download agt facility expansion continuity plan
TRANSCRIPT
1 The world leader in serving science
Gibco’s EU AGT and AOF DPM Facility Manufacturing Continuity Planning
• Eric J. Nalbach
• Sr. Global Product Manager
• July 2014
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Advanced Granulation Technology™ (AGT™) Products
• Decision to build 2nd facility 2012 • Ground Breaking Inchinnan Mid 2013 • Facility Ready to Manufacture cGMP 2Q2015 • Investment of ~$20M USD
• AGT Launched in 2004 • Increased / long term demand
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A Overhead look at the Future AGT/AOF DPM Inchinnan Site
AGT Building
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Vertical Layout Design of New AGT/AOF DPM Facility
Milling Granulation
Pre Blend Final Blend
Packaging
*
* (300cu.ft.) / (6-7,000Kg) Blender installation slated for phase 2 of facility
• AOF Throughout Entire Facility • Gravity Fed Process • Less Handling and Human Interaction • Increased Process Efficiency
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Our 2014 – Facility Equivalence and Ease of Transfer
2x AGT /AOF DPM Facilities
Same Specification Raw Materials
Equivalent Documentation
Equivalent Manufacturing
Same Testing
Product
Solution Delivery Spray
Nozzle
Air Preparation Unit
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Benefits to Our Customers
Quality
Local Access
Lead Time
Mfg Approach
Lower Risk
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Quality: Raw Materials • Same Raw Material Suppliers for AGT Products / AOF DPM products • Moving to Multi Compendia Where Possible • Specification Upgrades
RM: L-Aspartic Acid SKU #: 720-0008 15 Tests
RM: L-Aspartic Acid SKU #: 910-1016 15 Tests
RM: L-Aspartic Acid SKU #: 910-1016 17 Tests (Bioburden and Endotoxin)
Inchinnan Spec Grand Island Spec Harmonized Spec
RM: Folic Acid Approved Vendor 1 Approved Vendor 2 EP/USP Grade
RM: Folic Acid Approved Vendor 1 Approved Vendor 3 FCC/USP Grade
RM: Folic Acid Approved Vendor 1 Approved Vendor 2 EP / USP Grade
Inchinnan RM Grand Island RM Harmonized RM
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Quality – RM and Finished Good Release
• Standardizing Finished Good Release • Using most advanced test methods
Endotoxin: Inchinnan Test Better detection limits Bioburden: Same test Cell Assay: SOP Differences Amino Acids: Both UPLC Vitamins: UPLC at IN; HPLC at GI Polyamines: HPCL at GI only
Inchinnan vs. Grand Island Spec Harmonized Spec
Endotoxin: Same test Bioburden: Revalidate for both sites Cell Assay: Same exact procedure Amino Acids: No Changes Vitamins: UPLC both Sites Polyamines: UPLC both Sites
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Media Network Specification Alignment
Ø Have reviewed a total of 208 Raw Materials that are used for AGT and AOF
Ø Of these 208 materials, a total of 180 are going through internal specification harmonization/rationalization:
• Combining on single spec ID rather than multiple ID’s
• For some Raw Materials, add additional testing to one site or the other
Ø For the remaining 28 Raw Materials, we are adopting a previously approved supplier at both sites; i.e. GI is adopting Inchinnan or Inchinnan is adopting GI suppliers
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Impact to GI Supply Chain GI to use UK source
CAS # GI DescriptionGI Formula Weight
GI Grade UK Grade Aligned GradeCompendial Upgrade
Current GI Suppliers
Current UK Suppliers
Aligned Suppliers
110-‐17-‐8 AOF FUMARIC ACID 116.07 GIBCO NF NF Y VWR/MBI Applichem Applichem
56-‐89-‐3 L CYSTINE 240.3 GIBCO EP EP Y
SAFC Cleveland/Wacker
Chemie AGAjinomoto, Applichem
Ajinomoto, Applichem
59-‐67-‐6 NICOTINIC ACID 123.11 USP EP/USP USP/EP Y Amresco DSM DSM98-‐92-‐0 NIACINAMIDE 122.13 USP EP/USP USP/EP Y Affymetrix DSM DSM77-‐92-‐9 CITRIC ACID ANHYD 192.13 USP EP/USP USP/EP Y VWR (Mfg -‐ MBI) VWR(Mfg -‐ Merck) VWR (Mfg -‐ Merck)
7791-‐18-‐6MAGNESIUM CHLORIDE 6H2O 203.3 USP EP/USP USP/EP Y VWR (Mfg -‐ MBI) VWR(Mfg -‐ Merck) VWR (Mfg -‐ Merck)
