Continuous manufacturing has served as a longstanding process in multiple industries and in recent years it has developed within the biotechnology sector. As companies seek to lower the capital and operational cost of the manufacturing process for their biological drug, adopting a continuous or semi-continuous train to process development has increased in popularity.
Although continuous manufacturing presents significant benefits such as increased productivity and reduction of human error, it is still a new concept which comes with a lot of tacit knowledge to be developed and questions to be answered.
Over the course of 5 weeks, the course will address questions and challenges in continuous manufacturing by providing a step-by-step guide on how to adopt a continuous process, complemented by real-life case study examples and an overview of the regulatory landscape.
Key Benefits of Attending
- Understand the basic principles of biological assays
- Learn how to develop bioassays and immunoassays
- Comprehend the necessary biostatistics
- Validate an assay to meet regulatory requirements
- Build measurement systems
- Consider assay layout
- Select mathematical curve models to analyse your data
- Validate and qualify your choice of model
- Equip yourself with a baseline understanding of the key definitions associated with developing a continuous process
- Gain a comprehensive overview of the regulatory and quality background relevant to continuous bioprocessing
- Follow a step-by-step guide on how to develop a continuous process, taking into account process design, integration and cost efficiency
- Fully comprehend the continuous filtration and ultrafiltration processes
- Understand first-hand how to operate a continuous process through a series of case studies
Who Should Attend
Personnel involved in:
- Process Validation
- Process Engineering
- Technical and Operational control
- Quality Assurance
- Regulatory Affairs
- 5 weeks
- 2 hours per week (average)
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- Richard Francis has experience in developing continuous processes for a multitude of companies, ranging from early 2000s to 2018. Richard also has experience in teaching this.
- This course is one of a kind, there aren’t any others available on the market, only conferences including continuous manufacturing as a topic area within them.
- Case studies based off Richard’s experience will help you take all the knowledge learned on the course and understand it from a real-life, practical perspective – so you will benefit from a practical understanding of the continuous process and the flexibility of the online academy all at once.
Why Attend An Online Academy?
Online Academy is an excellent forum to correspond with the teacher/instructor and your fellow students within the course while saving time, cost while maximising the effectiveness of bitesize chunks-learning and regular revisions
- Grow as a team – with multiple licenses your team can access the course and learn together, no matter where they are in the world
- Review all content as many times within enrolment period (two month after all modules have been released)
- Time effective – bitesize chunks so it does not impact on your normal working day
- Progress through the course with fellow students as you would in a classroom
- Discuss the course with fellow students
- Cost effective – no travel expenses
About BioProcess International Academy
BioProcess International Academy is a partnership between BioProcess International (BPI) and Pharmaceutical Training International (PTI). Our vision is to accelerate the growth of the biopharmaceutical sector by providing training solutions which are designed to enhance the technical skills, knowledge and competencies of biotech professionals. The Academy’s extensive course portfolio is determined by the latest industry trends and created by our global network of leading experts and delivered via workshops, digital academies and customised onsite programs.
BioProcess International Academy’s vision is to accelerate the growth of the biopharmaceutical sector by providing training solutions which are designed to enhance the technical skills, knowledge and competencies of biotech professionals. The Academy’s extensive course portfolio is determined by the latest industry trends and created by our global network of leading experts and delivered via workshops, digital academies and customised onsite programs.
Upon completion of your BioProcess International Academy online course you will be awarded with the CPD Certification certificate. This is a recognised independent CPD accreditation compatible with global CPD principles.
The Certificate of Achievement provides proof that you have taken the course and can be used on your CV or work portfolio.
Do sessions go out live?
No, all content is recorded and a set number of modules are released per week. You have unlimited access to module content once it has been released for the duration of the course and an additional two months.
Can I join after the course start date?
Yes, because modules are not live and all content is recorded you can catch up. Please contact us at email@example.com to enquire about joining a course after the start date.
Can I still take part if I’m away for part of the course run?
Yes. Online Academies provide a flexible learning format. As modules are not released live and are available for review, you will be able to catch up.
How long is my enrolment on the course?
You are enrolled on the course for the period that modules are being released and the trainer is active on the discussion forum (this varies from course to course – between 3 – 8 weeks) and for an additional 2 months after this to review course content.
Who do I contact if I have any problems while the course is running?
You should contact BPIfirstname.lastname@example.org
When will I receive my log-on details for the course?
Once you have paid, a member of the team will be in touch with your log-in details. We must receive payment for you to access the course.
How can I access the content?
Content is hosted on our Learning Management System, which you access using your device. A link will be provided to you with your log-in details.
What if I need extra time on the course?
Please contact us at email@example.com if you would like extra time on your course beyond the enrolment period. Extra time is subject to approvals and fees may apply.
Introduction to Continuous Manufacturing
- ICH Guidelines
- Quality Considerations
- Applications of Quality by Design approaches
Regulatory and Quality Background
- Scale vs. Cost
- Process Design and Integration
- Development of Process Control Strategies for Continuous Process
- Process Control:
- Introduction to PAT Systems
- Use of real-time feedback
- Addressing challenges – how to perform a product recall and what is a batch?
- Cleaning validation
How to Develop a Continuous Process
- Perfusion fermentation and cell culture
- Chromatographic processing
- Powder and tableting processes
Case Studies – Continuous Process Operations
- Fill and Finish processes
On-site & in-house training
Deliver this course how you want, where you want, when you want – and save up to 40%! 8+ employees seeking training on the same topic?
Talk to us about an on-site/in-house & customised solution.