Bio assays are experiments conducted in vivo and in vitro to determine the response of a drug. They are used in development during drug discovery to find potential drugs and they are also used in manufacturing as a means of quality control.
This course will cover basic computational processes necessary for analysis of the data from immunoassays and bioassays. Important considerations will be examined such as determining optimal assay conditions, choosing the appropriate nonlinear or linear regression fit, calculating correct residual weights, computing practical limits of sensitivity and acceptable error, measuring non-parallelism and potency, and compensating for matrix effects. These and other computational decisions will be discussed and examples will be presented showing different considerations.
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
Who Should Attend
This course is designed for all individuals who develop, validate, perform or monitor bioassays or immunoassays. Individuals who develop assay methodologies, assign computational and analysis criteria, measure and validate performance characteristics, perform, evaluate and troubleshoot problem assays, or are responsible for the quality of the data will benefit from the lessons and examples presented. Attendees should have a basic understanding of bioassays or immunoassays. Relevant departments may include:
- Quality Control (QC)
- Quality Assurance (QA)
- Cleaning Validation
- Regulatory Affairs
- Process Development
- Product Development
- 5 weeks
- 2 hours per week (average)
Click here: https://vle.knect365.com
Dr. Melody Sauerborn
Dr. Melody Sauerborn spent most of her early scientific career at prestigious institutes such as the Centers for Disease and Control Prevention in the USA. After successfully finishing her Master of Science, Dr. Sauerborn worked for several Public Relations agencies in the healthcare divisions as project manager. Additionally, she was involved from early age as the CEO of a German spin-off. Succeeding her scientific dissertation in the field of protein drugs and adverse immune responses, she founded ADA InVivo, a biotech CRO in the field of drug safety. Besides that, she also works as a consultant, is involved in another biotech start-up and functions as a speaker/ trainer at international conferences and workshops.
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.
Module 1: Basics of biological assays
- Definitions and clarifications on terminologies
- Potency, immunogenicity, concentration assays
- Immunoassays (ligand-binding assays)
- Bioassays (cell-based assays)
Module 2: How to develop an assay – immunoassays
- Critical factors in assay development
- Critical reagents
- Hook effect
Module 3: How to develop an assay – immunoassays, continued
- OFAT versus DOE
- Assay trouble shooting, e.g. matrix effects
Module 4: How to develop an assay – bioassays
- Critical factors in bioassay development
- Cells, cells and more cells
- Cell banking for non-producing cells
Module 5: Biostatistics
- Curve fitting – PLA/ 4 and 5 PL
- Correlation coefficient – R2
- Applying a weighting function to a sigmoid curve
- Relative potency assessment
- Parallelism vs
Module 6: Validation of an immunoassay
- History & overview guidelines The GxP system
- Validation in detail, incl. pre-study and in-study
- standard curve
- quality controls
- incurred sample reanalysis
Module 7: Validation of a bioassay
- Bioassays versus immunoassays
- Specific considerations for bioassays
- Guidelines overview
Module 8: Assays in immunogenicity
- Short intro into immunogenicity
- Extra considerations: assay cut point
Module 9: Validation versus qualification
- Partial/Cross validation
- Tiered approach vs fit for purpose
Module 10: Assay monitoring & troubleshooting
- Monitoring assay performance over time
- Identifying and managing sources of assay variability
- Analysing and optimising assay performance
On-site & in-house training
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