PD_Packaging Digest

Packaging Digest, Fall 2016

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34 BEST PRACTICES // FALL 2016 www.PackagingDigest.com Contract manufacturing and packaging help bring orphan drug to market Amicus Therapeutics Inc. has been working with The Almac Group FROM PHASE III CLINICAL TRIALS THROUGH COMMERCIALIZATION of Galafold. Daphne Allen, Executive Editor, Pharmaceutical & Medical Packaging News Galafold was recently approved in Europe as a f rst-line, long-term monotherapy for Fabry disease in patients with amenable mutations. T e Almac Group (www.almacgroup.com) has helped Amicus T erapeutics Inc. with Galafold's packaging along the way, f rst working with the drug company in 2009 when it needed an outsourcing partner for Phase III clinical manufacturing and packaging of its solid oral AT1001 compound. Almac's Pharmaceutical Development and Clinical teams have continued to work with Amicus to advance the drug product through scale up, registration, and now into commercial supply. "Providing quality drug product and suffi cient drug supply is critical to ensuring a successful launch of Galafold for Fabry patients who have an amenable mutation," said Enrique Dilone, Ph.D., RAC, svp, technical operations at Amicus T erapeutics Inc., in a statement. "Almac has been an outstanding outsourcing partner for Amicus, and we look forward to continuing the relationship as Galafold becomes available across the EU." To support Galafold's launch across Europe, Almac manufactures and packs Galafold at its United Kingdom commercial facility in Craigavon, Northern Ireland. Considered an orphan drug, Galafold is supplied as an immediate-release hard capsule in PVC- PCTFE-PVC/Al blisters contained in a wallet/ Dosepak presentation, explains Stuart Hunter, packaging design manager, Almac Group. "With a dosing regimen of one capsule every other day, patient compliance was a key requirement when the f nal pack format was being designed. Child resistance and senior-friendly packaging was also required." Hunter tells PMP News that the blister/wallet design used throughout the clinical studies evolved Skin Pack Films SUR-FLEX ® MS-78 CUSTOM SIZES – Sur-Flex ® ionomer JTUIFQSFNJFSmMNGPSTLJOQBDLBHJOH1SPWJEFTIJHIHMPTT IJHITUSFOHUIGBTUDZDMFOPCPBSEDVSMBOEIJHIQVODUVSF SFTJTUBODF SUR-FLEX ® MS-78 IMMEDIATE SHIP – One roll to NVMUJQBMMFUTPGBMMQPQVMBSTJ[FT*/450$,/08þ SUR-FLEX ® MS-78 – CX01 NON-WET LOOKo&MJNJOBUFT BJSFOUSBQNFOUQSPWJEFTBIJHIHMPTTQBDLBHF SUR-FLEX ® CONTAINMENT FILMSo'PSDPBUFEBOE VODPBUFECPBSE POLY-WRAP ® 500 & POLY-WRAP ® 242 o 4USPOH WFSTBUJMF mMNT EFTJHOFE UP VUJMJ[F DPBUFE DPSSVHBUFE TLJO CPBSEJODPOUBJONFOUTLJOQBDLBHJOHBQQMJDBUJPOT SUR-FLEX ® UC-25 o 4USPOH MJHIUXFJHIU UIFSNP BEIFTJWF mMN XJUI IJHIDMBSJUZ EFTJHOFE UP VUJMJ[F VODPBUFE DPSSVHBUFE TLJO CPBSE JO DPOUBJONFOU TLJO QBDLBHJOHBQQMJDBUJPOT Multi-Layered Coextrusion Films VERTICAL FORM SEAL FILMo*ODSFBTFTMJOFTQFFE BOETFBMTUSFOHUI THERMOFORM SEAL FILMo1FSGPSNTJOEJGmDVMUESBX SBUJPTXJUIMFTTUIJOOJOHJOUIFDPSOFST LAMINATING FILM o 0VUTUBOEJOH TFBM QSPQFSUJFT BU IJHI QSPEVDUJPO TQFFET $BO CF MBNJOBUFE UP B XJEF WBSJFUZPGTVCTUSBUFT MEDICAL PACK FILM o $PFYUSVEFE UP QSPWJEF B DPOUSPMMFESFMFBTFMBZFS Blister Pack Films BUTYRATE o 4QBSLMJOH DMFBS 67 TUBCJMJ[FE SJHJE mMN FBTJMZUIFSNPGPSNFE'PSPVUEPPSBOEJOEPPSFYQPTVSF Specialty Films SUR-FLEX ® SF-99 STRETCH PAK FILMo)JHIDMBSJUZ HMPTT BCSBTJPOBOE QVODUVSF SFTJTUBODF $PNQBSFE UP WJOZMNBUFSJBMTJUQSPWJEFTGBTUFSDZDMFUJNFOPQMBTUJDJ[FS DBSSZPWFSIJHIFSZJFMEBOEBMPXFSDPTUQFSQBDLBHF PROTECT-O-SHEET ¨ PS-902o$MJOHNBTLJOHmMNGPS BDSZMJDTIFFUBOEOPOQPSPVTTVSGBDFT1SFWFOUTEBNBHF BOETPJMJOHPGTIFFUJOIBOEMJOH POLY-RIB ¨ o'MPPSPSTIFMGSVOOFSXJUITNPPUICBDLPS SJCCFECBDL POLY-COVER ¨ o UP NJM QPMZFUIZMFOF mMN VQ UP GFFUXJEFDMFBSPSCMBDL FLEX-O-CRYLIC ¨ o$SZTUBMDMFBS BDSZMJDTIFFU FLEX-O-BAG ¨ CONTRACTOR BAGSoNJM)FBWZ%VUZ (BMMPOTJ[FT VISIT US AT BOOTH E-7906 PACK EXPO 2016 • NOV. 6–9, 2016 FLEX-O-GLASS, INC. 1100 N. Cicero Ave. Chicago, Il 60651 800.621.3345 ext. 226 sales @ ¾I\SKPEWWGSQ [[[¾I\SKPEWWGSQ TOP QUALITY PLASTICS Stock & Custom Film Extrusion Since 1956 Patient compliance was a key requirement for design. Almac has helped Galafold scale up to commercial supply. The wallet has capacity for serialized data to be applied.

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