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A practical approach to raw material sourcing and management in cell culture
1. A Practical Approach to
Raw Material Sourcing and
Management
Cell Culture World Congress, Munich Germany
Marlin Frechette
Director, Quality Systems and Regulatory Affairs
Irvine Scientific
3. Irvine Scientific
Introduction
40-year Cell Culture History
•
Markets Served
•
•
•
Global Coverage
Biopharmaceutical
Medical Markets
Cell Therapy
Parent Company – JX Holding (Japan)
•
25 years
4. Raw Material Program
Historical Events
Year
Biological Product or Vaccine
Contaminant
1940s
Yellow Fever Vaccine
Avian Leukosis Virus
Hepatitus B Virus (28,000 cases)
1950s
Polio Vaccine
SV-40 and Polio (Cutter)
1980s
Human Growth Hormone
Creutzfeldt-Jacob
1980s
Blood Derived Products, 1990s
HIV, HBV, HCV, HAV
1990s
Monoclonal Antibodies
LCMV, MVM, EHDV
2000s
Animal Derived Raw Materials
BPyV, Cache Valley
2000s
Recombinant Proteins
Vesivirus, REO-Type 2, MVM
2010
Vaccines
Porcine Circovuirus
(DNA Sequences Only)
Source: “Cell Line Testing, Raw Material Considerations, and Regulatory Guidance”, by Alan Moore, A General Presentation to Irvine Scientific,
May 6, 2011, WuXi AppTec
6. Operational Excellence
Industry Best Practices
1.
Sourcing Strategy
•
Influences Supply
Chain Transparency
Suppliers
Total
Standar
Custom
d
Part #
Part #
Total
Percent
(%)
51
-
24
11
28
55%
Distributors
•
27
Manufacturer
Baseline
46
22
16
23
45%
Direct Manufacturer
52%
40%
-
-
Table 1. Manufacturers versus Distributors
> 50% raw material components from manufacturers
Directive
•
Further minimize use of distributors where possible
7. Operational Excellence
Industry Best Practices
•
Supply Continuity
Risk Mitigation
Baseline
•
69% dual sourced
Custom
Total
289
153
442
289
153
442
100%
Secondary
•
Standar
d
Primary
Dual Sourcing
2.
200
105
305
69%
Single Source
(%)
31%
31%
43%
31%
Raw Material
Part Number
Dual Sourcing
Table 2. Primary versus Secondary Sources
Directive
•
Percent
(%)
Continue to qualify secondary sources (riskbased)
9. Quality Excellence
Continuous Improvement
1.
Relevant Incoming QC Testing
•
•
•
2.
Material and Vendor Qualification
•
3.
Split and implement into Supply Chain
Transparency to Tertiary Level
•
•
4.
Every receipt is tested (sampling plan)
Type and use
Annual trend analysis of incoming receipts
Good communication with manufacturers and distributors
Successful ACF raw material program
Proactive analysis of new requirements
•
Case Study
10. Quality Excellence
Case Study
Observation:
Multiple customer inquiries for non-detectable enteric
bacterial organisms <per USP 62>.
Challenge:
Requirement not currently implemented in supply
chain.
Current Study: Establish baseline data and assess feasibility of nondetectable specification for enteric bacterial organisms
1. Raw Material Supply Chain
-
2.
Initiated discussions with vendors
Analysis of current inventory
Environmental Analysis (12-month)
-
Facilities, equipment, processess and practices
11. Quality Excellence
Case Study
Lots
Lots w/
Bioburde
n Counts
Lots w/
Enteric +
Lots w/
Bioburden
Counts (%)
Fermentation
101
23
0
Extraction
15
1
0
6.7%
Synthetic
73
9
0
Study Strategy
22.8 %
12.3%
Production
Method
1.
Raw Material Assessment
- Production Method
- Supplier
- Number of Lots
2.
Baseline Data
- Where to look
- Rationale for next steps
3.
Directive
- Begin routine monitoring
Table 3: Raw Material Inventory by Production Method
•
Table 4: Raw Material Inventory Bioburden – Lots Received
Raw materials and EM
12. Raw Material Program
Functionality
Quality Group
1.
Operational Group
Material & Vendor Qualification
1.
• Sourcing Strategy
• Dual Sourcing
• Risk-based Management
2.
Change Notification
Challenge
Supply Chain Implementation
• Sourcing Strategy
• Dual Sourcing
• Risk-based Management
2.
Change Notification
Must Talk
Must Respond
Steering
Committee
Execution
13. Raw Material Program
Steering Committee
Manufacturing Operations
Technical Support
Supply Chain
Quality Assurance
Quality Control
Technical Support
Sales and Marketing
Best Practices
Continuous Improvement
Seamless Integration
1. Qualification Requirements
2. Change Notification
3. Incoming QC Testing
1. Customer Requirements
2. Market Trends
1. Supply Chain
Implementation
2. Change Notification
3. Relevant Testing
14. Service Excellence
Seamless Integration – Custom Needs
1.
Custom Documentation Requirements
•
2.
Inventory Management
•
•
3.
Raw material documentation
Sequestered Inventory - Critical Raw Materials
Master Raw Material Lists / Requirements
Transparency to Tertiary Level
•
•
Troubleshooting
Change Notification
15. Raw Material Program
Conclusion
1.
Ensuring Alignment with Industry Expectations
•
2.
Practical Approach to Our Business
•
3.
