12.05.22 -- 4 Core Values For Outsourcing

Explore the decision for selecting the right and best suited technology for formulating a complex molecule.

Securing the right plasmid for an application can be a complex endeavor. Core to this is selecting a supplier with the quality assurance protocols and GMPs to facilitate optimized plasmid production.

The new system can be leveraged to obtain significant process gains in the manufacturing pathways of advanced therapies while maintaining the flexibility of transient transfection.

Examine a case study where two 20 mm vial CCSs were compared using the DeltaCube Modeling Platform and experimentally shows the link between prediction and real performance.

To prepare allogeneic, or "donor-derived," CAR T cells for commercial scale, you must consider scale-up, aseptic processing, single-use systems, facility design, starting material, supply chain, and logistics.

This report provides a roadmap for assessing toxicological and potency risks of small molecule oncology compounds while consistently ensuring worker and patient safety.

Discover the three major challenges cell and gene therapy manufacturers are facing today and experienced insights on how to overcome them.

We demonstrate an automated, compliance-ready liquid chromatography-mass spectrometry (LC-MS) workflow for sequence confirmation of oligonucleotides and their impurities.

How much quicker and easier would it be if we could know a process’s health by looking at a single metric rather than checking hundreds of parameters?

Sponsors will see success in their CDMO partnerships by dedicating time and effort to establish a plan that identifies outsourcing drivers, selecting a model that matches company needs and resources, establishing a decision-making process and group, and designating key selection criteria. Using these steps, drug developers can build strategic outsourcing relationships where their internal expertise is complemented by external CDMO resources.

A strategic partner should seek innovation that improves your compound or product’s value. Pfizer CentreOne’s Tom Wilson shares tips for picking the perfect API partner.

As the industry utilizes more sophisticated protein structures in complex biologics development, how do we optimize the affinity chromatography step to ensure higher yields for more efficient biomanufacturing at scale?

Navigating your oral solids project can be a challenging path. In this first installment, we look at the importance of technical groundwork and understanding excipients in the early stages of your project.

Aseptic filling has changed. High-speed machines designed for a single format are no longer suitable. Learn how aseptic filling work cells provide flexibility at the core of a standardized system.

Learn more about inclusions for your total cost of ownership, calculations to consider for cGMP chemical supply chain TCO, and how one midsize CDMO improved cGMP chemical supply by outsourcing.

Topical products, whether prescription dermatological drugs or over-the-counter lotions, creams, or gels, present unique challenges in terms of development and manufacturing.

A pharmaceutical company sought a development and manufacturing partner to assist with an in-licensed product originating from an emerging pharma company, a molecule in clinical Phase 2/3 trials.

Combining a rapid launch following regulatory approval with effective messaging and post-launch services can provide a competitive advantage.

Gain insights into a “simul-spray” process pioneer for combining small and large molecules into a single atomized drug product for inhalation administration.

Explore how to assess the risks of properly developing therapeutic drug candidates, including employing computer modeling tools, novel cell-based assays, and a full economic viability appraisal.

Explore the three phases of sterile injectable project tech transfer, including how to bridge information gaps and facilitate successful regulatory filing at this fundamental stage of drug development.

Clinical supply innovators from across the industry share their experiences and lessons learned as they work to normalize the use of adherence measurement tools and smart medicine packages.

Watch this webinar to learn about emerging technologies and approaches for intensifying mAb purification and diversifying bispecific antibody, fragment, and ADC pipelines.

Dr. Stephen McQuaker explores case studies to demonstrate how drug substance and drug product development plans can be accelerated through innovative science and expertise to get drug substances off the critical path.