BioPharm International - May 2021

BioPharm - Partnerships for Outsourcing - May 2021

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36 BioPharm International eBook May 2021 of lenzi lumab, Humanigen's anti- hu ma n g r a nu loc y te mac ropha ge- colony stimulating factor monoclonal a nt ib o dy for t he pre vent ion a nd t re at ment of a n i m mu ne hy p er- response associated with COVID-19 called the "cytokine storm" (2). Through the agreement, Emergent w i l l u s e it s CDMO s e r v ic e s to manufact ure dr ug product batches at its Baltimore, Md., drug product manufacturing facility to support the increased supply of the therapeutic c a n d i d a t e i n a n t i c i p a t i o n o f a potential emergency use authorization in the f irst qua r ter of 2021. The partnership will also offer access to manufacturing capacity reserved for and provided by the US government u n d e r Hu m a n i g e n's c o o p e r a t i v e research and development agreement with the Department of Defense's Joint Program Executive Off ice for Chemical, Biological, Radiological, and Nuclear Defense, in collaboration w it h t h e B i o m e d i c a l A d v a n c e d Research and Development Authority. "Drug product manufacturing is a hallmark capability of our CDMO services, and we stand ready to harness our expertise to advance lenzilumab, Humanigen's COVID-19 therapeutic candidate," said Syed T. Husain, senior vice-president and CDMO business unit head at Emergent BioSolutions, in the press release. "Every second counts in the fight against COVID-19, and we are proud that Humanigen trusts us to rapidly deploy our clinical-to- commercial manufacturing operations to fulfill the urgent need for COVID-19 therapeutic options." Sanofi announced an agreement with Moderna to aid in the manufacture of Moderna's COVID-19 vaccine (3). Accord i ng to a compa ny pre ss release, Sanof i will perform the f ill/ f inish of up to 20 0 mil lion doses of the vaccine at its Ridgef ield, NJ, facility starting in September 2021. S a n o f i h a s a l s o p r o v i d e d manufacturing support to BioNTech for 125 million doses of its COVID- 19 vaccine for the European Union and Johnson & Johnson for 12 million doses per month of its single-shot COVID-19 vaccine. Additionally, the company continues to develop its own COV ID-19 vaccine programs using the same recombinant protein-based manufacturing technology as one of its seasonal inf luenza vaccines, combined with Gla xoSmithK line's pandemic adjuvant platform. " S i n c e t h e b e g i n n i n g o f t h e pandemic, we have been mobilizing on multiple fronts and we showed solidarity across the industry," said Paul Hudson, CEO, Sanofi, in a press release. "We are one of the few pharmaceutical companies to leverage many industrial partnerships to improve global supply and access to COVID-19 vaccines, while in parallel, also continuing to develop our two COVID-19 vaccine programs." CELL AND GENE THERAPIES Catalent has entered into an agreement with Trizell to manufacture Trizell's Phase I cell therapy for the treatment of micro- and microangiopathies (4). Development of the cell therapy will take place at the University Medical Center Schleswig Holstein, Department of Anesthesiology and Intensive Care Medicine, the Clinic for Applied Cellular Medicine, and the Department of Ca rd iovascu la r Su rger y, whi le the manufacturing will take place at Catalent's facility in Gosselies, Belgium. "Our relationship with Trizell will build on Catalent's deep knowledge in immunotherapies, from the diagnosis and de-risk stage all the way through to commercial-ready processes," said Ma nja Boer ma n, Ph D, president, Catalent Cell & Gene Therapy, in a pre s s re le a s e . " E x tend i n g i nto areas such as macrophages allows us to stay on the forefront of emerging i nd ic at ion s a nd c e l l t y p e s . T he process development, manufacturing e x p e r t i s e , a n d t h e e x p e r i e n c e d production teams we have at Gosselies will enable a faster transition from development to manufacturing." DEVELOPMENT AND MANUFACTURING COLLABORATIONS Pirama l Pha rma Solutions (PPS), Piramal Pharma Limited's CDMO, has entered into a master services agreement with Plus Therapeutics, a US-based clinical-stage pharmaceutical company, under which Piramal will offer develop- ment, manufacture, and supply services for Plus Therapeutics' rhenium nanoli- posome (RNL)-liposome intermediate drug product (5). Under the terms of the agreement, t r a n s f e r of a n a l y t ic a l m e t ho d s , d e v e l o p m e nt of m ic r o biol o g ic a l m e t h o d s , p r o c e s s t r a n s f e r a n d opt i m i z at ion , i nter me d i ate d r u g product manufacturing, and stability studies will be performed at PPS' drug product facility in Lexington, Ky. The companies will aim to establish clinical and commercial supply agreements for the drug product at the appropriate stage of development through the agreement. " We are excited to partner with Plus Therapeutics. We believe that this represents the start of a long, collaborative, and mutually beneficial relationship that w il l address our ultimate objective of reducing the burden of disease on patients," said Pe t e r D eYo u n g , C E O, P h a r m a Solutions, Piramal Pharma Limited, in a press release. P P S a l s o a n n o u n c e d t h a t i t w i l l p r o v id e T h e r at e c h nol o g ie s , a C a n a d i a n b i o p h a r m a c e u t i c a l company, with good manufacturing p r a c t i c e (G M P) m a n u f a c t u r i n g of ster i le f i l l /f inish d r ug product t o s u p p o r t T H 19 0 2 (d o c e t a x e l c o n j u g a t e) , T h e r a t e c h n o l o g i e s ' peptide-drug conjugate developmental product, as it enters into a f irst-in- humans clinical study (6). Clinical material for the product will be produced at PPS' Lexington facility to be used in a Phase I clinical Partnerships for Outsourcing Operations

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