11.07.24 -- I Outsource, Reluctantly

Join us on November 21st for a presentation that highlights the importance of selecting effective manufacturing strategies and the impact of global supply chain challenges on biologics. Key learning objectives include evaluating production strategies and understanding how modular designs enhance scalability and reduce risks. Click here to learn more.

Properly executing CMC management — and CMC outsourcing, in particular — mitigates risk and provides opportunities to accelerate pharmaceutical developers’ rush to clinic. Making decisions within the context of a specific therapeutic area and molecular biology, as well as securing specialized partners, helps companies generate a more accurate gap and risk assessment.

The heterogeneity of a biologic product has implications for the final therapy's safety and efficacy. Explore challenges associated with charged variants, including mAbs and fusion proteins.

Utilize these strategies to develop a functional equivalence model for single-use manufacturing equipment and assemblies for use in drug product manufacturing.

ADCs have emerged as a promising class of targeted cancer therapies. Explore linker-payload design elements, conjugation and characterization of ADCs, and the different bioassays used to screen ADCs.

In response to a 2023 Open Letter from leading pharma companies, CDMOs are determining how to adapt their SOPs to improve sustainability and reduce CO2 emissions.

As you search for a global manufacturing partner, consider the benefits of working with a CDMO based in Poland, including high quality and technical precision at an attractive cost.

Discover key considerations and challenges in implementing N-1 perfusion technology, as well as the impact of continuous technology on tech transfer and process scale-up.

Precision medicine in oncology demands a comprehensive approach, beyond genomics. Let's explore the critical role of a multi-faceted toolkit for advancing biomarker research and treatment development.

Equip your team with the tools and strategies needed to strengthen calibration efforts and better position your organization for success in regulatory audits.

Delivering high viscosity (HV) formulations with a truly human solution involves a balance between safety and practicality. Learn the importance of achieving this solution with HV autoinjector design.

Incorporating adjuvants like aluminum salts into vaccines has its benefits, but it's crucial to understand the challenges these formulations present to ensure a successful partnership with a CDMO.

Ensuring container closure integrity in an increasingly complex pharmaceutical industry requires a holistic approach that incorporates quality control into all phases of product design and development.

Cytiva Supor Prime filters, designed for high-throughput antibody drug manufacturing, minimize product loss and waste, ensuring optimal yield in revolutionary treatments.

See how an advanced Cell Line Development (CLD) platform enhances CHO-based biologics development with high-yield stability, bottleneck reduction, and comprehensive genomic verification.

Designed to deliver effective IND-ready GMP material for biopharma developers, AGCellerate offers guaranteed amounts at fixed timelines and costs.

Simon Westbrook formed Levicept to develop an idea for a complex fusion chimera protein he believed could interrupt the neurotrophin pathway, and being a true virtual company, he needed a CDMO.

With services to develop and scale up Probiotics, Postbiotics and Microbial Therapeutics, uncover how Sacco System’s capabilities can help take your drug product to market safely and efficiently.