

Session 4

27 June 2024 | 180 mins | 1:00 PM UK

Dealing with Complexity – Open exchange

  • Different types of tech transfer: what makes a tech transfer more or less complex? Nature of product / process; changes; maturity of donor and recipient; stage in life cycle; cultural gap.
  • Experimental components in a tech transfer: lab work, pilot runs, engineering runs.
  • Selection of a receiving site. – main criteria
  • Analytical transfer: specific risks. Different formal approaches. Common problems.
  • Tech transfer strategies during the life cycle.

Conclusions

  • Wrap – up
  • Q&A
  • Feed-back

Dr Margit Holzer has over 25 years of experience in the industry and worked on more than 50 different products. She is a specialist in process, product and analytical method development for biopharmaceuticals. She has extensive expertise in bioprocess in all phases of development including preclinical production, clinical production and large-scale commercial supply.

 

Margit began working at Boehringer Ingelheim, eventually establishing and becoming the head of the new division of manufacturing sciences. She moved on to become the Quality Director and later the Technology, R&D and Innovation Director for NOVASEP in France, before setting her own consultancy. She now assists clients in the evaluation, optimisation and development of processes, analytics and technologies including innovative ones for upstream and downstream processing and formulation.

 

Margit has delivered multiple courses on bioprocess validation. She has helped delegates understand the guidelines and the steps they must take to ensure their operations are compliant. Drawing on her extensive experience Margit provides numerous case studies, examples and exercises during the course.

This course is aimed at professionals who work in biopharmaceutical manufacturing and are involved in technology transfer. These include:

  • Project Managers
  • Bioprocess Scientists
  • Upstream & Downstream Professionals
  • Bioprocess Development
  • Personnel | Bioprocess Engineers
  • Production Personnel/Technicians
  • Quality Assurance
  • Regulatory Affairs

 

It is also relevant for professionals working in cell and gene therapy manufacturing. Margit has experience of working with CGT products.

Most of our classroom courses are located at a venue in central London. The city has good transport links and is good place to socialise with fellow attendees. Accommodation is not included in the price. We recommend staying in a hotel within walking distance of the venue. Lunch and refreshments are included on all days where you will be able to interact with fellow peers and the trainers.

 

The course is held in the following venue:

Hallam Conference Centre, Cavendish Venues, 44 Hallam St, London, W1W 6JJ

 

Link to the Google Map

Learn more about the course by toggling through the tabs below (trainer, agenda, who should attend?)

Free Online Module and Pricing
  • Module 1 is free to attend and is delivered online and is recorded.
  • To enrol onto module 1, please submit your details in the form.
  • Module 1 is recorded so if you are unable to attend, you can catch up ahead of the course start date.
  • There are price tiers for this course. The dates of these are at the located above the course overview.

 

Frequently asked questions (FAQs)

Could your team benefit from this course?

 

We can customise this course to meet the requirements of your organisation, delivered as a classroom and/or online course.

For more information you can email us at [email protected] or call +44 (0) 203 111 7357.

 

Complete our contact form by following the link. Get in touch.

*

• The training course is delivered either online or in a classroom. Please check which course format you have booked.
• In the event we do not have enough people on one of the options we will contact you to discuss switching. If for example we ask you to switch from classroom (in-person) to live online, we will refund you the difference in price.

1 review for

Tech Transfer and Scale-Up for Biopharmaceutical Manufacturing

24 June 2024 | 1 Week Live Online Course

  1. Educo Life Sciences

    This is a new course – Reviews will be added after the first delivery!

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