Table of Contents - Baxter BioPharma Solutions

1 Page 1 of 19 BioPharma Solutions Product QuestionnaireBioPharma Solutions Product QuestionnaireProduct QuestionnaireLet us help you find the SOLUTION for your product needsThis product questionnaire has been designed to help you initiate a successful transfer of your product/process to an appropriate Baxter manufacturing fill out the applicable sections for your of ContentsContact Information ..2 Product Information ..3 Identification and Description ..3 Active Pharmaceutical Ingredient (API) ..5 Additional Ingredients or Solvents ( , Excluding API) ..6 Process ..7 Compounding ..7 Bulk Material and Final Product Compatibility ..7 Sterile Filtration ..8 Formulated Product ..8 Filling ..9 Lyophilization ..9 Final Sterilization ..9 Cleaning Validation ..10 Storage, Handling, and Shipping Conditions ..10 Additional Process Information.

2 10 Analytical Testing ..11 Incoming Active Pharmaceutical Ingredient (API) ..11 Drug Product in Process Control ..11 Drug Product Release ..11 Method(s) ..12 Stability ..12 Primary Packaging ..13 Vial ..13 Stopper (Vials) ..13 Seal ..14 Syringe ..14 Plunger/Stopper (Syringes) ..15 Plunger Rod ..15 Cartridge ..15 Plunger/Stopper (Cartridges) ..16 Combi Seal ..16 Secondary Packaging and Inspection ..17 Additional Environmental Health and Safety (EHS) Information ..18 Page 2 of 19 BioPharma Solutions Product QuestionnaireContact InformationCompany Name and AddressPrimary ContactSecondary ContactCompany name:Address:City:State:Zip:Country:Web site:Last name:First name:Department/title:Phone:Fax:E-mail:L ast name:First name:Department/title:Phone:Fax:E-mail:D ate:Page 3 of 19 BioPharma Solutions Product QuestionnaireFDA application status: IND PLA NDA ANDA PMA Other:FDA application registration number:What is the intended use for this product?

3 Preclinical Studies Cl Phase I Cl Phase II Cl Phase III CommercialWhere are the clinical studies performed? USA Japan Europe Other:What are the target markets? USA Japan Europe Other:Product name:Generic name:Formulation strength(s):Attachment:Please attach Material Safety Data Sheet (MSDS) and/or Toxicology Studies, Investigational Brochure, Safebridge market launch date:Annual units:Proposed batch size:Project start date:When are the first batches required?Product type: Liquid Lyophilizate Powder Sterile crystallizate Suspension/EmulsionProduct indication:Application/Use:Product InformationIdentification and DescriptionIdentificationTimelineForecas tDescriptionRegulatory RequirementsPage 4 of 19 BioPharma Solutions Product QuestionnaireForecast (continued)First year:Comment:Second year:Comment:Third year:Comment:Fourth year:Comment:Fifth year:Comment:Identification and Description (continued)Page 5 of 19 BioPharma Solutions Product QuestionnaireAPI name:Chemical name:Chemical abstract number:Exposure limit/Band:OEL: /m3 or OEB (Occupational Exposure Band): class /4 For additional information, please refer to the chart on page cost: perIs API sterile?

4 Yes NoAPI container size:API container type:Physical properties: Liquid Solid Frozen Density: g/mLHygroscopic? Yes NoElectrostatically chargeable? Yes NoInert atmosphere required? Yes NoInert gas used:Light sensitive? Yes NoCritical wavelength:Temperature sensitive? Yes NoAPI storage temperature:Maximum exposure time at room temperature (RT):Comments:Active Pharmaceutical Ingredient (API)IdentificationGeneralPhysical PropertiesPage 6 of 19 BioPharma Solutions Product QuestionnaireName:Quality/Grade: EP USP JP Other:Supplier (if a special one is required):Name:Quality/Grade: EP USP JP Other:Supplier (if a special one is required):Name:Quality/Grade: EP USP JP Other:Supplier (if a special one is required):Name:Quality/Grade: EP USP JP Other:Supplier (if a special one is required):Name:Quality/Grade: EP USP JP Other:Supplier (if a special one is required):Name:Quality/Grade: EP USP JP Other.

5 Supplier (if a special one is required):Additional Ingredients or Solvents ( , Excluding API)Ingredient/Solvent 1 Ingredient/Solvent 2 Ingredient/Solvent 4 Ingredient/Solvent 3 Ingredient/Solvent 5 Ingredient/Solvent 6 Page 7 of 19 BioPharma Solutions Product QuestionnaireBulk Material and Final Product CompatibilityProcessWe assume that your product is compatible with stainless steel (316L), glass, nylon, silicone, polycarbonate, polysulfate, PE, PP, PTFE, and EPDM. If your product is not compatible with these materials, please specify:CompoundingCompounding takes place in: Stainless steel vessel Glass vessel Disposable bag (polyethylene)Compounding solution:Name of Ingredient/SolventConcentration in bulk solution [mg/mL]FunctionBatch size (L):Viscosity (cps):Density (g/mL):pH range:Temperature range ( C):Bulk solution holding time (h):Can the product be formulated one day prior to filling?

