BioPharm International - May 2021

BioPharm - Partnerships for Outsourcing - May 2021

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38 BioPharm International eBook May 2021 www.biopharminternational.com trial, PPS said in a company press release. The trial will evaluate the safety, pharmacokinetics, maximum tol e r at e d d o s e , a nd pr e l i m i n a r y anti-t umor activ it y of TH1902 in pa r t ic ipa nts w it h adv a nced sol id tumors refractor y to available anti- cancer therapies. "Our Lex ing ton team went the e x t r a m i l e to p r o v id e s olut ion s t o e n s u r e t i m e l y f o r m u l a t i o n development and production of the material," said DeYoung in a press release. "It's yet another example of how we are focused on working with our customers to reduce the burden of disease on patients." CDMO ALLIANCES Vet ter and Rentsch ler Biopha rma have announced the strengthening of their strategic alliance (7). Key steps for wa rd in t he CDMOs relat ion- ship include the establishment of a framework for their alliance and the setting up of a governance structure. Add it iona l ly, t he companies have implemented guidelines for their joint approach across functions. The com- panies have started their f irst joint client projects while simultaneously working closely on existing projects and related topics, it was revealed in the press release. I n i t i a t e d i n m i d -2 0 2 0 , t h e c ol l a b o r a t ion w a s a i m e d a t t h e creation of long-term value through t he a l i g n ment of ma nu fac t u r i n g approaches, which can improve time- to-market. The established framework comprises an overa l l col laboration agreement, regulating the intended contributions of both parties. Further operational agreements and guidelines between various departments, such as quality, development service, and logistics have also been implemented. These agreements provide key standards for joint approaches as well as core inputs and processes across both organizations to align interfaces and optimize services. The alignment of the departments also includes the CDMOs' global business development teams. " T he for mat ion of t he mut u a l agreements and alignment on a client approach were foundat iona l steps t hat b ot h Vet ter a nd R ent sc h ler Biopha rma identif ied ea rly in our exploration of this strategic alliance," said Peter Soelkner, Vetter managing director, in a press release. "We look forward to the new progress that this step will facilitate." " We a re ver y interested to see how the experience gained in these initial projects will further enhance o u r s t r a t e g i c a l l i a n c e ," a d d e d Frank Mathias, CEO of Rentschler Biopha r ma , in t he press relea se. "These client engagements will provide va luable insights for our teams to leverage in refining the alignment of our processes and approaches." REFERENCES 1. Catalent, "Moderna and Catalent Announce Long-Term Strategic Collaboration for Dedicated Vial Filling of Moderna's COVID-19 Vaccine and Clinical Portfolio," Press Release, April 6, 2021. 2. Humanigen, "Humanigen and Emergent BioSolutions Announce Contract Development and Manufacturing Agreement for Phase 3 COVID-19 Therapeutic Candidate Lenzilumab," Press Release, Jan. 25, 2021. 3. Sanofi, "Sanofi to Help Manufacture Moderna COVID-19 Vaccine, Supporting Global Supply Demands," Press Release, April 26, 2021. 4. Catalent, "Catalent Signs Development and Manufacturing Agreement with Trizell for Macrophage-based Advanced Cell Therapy," Press Release, Feb. 8, 2021. 5. Piramal Pharma Solutions, "Piramal Pharma Solutions Enters into a Master Services Agreement with Plus Therapeutics, Inc.," Press Release, March 23, 2021. 6. Piramal Pharma Solutions, "Piramal Pharma Solutions Announces Sterile Fill/Finish Program with Theratechnologies Inc. for TH1902 Peptide-drug Conjugate," Press Release, Jan. 25, 2021. 7. Vetter, "Vetter and Rentschler Biopharma Further Strengthen their Strategic Alliance," Press Release, April 21, 2021. BP Partnerships for Outsourcing Operations AbbVie ........................................................................................................................................................ 27 Aji Bio.......................................................................................................................................................... 17 Avid Bioservices ......................................................................................................................................... 5 Beckman Coulter ..................................................................................................................................... 11 Catalent (Biologics)................................................................................................................Cover Tip, 39 Charles River Labs .................................................................................................................................... 33 Emergent BioSolutions ............................................................................................................................ 23 Entegris ........................................................................................................................................................ 7 Eurofins Lancaster ................................................................................................................................... 31 Pfizer CentreOne ...................................................................................................................................... 25 Sartorius Biologics ...................................................................................................................................... 3 Thermo Fisher (BPD_PCS) ....................................................................................................................... 15 Ad Index COMPANY PAGE

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