DME Facility Focus 2018: GMP Facility Flexibility Question Title * 1. What is your primary affiliation? Biologics/Biopharm Pharmaceutical Both (Pharma/Bio) Generics CMO/CDMO/CPO/CRO Nutraceuticals/Vitamins Medical Device Animal Health Regulatory Authority Consultant Vendor Other (please specify) Question Title * 2. Which best describes your facility’s primary area of cGMP manufacturing? Biopharmaceuticals Vaccines Blood Products HCT/Ps Small Molecule Drugs Diagnostics Sterile Drug Product Non-Sterile Fill/Finish Packaging & Labeling Not Applicable Other Manufacturing (please specify) Question Title * 3. What aspect of GMP facility flexibility do you consider the most valuable? (check one) Ability to easily expand or repurpose manufacturing space Ability to produce multiple products with quick changeover Ability to accommodate both large and small volume production requirements Ability to easily adapt the facility to new products and manufacturing processes Ability to convert between clinical manufacturing and commercial production Question Title * 4. If you could change one thing in your current GMP facility to make it more flexible, what would it be? (check one) Greater facility segregation (more isolated processing suites) Less facility segregation (consolidated processing suites; ballrooms) More segregated utilities (e.g. HVAC, clean utilities) Ability to accommodate more varied utility loads More space in processing suites More staging/storage space More process support capacity (e.g. sterilizers, glasswash, CIP) Not applicable Other (please specify) Question Title * 5. What is the most important benefit of facility flexibility for GMP operations? Capability to accommodate process diversity Greater manufacturing efficiency and higher utilization Ability to accommodate future change and mitigate risk Other (please specify) Question Title * 6. In your organization, please rank the typical project priorities associated with GMP facility renovations or expansions. (rank 1-5, where 1 = highest priority) 1 2 3 4 5 Low capital cost 1 2 3 4 5 Low operating cost 1 2 3 4 5 Ability to accommodate process delivery 1 2 3 4 5 Ability to accommodate future modifications and expansions 1 2 3 4 5 Ease of regulatory acceptance Question Title * 7. What is the biggest challenge associated with multiproduct manufacturing in GMP facilities? (check one) Efficient space utilization for diverse processing Prevention of product cross-contamination Equipment sizing to maximize utilization Flexible process automation/recipe design Efficient changeover between product campaigns Other (please specify) Question Title * 8. In terms of the demands on a facility, what is the most difficult aspect of multiproduct manufacturing? Supporting diverse utility loads Material storage and movement logistics Maintaining GMP segregation and flows Scheduling downtime for maintenance Other (please specify) Question Title * 9. What do you consider the most useful technology to improve facility flexibility Modular construction Process automation Single-use technology Continuous processing Other (please specify) Question Title * 10. In what areas of your cGMP process are you currently using single use technology exclusively (i.e., disposables in all product-contact applications)? (check all that apply) Buffer preparation Media preparation Inoculum preparation Fermentation/Cell Culture Harvest & Recovery Purification & Polishing Bulk Fill Formulation Filling Not applicable Question Title * 11. What has been your most significant challenge associated with single use technology? Integrity of Disposables Verifying Process Closure Lack of Industry Standards Process Compatibility Cost of Disposables Vendor Supply Train Process Scale Limitations Operations Mindset/Training SU Components Receiving & Storage Waste Disposal Question Title * 12. How would your company benefit if you converted all of your open GMP operations to closed processing (i.e., manufacturing under conditions where the product is never exposed to the surrounding environment)? (check all that apply) Reduced gowning requirements Lower cleanroom classifications Less facility segregation (e.g. more ballroom operations) Simplified concurrent multiproduct processing Less regulatory scrutiny No benefit to our operations Not applicable Other (please specify) Question Title * 13. Please provide contact information for award of Starbucks gift card and Facility Focus white paper. Full Name Company Email Address Done