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PDA New England Chapter Proven Strategies for Successful Transfer and Manufacture of your Injectable Drug Product with a CMO

Mar 20 - Mar 20, 2019
Bedford, NH

  • Chapter
Closed
Program Highlights

After registering for the Dinner Meeting, use the link to register for the MFR and/or QC tours with your PDA Global ORDER NUMBER and ORDER DATE.

Overview

Tour: MULTI-PRODUCT ASEPTIC MANUFACTURING SITE

Don’t miss this unique opportunity to visit LSNE’s multi-product aseptic drug product manufacturing facility located at 25 Commerce Drive in Bedford, NH. One of four cGMP production sites, the 25 Commerce aseptic manufacturing site features liquid and lyophilized drug product fill/finish capabilities for both clinical and commercial drug product. The ISO-5 aseptic fill suite houses two lyophilizers (270 and 36 square feet) and can accommodate fills of up to 25,000 units. LSNE sets itself apart by offering lyophilization of products formulated with organic solvents and a dedicated ISO-5 formulation suite for products that cannot be terminally sterilized or sterile filtered.

Tour: QC LABORATORY AND VALIDATED STORAGE FACILITY

This is your chance to visit LSNE’s new Analytical/Micro Labs and Validated Storage Center located at 7 Commerce Drive in Bedford, NH. The new analytical labs opened in 2018 and support in-process, release, and stability testing for all four of LSNE’s manufacturing sites. LSNE’s analytical team can develop or transfer your product specific assay and validate the method appropriately based on its stage of development. The new Validated Storage Center features: 80,000 cubic feet of controlled RT storage, Pallet racking for up to 300 pallets, 2-8°C and -20°C walk in units, combination drive-in 2-8°C with connecting -20°C unit. Validated and alarmed storage units have fully redundant refrigeration systems and power.

Tour Notes:

  1. All tours run for 30 minutes in length.
  2. No picture taking is allowed. 
  3. Participants will don booties for one part of the tours.
  4. Tour participants should park and check in at 29 Commerce Drive, Bedford, NH.
  5. If you are registering for both tours, please ensure that you leave time between your first tour and second tour so they don't overlap.

Not a member of PDA? Join today to attend this meeting for free!

Agenda

    • 4:00 p.m. - 5:30 p.m. Multi- Product Aseptic Manufacturing Site/ QC Laboratory and Validated Storage Facility Tours begin 
    • 5:30 p.m. - 6:30 p.m. Registration, Cocktails, and Networking with Sponsors
    • 6:30 p.m. Dinner
    • 7:00 p.m. Opening Remarks and Presentations

Highlighted Speakers

Harry  Benson
Harry Benson
CAI
Shawn  Cain
Shawn Cain
LSNE Contract Manufacturing

Travel

Please read: PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

LSNE Contract Manufacturing

29 Commerce Drive
Bedford, NH

Directions

Registration Fees

Regular Price

Registration Type Price by March  15 (Noon EST) 
PDA Member $75
PDA Non-Member $95
PDA Student $10
PDA Unemployed $10
PDA Retired $10

Late Registration Price by March 15
All Attendees $115

For late registrations, contact events@ne-pda.org. Late registration payments will be accepted at the door. You can now pay for late registration with your credit card.

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