Proactive versus reactive
Risk-based management
Ensuring Execution
•
Business Continuity
16. Acknowledgement
Jim Niemeyer
Alma Krebs
Holden Harris
Ashley Werner
Tom Fletcher
Erik Vaessen
Deb Stutz
Director of Operations
Manager, Supply Chain
Manager, Quality Assurance
Manager, Quality Control
Director, Research & Development
EU Territory Business Manager
Director, Marketing
Notas del editor
Thank you all for being here today, I am very excited to be here, to present our raw material sourcing and management program. As Quality Director, I am very passionate about this subject and I know from experience that many in the cell culture industry share the same passion with me. We deeply believe that raw material and it’s management play a very critical role at the reducing risk during the manufacturing of biopharmaceuticals.
Many of you are familiar with Irvine Scientific and some might not be, so I will present a brief introduction of our company and an overview of our recently formalized raw material program, historical events, program elements, which includes quality, operational and Service and I will conclude with an explanation as to why we decided to formalized our raw material program.
IS is a cell culture media company. Established in 1970 originally as a serum supplierwithin a few years expanded the product offering to include cell culture productsToday, we are cell culture media supplier and that is what we do, it is the sole business of our organizationAs a media company we serve three markets the Biopharmaceutical for Industrial Cell Culture applications, the medical market with ART products, and the cell therapy with specialty media. Our parent company JX Holding with headquarters in Japan.
Many of us are familiar with the historical events that have taken place with contaminated products by an unexpected contaminants.We know that the evolution with the raw material requirements have been driven by industry impacting events. We recognized the importance to address risk whether actual or potentialWe have gain perspective and understanding basically not only what can go wrong, but learning what can we do to prevent it. Those responsible for Cell Culture manufacturing process are concerned with the risk of process contamination and we as media supply partner play a role at minimizing the risk.
I was talking about raw materials controls and concerns over 10 years ago… Issues associated with raw materials and the supply chain is a topic here to stay. Last year we decided to take a more integrated approach to managing current and potential challenges with raw material supply (both for us and our customers) by creating an internal program called ‘The Raw Material Program. While we have always had the operational and quality elements as they relate to raw material management, our program now takes a more integrated approach. I’ll now walk you through each of the three major components of our program which incorporates best practices, a continuous improvement approach, and integration of custom requirements.
Operational: I am going to talk about three top priority. The first priority we identified, was sourcing strategy, which impacts our ability to manage toward this transparency and is therefore our first priority within the program. The first thing we did was assess how the status of manufacturers vs. distributors with our raw materials We manage our raw materials in two categories – Irvine Scientific’s general inventory and inventory dedicated to specific customer requirements. This table provides an example of our approach, which was to have a clear understanding of what we had in terms of direct manufacturers and distributors. Knowing where we were starting, our internal directive is to further our use of direct manufacturers where possible.
The second operationalstrategy:Dual sourcing, ensures supply continuity and is a preventive measure to avoid production delays. It was very important to understand where we were at in terms of single and secondary sources, a analysis was completed to understand our base line.
The supply chain is the third critical priority in our program it was something in existing and for this part we are very strong, this operational functionality if is very robust5 key elements: Supplier qualification, material qualification, Change notification, purchasing controls and inventory controls. While they currently exists and operates in a robust manner, the objective of our program is to continue to focused in a risk based management.
Relevant Incoming QC: testing by type and how the raw material is used, it’s impact in the final product, Industry accepted sampling plan ANSI.Z1.4 Normal of ISO 2859Material and vendor qualification:Transparency to Tertiary LevelGood Communication with manufactures and distributors That is what allowed us to implement a succesfull ACF raw material program, part of the program is to certified all the components have to be certified by the suppliers free of animal component to the tertiary level of exposure. TL= Primary animal tissue, secondary animal enzyme in the mfg process, tertiary exposure, the enzyme is not animal derived, but there was exposure during the production of the enzyme As a custom media partner we have a very unique advantage, we received many request from our customers and with this have the opportunity to learn new requirements. In a moment I will present a case study that was generated from a custom request. At times some industry requirements are real and sometimes might not be feasible or value added, but this is our responsibility to know.
Inquiries enteric free media. An assessment had to be done, since this type of testing was not normally performed on all raw materials and final products. Our challenge was in the supply chain, as we investigated our suppliers informed us that they were not testing for this specific organism. Steps were taken to determine current conditions of raws, environment, associated equipment and practices. Once we found where we were at we can make decisions on how to move forward.
Raw materials were chosen based on their prevalence in ICC formulations. These were tested for standard bioburden in addition to enteric bioburden.Studies showed some materials (fermentation) were more susceptible to bioburden in general, Enteric was not seen in the raw materials at all.What we learned is that some were more susceptible and that we should continue to monitor these more. The message is that for this customer their formulations we were able to implement Enteric free specification.TSAT= Trypticase Soy AgarSAB= Sabouroud Dextrose AgarVR= Violet red Bile Glucose Agar
RM functionality:Quality created a directive for the operational group, in terms of material and vendor qualification. (Sourcing strategy, dual sourcing,….) operational group must execute and integrate the direction into the supply chain.While the functionality was always there, the challenge was that the priorities were not always in alignment, therefore the execution is not always in alignment. How did we solved the challenge? We included an additional piece to the functionality technical and sales and marketing and created an internal steering committee to improve execution.
The steering committee includes operations, quality, technical, sales and marketing groups. This committee is going to assess the needs of our business, will determine priorities and strategies and ensures alignment with industry requirements and a very critical piece a seamless integration of our customer requests.
Here are some examples seamless integration of our customer requirement for custom products.
At the end of our day, we want our business to be in alignment with industry expectations. Want to take a practical approach to our business utilizing risk based and value added strategies. Ultimately our goal is to ensure business continuity and no interruption of our supply from our suppliers to our customers.
I would like to Acknowledge the steering committee team for collaborating tirelessly to the success of our Raw material program