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Biologics

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Flexible and integrated solutions for biologics development and cGMP manufacturing

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From cell-line, process and formulation development and analytical services to clinical cGMP manufacturing and fill/finish, Bora Biologics provides end-to-end and tailored development and manufacturing services to biologics developers. Bora has the capability to deliver high-yield processes and the program management needed to launch even the most challenging molecules successfully.

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Read our article to explore the challenges and strategies involved in developing biologics, emphasizing the importance of tailored programs, specialized expertise, and cohesive teams for navigating regulatory complexities and manufacturing demands.

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Cell Engineering – Developing protein therapeutics is difficult because they are highly complex molecules that are grown by living cells cultured and cultivated in a precise, reproducible fashion. At Bora Biologics, we have mastered the art and science of cell engineering, cell culture, and protein purification.

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Key Features 

• • Segregated USP/DSP
  • 4 x 500L bioreactors
  • Gowning facilities
  • Separated post viral processing
  • Clean utility systems (WFI/CS/CA)
  • HVAC systems and controls

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Platform – As a top CDMO, we have a platform approach to developing biologics that allows us to perform all activities needed to transform biologics from concept to clinical product in-house.

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Facility capabilities

• • Segregated upstream and downstream processing areas
  • Segregated media buffer preparation and holding areas
  • A two-suite purification area for pre-/post-viral processing and bulk filling

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Bringing CMC program design and operational expertise to our partners to ensure late stage success to commercial

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The experienced biologics team are highly skilled experts at guiding biologics programs from their earliest stages, through development and on to patients as efficiently as possible.

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