BioPharm International - February 2020

BioPharm-Outsourcing eBook

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www.biopharminternational.com February 2020 BioPharm International eBook 29 facility in Anagni, Italy in January 2 0 2 0 (2). T he 2 8 ,0 0 0 - s qu a r e - m e t e r ( 3 0 5 , 0 0 0 - s q u a r e - f o o t ) facility offers aseptic liquid and powder filling for biologics and sterile products for multiple vial sizes, and primary and secondary packag ing solut ions, includ ing serialization, to support product launches for oral solids, sterile, and biologics products. Catalent has also revealed that it plans to make further investments in the site's growth, the company said in a press release. "The Anagni facility supplements our European commercial supply capabilities and will integrate well w it h our ex ist ing globa l ea rly development and clinical supply sites to smoot h t he t ra nsit ion from development to commercial supply," said Alessandro Maselli, C ata lent 's president a nd ch ief op erat i ng of f icer i n t he press statement. "Anagni provides our European customers w ith great biologics and oral dose capabilities that can help us reduce time-to- market, simplif y tech transfers, and minimize program risk." Additionally, Catalent announced it was investing $9 million into a new clinical supply facilit y in San Diego, CA that will begin operations in the summer of 2020 (3). According to a Sept. 5, 2019 press release, t he new fac i l it y w i l l p r o v i d e c l i n i c a l s u p p l y ser v ices to pharmaceutical and b i o p h a r m a c e ut i c a l c u s t o m e r s a nd w ill spec ia li ze in ser v ices for ea rly pha se c l i n ic a l t r ia l s while enhancing the company's OptiForm Total Supply ser v ice, which offers customers integrated d e ve lo p me nt , c l i n ic a l s up p l y manufacturing, and distribution. T he f ac i l it y w i l l a l s o h a nd le c l i n ic a l s up p l y m a n a ge m e nt , primary and secondary packaging, complex labeling services, clinical storage, distr ibution, and dr ug returns and destruction and will include stability chambers. O n J a n . 2 2 , 2 0 2 0 , T h e Discovery Labs, an MLP Venture company and provider of cGMP manufacturing, turnkey laboratory s o l u t i o n s , c r i t i c a l m a t e r i a l s , and office space, and Deerfield M a n a g e m e n t , a h e a l t h c a r e i nvest ment ma nagement f i r m, announced that they have formed T he C e nte r for B r e a k t h roug h Medicines, a specialty investment c omp a ny (4). Und e r t he ne w C D M O, t h e c o m p a n i e s w i l l i nvest $1.1 bi l l ion to bu i ld a manufacturing facility for cell and gene therapies. "The Center for Breakthrough M e d i c i n e s w i l l b e s e r v i n g companies from the earliest stages through commercialization. Its exceptional scale and offering will quick ly relieve t he produc t ion bottleneck for advanced therapies by reducing the time, complexity, and cost of commercializing vitally needed gene and cell therapies," noted Audrey Greenberg, board member and executive managing director for The Discovery Labs, in a company press release. PARTNERSHIPS L o n z a r e v e a l e d i n O c t o b e r 2019 that it was extending its p a r t ne r s h ip w it h G e n m a b, a D e n ma rk- ba se d biote c h nolog y c o m p a n y s p e c i a l i z i n g i n a n t i b o d y t h e r a p e u t i c s f o r c a n c e r, t o c o v e r p r e c l i n i c a l a nd c l i n ica l development a nd manufacturing for a significant p or t ion of G e n mab's pip e l i ne (5). The companies have been in collaboration since 2002. The agreement aims to provide Genmab with security of supply and to enable Genmab to move rapidly into clinical manufacturing w it h t he f le x ibi l it y needed to ma nage a n e x tensive pip el i ne through the demands of clinical t r i a l s . I t w i l l a l s o i n c l u d e developing complex molec u la r formats using Genmab's DuoBody technology. L o n z a a l s o e nt e r e d i nt o a pa r t ne r sh ip w it h Cr yop or t i n November 2019 to strengthen its 'vein-to -vein' deliver y net work b y r e m o v i n g s u p p l y c h a i n h u r d l e s f a c e d b y d e v e l o p e r s o f p e r s o n a l i z e d t h e r a p e u t i c s (6). The new collaboration will aim to provide f ully integrated solutions, including co-location of manufacturing bioservices and distribution facilities, automated data management, and process optimization. " T h e L o n z a - C r y o p o r t collaboration is an enabling part of a wider goal for Lonza to create a network of strategic partnerships and capabilities that enable seamless vein-to-vein delivery of cell and gene therapies for its customers and their patients," said Alberto Santagostino, SV P head of Cell & G e ne Te c h nolo g ie s , L o n z a Pha r ma & Biotec h, i n a press release. "There is no doubt that t his pa r t nership enables us to provide a best-in-class solution to cell and gene therapy companies for ma nu fac t u r i ng a nd supply cha i n ser v ices, a l low i ng us to provide a fully integrated solution that reduces risk and increases transparency." Additionally, Lonza announced on Jan. 28, 2020 that it is expanding its clinical manufacturing agreement with New York City-based Rocket Pharmaceuticals for the development and manufacture of RP-L201, a Phase I/II candidate for the treatment of leukocyte adhesion deficiency-I (L A D -I), a disorder that causes rec u r r i ng a nd fata l i n fec t ions during childhood (7). Outsourcing Resources Operations

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