Bio Campaign production

1. Campaign Production Aspects
By
V.Nataraja Sekhar Reddy
V.C.E.R
M.Tech Biotechnology

2. Introduction
 What is a Biopharmaceutical?
 Biopharmaceutical, also known as a biologic medical product or
more simply as a biologic, is any medicinal product manufactured in
or extracted from biological sources.
 Most often used to describe products that are produced by
recombinant DNA technology
 Monoclonal antibodies (mAbs) ,Hormones ,First approved
commercial product was Humulin® (Genentech/Eli Lilly), 1982

3. Introduction
 Bio Similar
 A drug similar to a biologic drug that has already been approved (the
“originator”).
 The active ingredient of a bio similar is like that contained in the originator
biologic.’
 Biologics made by different manufacturers differ from the original product
and from each other.

4. What Makes a Successful Biological Product

5. Bio Market
 $442 bn Combined Revenue of Top 10 Global Bio pharm Companies

6. Strategy Through Execution Approach

7. Purpose
 These production lines must be set up or cleaned between the processing of
different production charges or before downtimes.
 The products manufactured must often not only be stored finally but also
temporarily, for example, if they are to be consumed by a subsequent
manufacturing level.
 These setup or clean-out processes as well as the storage may be very cost-
intensive.
 The main aim of campaign planning is to weigh up setup costs and storage
costs.

8. Process Overview(Biologics)
Virus inactivation
Virus removal
Harvest
FiltrationFiltration
Chromatography column (Size
Exclusion) Chromatography column (Ion
Exchange)
Chromatography column
(HIC)
WCB
Bioreactor (fermentation)
Filtration
Sterile fill
lyophylization

9. Campaign Framework
 Campaign I
 Based on demand forecasts
 Product groups are placed on each machine at each time
 Updated at least every 3 months. Horizon: 1 year
 Campaign II
 Plan is adjusted to the orders that have been received
 Updated every week. Horizon: 3 months
 Campaign III
 Detailed schedule of prodcution tasks
 Based on confirmed customer orders
 Updated every day. Horizon: 1 month

10. Campaign Planning
Optimize campaign plan
Fulfill predicted demand
Minimize production time
Helpful for purchasing raw
material
The model is updated
every 3 months

11. Campaign Planning
 Actual orders are known
 Revise campaign plan
 Allocate orders to campaigns
 Specify in which campaign each
order are produced on every
production stage
 It gives the latest allowed
completion time for the order

12. Campaign Planning
 Actual timing of activities
 Objective to minimize late
deliveries
 The model gives:
 Machine/Campaign for each order
for every production stage
 Production sequence of orders
 Start and processing time of tasks
 Setup time required between
orders

13. Design and Operation of Multi-Product Facilities
1.Applications of Multiproduct Plant Modeling:
Typical applications of multiproduct plant modeling include:
 Capacity Analysis and Strategic Planning
 Production Scheduling
 Facility Design and Debottlenecking
2. Approaches to Modeling of Multiproduct Batch Plants
 Spreadsheet Tools
 Batch Process Simulation Tools
 Discrete Event Simulation Tools
 Mathematical Optimization Tools
 Recipe-Based Scheduling Tools

14. 1.1.Capacity Analysis and Strategic Planning
 The objective of capacity analysis for strategic planning is to determine the best
location to manufacture a set of products over a time horizon of a year or
multiple years.
 The expected demand of a product is translated into a campaign of a certain
number of batches for a specific production line

15. 1.1.Capacity Analysis and Strategic Planning

16.  1.2.Production Scheduling
 Capacity analysis, production planning and scheduling must consider the
availability of plant resources in order to determine the time horizon for
production of various products
 The time horizon for production scheduling is generally much shorter than the
time horizon for capacity analysis and long term planning.
 Recipe Overview and Schedule Generation
 Accounting for Buffer Preparation and Holding
 Considering Labor Constraints
 Production Tracking and Rescheduling
 How much can I produce in a given period of time with the resources that I
possess?

17.  1.3 Facility Design and Debottlenecking :
 Sizing of Utility Systems
 Biopharmaceutical plants utilize purified water of multiple grades, such as
reverse osmosis .
 The sizing of a water system involves a trade-off between the size of the
holding tank and the capacity of the generation unit (e.g., a still in the case
of WFI).
 The minimum still size corresponds to the average overall WFI demand
over an extended time period.
 The smallest still capable of meeting average plant demands results in a
very large and expensive holding tank in order to even out fluctuations in
WFI demand.
 Steam generation systems, the steam accumulator plays the role of the
storage capacity

18.  Estimating Floor Space for Mobile Units:
 The capital investment for mobile units is much lower than the capital
investment associated with fixed tanks.
 Mobile units do not need to be cleaned or sterilized, which reduces labor
requirements, utilities, cleaning materials, and liquid waste treatment. It also
eliminates the need to perform cleaning validation for the units.
 This reduces the number of units needed and/or reduces the likelihood that the
main process will be delayed while waiting for a unit to become available.

19. Mobile equipment floor space requirement

20. Production Process Development Cost

21. Cutting Costs
 The prospect of reduced prices on expensive biotech therapies is the main
force behind the push for follow-on biologics.
 The high cost of developing new biologics—which the Tufts Center puts at
$1.25 billion fully capitalized—and more expensive manufacturing processes
warrant stronger protection from patent litigation, industry claims
 To assist manufacturers, the agency is developing a guidance to clarify what
data it recommends for developing follow-ons of those biologics governed by
the Food, Drug and Cosmetic Act

22. Conclusions
 Process simulation and production scheduling tools can play an important role
throughout the life cycle of process development and product commercial.
 In process development, simulation tools are becoming increasingly useful as
a means to analyze and evaluate process alternative sization.
 When transitioning from development to manufacturing, simulation models
enable efficient technology transfer and process fitting
 In manufacturing, production scheduling tools play a valuable role by
generating feasible production schedules and enabling manufacturing
personnel to efficiently handle process delays and equipment failures.
 The biopharmaceutical industry has only recently begun making substantial
use of advanced process simulation and scheduling tools for process design,
analysis, and improvement

23. Thank You
(V.C.E.R)