Bora Pharmaceuticals

Having a robust Cell Line Development (CLD) strategy is the foundation of biologic production that can propel a project, helping to streamline production while mitigating risk. A tailored and optimized cell line can be instrumental in overcoming development and manufacturing challenges and achieving a competitive advantage in the market with streamlined manufacturing processes. In this eBook, Bora Biologics describes how a robust CLD strategy can help biologics developers anticipate and overcome challenges and streamline production.

Well-designed analytical testing of biologics is essential during every stage of biopharmaceutical development to ensure the safety and quality of the drug and provides an important feedback loop during development. In this article, Bora Biologics delves into the significance of rigorous analytical testing, highlighting strategies to meet regulatory standards and enhance processes effectively.

Choosing the right CDMO is a strategic decision that can significantly impact the success of biologics development. By evaluating a CDMO’s ability to adapt programs to specific protein therapies and manufacturing needs, leverage specialized expertise, offer integrated solutions and overcome industry challenges, manufacturers can make informed decisions that maximize their chances of project success. In this article, Bora Biologics explores how a strategic approach — adapting programs for specific proteins and customer needs — can be beneficial in achieving the customer’s biologics development goals for novel therapeutics or biosimilars.

Topical drug formulations often require more excipients to deliver their API payload effectively. Therefore, excipient choices impact manufacturing & commercial success.

***Session 1: Thursday, April 22, 2021, 10am EDT, Session 2: Thursday, April 22, 2021, 11am EDT, Session 3: Thursday, April 22, 2021, 1pm EDT*** A drug’s journey from development to manufacturing to patients is paved with roadblocks and potholes; many threats can derail bio/pharmaceutical processes. Potential solutions to such pitfalls have been discussed for years; however, few manufacturers have embraced technology and process advances to proactively ensure drug supply chain continuity.