6132-‐04-‐3 SODIUM CITRATE 2H20 294.1 USP EP/USP USP/EP YFisher, VWR (Mfg -‐
MBI) VWR(Mfg -‐ Merck) VWR (Mfg -‐ Merck)
7681-‐49-‐4 SODIUM FLUORIDE 41.99 USP EP/USP USP/EP Y VWR/MBIMerck, VWR(Mfg -‐
Merck) VWR (Mfg -‐ Merck)107-‐35-‐7 TAURINE 125.14 USP GIBCO GIBCO N none Aji/Taisho Ajinomoto
6381-‐92-‐6 EDTA DISODIUM 2H2O 372.24 ACS EP/USP USP/EP Y VWR/MBI Applichem, Merck Applichem, Merck7758-‐99-‐8 CUPRIC SULFATE 5H2O 249.68 ACS/USP Reagent EP/USP USP/EP Y VWR/MBI Applichem/Mainca Applichem7782-‐63-‐0 FERROUS SULFATE
7H2O 278.01 USP EP/USP USP/EP YFisher, VWR/MBI,
Sigma Merck Merck
10034-‐96-‐5MANGANOUS SULFATE H2O 169.02 USP EP/USP/FCC USP/EP Y Fisher, VWR/MBI Merck Merck
7681-‐11-‐0 POTASSIUM IODIDE 166 USP EP USP/EP Y VWR/MBI
Applichem/Incasa, Applichem/Amphr
ay Applichem7757-‐79-‐1 POTASSIUM NITRATE 101.1 USP EP/USP USP/EP Y VWR/MBI Applichem Applichem
144-‐55-‐8 SODIUM BICARBONATE 84.01 ACS/USP EP/USP USP/EP Y UBIVWR/Merck, Ubichem Merck, Ubichem
7446-‐20-‐0 ZINC SULFATE 7H2O 287.56 USP EP/USP USP/EP Y VWR/MBI Merck Merck
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Impact to Inchinnan Supply Chain UK to use GI source
CAS # GI DescriptionGI Formula Weight
GI Grade UK Grade Aligned GradeCompendial Upgrade
Current GI Suppliers
Current UK Suppliers
Aligned Suppliers
10191-‐41-‐0 DL ALPHA TOCOPHEROL 430.72 USP GIBCO USP Y Chem Int'l/DSM Sigma DSM
56-‐86-‐0 L GLUTAMIC ACID 147.13 FCC EP FCC N
Ajinomoto Interamericano, Kyowa Hakko Ajinomoto Japan
Ajinomoto, Kyowa Hakko
12054-‐85-‐2AMMONIUM MOLYBDATE 4H20 1235.86 ACS/USP Reagent USP ACS N VWR (Mfg -‐ MBI) VWR/Merck VWR (Mfg -‐ MBI)
10326-‐27-‐9BARIUM CHLORIDE 2H2O 244.26 ACS/USP Reagent GIBCO ACS Y VWR (Mfg -‐ MBI) Applichem VWR (Mfg -‐ MBI)
543-‐80-‐6 BARIUM ACETATE 255.43 ACS GIBCO ACS Y VWR (Mfg -‐ MBI) Applichem VWR (Mfg -‐ MBI)64-‐17-‐5 ETHYL ALCOHOL 100% 46.07 USP EP USP/EP Y Pharmco VWR Pharmco
10025-‐77-‐1 FERRIC CHLORIDE 6H2O 270.3 ACS/USP Reagent GIBCO ACS YVWR (Mfg -‐ MBI),
Fisher ApplichemVWR (Mfg -‐ MBI),
Fisher
7761-‐88-‐8 SILVER NITRATE 169.87 USP GIBCO USP YVWR (Mfg -‐ MBI),
Fisher SigmaVWR (Mfg -‐ MBI),
Fisher
10025-‐69-‐1STANNOUS CHLORIDE 2H2O 225.63 ACS/USP Reagent EP ACS N
VWR (Mfg -‐ MBI), Fisher Applichem/Merck
VWR (Mfg -‐ MBI), Fisher
10043-‐35-‐3 BORIC ACID 61.83 ACS/USP Reagent ANALAR ACS Y VWR (Mfg -‐ MBI) VWR/Merck VWR (Mfg -‐ MBI)
10102-‐40-‐6SODIUM MOLYBDATE 2H2O 241.95 ACS/USP Reagent ANALAR ACS Y Sigma VWR Sigma
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Manufacturing Approach, Lead Time, and Local Access
• Closed system; Minimizing Handling • Mills and blenders connected via hard Pipe • Same sized Mills, Granulators, Blenders • Ensure similar manufacturing steps
• Local Access for European Customers • Similar time zones for real time planning • Easier Audit Schedules • Easier Shipment from the continent
• Lead times to decrease • Multi site planning and increased capacity
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Risk Mitigation and Dual Source
• 2 Production Facilities for your AGT and AOF DPM • Catastrophic event concern eliminated
• Harmonized SOP (list) • SKUs • Raw material Suppliers • Raw material testing and specifications • Batch Records • Process review and validation • Equipment review and validation • Cleaning validations • Validation – batch sizes • Homogeneity validation/testing • Packaging • Testing – in process/finished product • COA • Stability
Proposed Equivalency Package
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In Conclusion and Our Promise to You
We will by End of Q2 2015: • Fully validate our second AGT/AOF DPM facility • Reducing your supply risk • Harmonize our manufacturing processes at both sites for your ease of transfer • Equivalence package for your review • Schedule your audit ASAP for your subsequent approval of our new facility
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To Learn More and Check for Updates, please visit our Harmonization Web Page:
www.lifetechnologies.com/continuityplanning