04.03.25 -- Takeda's Award-Winning Facility Teaches You About Outsourcing

Our panel of experienced biopharma executives explain the different effects on trade wars or supply-chain disruptions with Big Pharma and smaller drug development organizations.

As cost and supply come under more scrutiny, there are primarily three scaling strategies for mAb manufacturing that can be leveraged, each with its own set of pros and cons.

Review a modeling approach employing artificial neural networks using experimental factors combined with simulation-derived parameters plus viscosity data from 27 highly concentrated mAbs.

Tech Talks explore ADC development innovations, including integrated supply chains, seamless pilot-to-GMP scale-ups, and advanced process analytical technology (PAT).

In this presentation, speakers discuss the technical and regulatory considerations that arise with increasing production size and address the impact of fluctuating product demand.

Discover how companies can de-risk their device selection as they bring this new generation of high-volume, high-viscosity biologics to market.

Recognizing the increased complexity of biologic analyses, as compared to small molecule drugs, can help avoid unnecessary complications and prevent cost overruns.

Find out why it is critical that OEMs see and understand the benefits of taking time to build a mold or create automation more robustly to achieve long-term savings and higher annual production.

Explore process characterization services based on QbD principles, with an emphasis on risk and knowledge management and transforming data into the currency of product and process knowledge.

Ensure the success and stability of your lyophilized products by choosing the right container-closure system — consider your stopper options, here.

Uncover the strategies that helped a company navigate a complex and shifting regulatory landscape to rapidly re-engineer a COVID-19 vaccine manufacturing process for FDA compliance.

This advanced cell line development technology overcomes production challenges related to the expression and scalability of complex biologics.

Offering increased binding capacities compared to other resins, see why this protein L affinity chromatography resin is well suited for use in biomanufacturing.

Go on a virtual tour of our GMP-certified facility, where we uphold our expanded capabilities for large molecule development to the highest standards for clinical and commercial manufacturing.

Check out our new program designed to deliver effective IND-ready GMP material for biopharmaceutical developers, offering guaranteed amounts at fixed timelines.

Gain insights into boosting efficiency, fostering innovation, and how integrated capabilities generate value for innovators.

From early development to commercialization, we provide comprehensive support in meeting regulatory expectations for characterization, potency, stability, and safety testing of biologic drug products.

NovaPure components are designed and manufactured using Quality by Design principles to mitigate risk for the patient in every project from start to finish.