6 Yes NoAttachment:Please attach a compounding process description excipients are USP grade? No YesPage 8 of 19 BioPharma Solutions Product QuestionnaireProcess (continued)Formulated ProductIs an inert atmosphere required? Yes NoGas used:Light sensitive? Yes NoCritical wavelength:Shear sensitive? Yes NoMoisture sensitive? Yes NoTemperature sensitive? Yes NoMaximum exposure time at room temperature:Please list any stability issues related to this product ( , freeze-thaw sensitive, protein aggregation):Sterile FiltrationAseptic filling: Yes NoFilter for pre-filtration: Millipore Pall Sartorius Other supplier:Filter type:Pore size ( m):Catalogue number:Is this filter validated? Yes NoFilter for sterile filtration: Millipore Pall Sartorius Other supplier:Filter type:Pore size ( m):Catalogue number:Is this filter validated?

7 Yes NoPage 9 of 19 BioPharma Solutions Product QuestionnaireProcess (continued)Final SterilizationTerminal sterilization: Yes NoTerminal sterilization method: Steam OtherIf other, please describe (irradiated products can be shipped to a contract sterilization facility, if required):LyophilizationCycle time (h):Minimum shelf temperature ( C):Maximum shelf temperature ( C):Maximum cooling rate ( C/min):Maximum heating rate ( C/min):Minimum vacuum:Shelf temperature during loading ( C):Collapse temperature ( C):Target residual moisture (%):Unloading temperature ( C):Reconstitution volume (mL):Reconstitution solvent:Attachment:Please attach a lyophilization cycle fill volume (mL):Upper/lower warning limit (+/- mL):Upper/lower action limit (+/- mL):Filling temperature ( C):Nitrogen flushing: Yes NoTime limit for filling (h):Time limit for units at room temperature (h):Page 10 of 19 BioPharma Solutions Product QuestionnaireCleaning ValidationStorage, Handling, and Shipping ConditionsList the LD50 value and the animal species tested ( , IV mouse):Route of application:Normal therapeutic dosage:Minimum daily dose:Maximum daily dose:Solubility in water (mg/mL):Solubility in ethanol (mg/mL):Solubility in isopropanol (mg/mL):Data for other solvents:Labeling and packaging ( C):Drug product storage ( C):Shipping ( C):Additional Process InformationPlease provide us with the specific process needs for your :Please attach executed batch record or process flow (continued)Page 11 of 19 BioPharma Solutions Product QuestionnaireOnly mark the tests that need to be performed by Baxter .

8 Indicate if the method needs to be validated/transferred: Specification attached Identity by: Specification TBD Appearance Purity by: pH Color Assay by: Clarity of solutionOnly mark the tests that need to be performed by Baxter . Indicate if the method needs to be validated/transferred: Appearance Concentration/Assay pre-filtration by: pH bulk solution (pre-filtration) pH bulk solution (post-filtration) Concentration/Assay post-filtration by: Endotoxins of compounding solution Microbial purity of compounding solution Other (please specify): Endotoxins of bulk solution to sterile filtration Bioburden of bulk solution prior to Other (please specify):sterile filtrationComments: Validation Transfer Validation Transfer Validation Transfer Validation TransferAnalytical TestingIncoming Active Pharmaceutical Ingredient (API)Only mark the tests that need to be performed by Product in Process ControlActive Pharmaceutical Ingredient (API): Specification attached Specification TBDTest according to.

9 EP USP JP Company supplied methodologyID testing method: IR UV HPLC GC Other:If other, please specify: Validation of analytical method Transfer of analytical methodSatellite sample included: Yes NoAdditional information:Drug Product Release Validation Transfer Validation Transfer Validation TransferPage 12 of 19 BioPharma Solutions Product QuestionnaireAnalytical Testing (continued)Does Baxter need to perform stability studies? Yes NoStandard testing duration (months): 12 24 36 48 60 Other:Which climatic zones should be covered? I II III IV Other:Accelerated testing duration (months): 3 6 12 18 Other:Under which conditions?Has an expiration date been established for this product? Yes NoIf yes, please describe:Additional comments:Attachment:Please attach a stability program mark the tests that need to be performed by Baxter .

10 Indicate if the method needs to be validated/transferred: Other (please specify): Other (please specify): Other (please specify):Comments:Drug Product Release (continued)Stability Validation Visual particles Validation W ater content (Karl Fischer) T ransfer Particulate matter Sub-visual particles Residual solvents Tr ansfer Bacterial Endotoxin Test (Must be validated by Baxter on 3 product batches) Validation Transfer Validation Transfer Validation Transfer Test for Sterility (Must be validatedby Baxter on 3 product batches)Method(s)Please describe or attach a copy of analytical method(s):Attachment:Please attach a copy of analytical method(s).Page 13 of 19 BioPharma Solutions Product QuestionnaireSize: DIN ISO US Format Other:Catalogue number:Supplier:Glass (USP Type I, II, or III):Type: Molded Tubing Flint (clear) Amber Untreated SO2 treated (tubing only) Other:Certificate according to: EP USP JPComments/special requirements:Vial opening: 13 mm 20 mm Other:Blowback feature: Yes NoAttachment:Please attach a drawing, specification, or certificate :Mold number:Coating:Type:Supplier:Contact:Pre -siliconized: Yes NoSilicone level (if applicable):Certificate according to: EP USP JPSilicone treatment may be required for optimal seating of the stopper.