With a rise in biosimilars, niche drugs, and therapeutic and molecular innovation, the biopharma market is seeing dramatic changes. As it continues to evolve, there are significant challenges we must overcome in order to deliver these therapies to patients.
How an agnostic and data-driven approach early on can optimize the development pathway to bring the molecule to the market faster.
How and why collaboration improves single-use products.
With many uncertainties when introducing a new drug to market, seeking manufacturing flexibility to accommodate diverse demands and production needs is key.
This case study shares the work of GE’s Fast Trak Services team to help accelerate development of a process for cGMP production of material for toxicology studies.
Discover how through automation, it is possible to achieve data acquisition, process monitoring and control, and batch record generation, allowing more complex unit operations to be run in cGMP environments.
Successfully sourcing commercial products for comparative studies often proves far more challenging than assumed. A comprehensive plan should include insight from comparator sourcing and clinical supply management, and effective collaboration between these critical functional areas is crucial.
Options for customizable single-use solutions that move as fast as the market does.
Examine common regulatory challenges and areas of uncertainty in the implementation of continuous bioprocessing, and understand practical, total solutions.
Addressing the concerns regarding limiting the rapid adoption and implementation of single-use technology has centered on standardizing single-use component extractables data packages to be used for end user risk assessments.
Single-use technologies are being seen as the solution to flexibly and cost-effectively address many of the challenges around creating biologics manufacturing capacity.
The plug-and-play nature of single-use enables you to incorporate new technologies and innovations into the process workflow as they become available. But beyond the flexibility of the single-use platform, you need to consider a range of other factors to ensure your capacity can will meet your long-term needs.
What technologies can help minimize viral contamination risks throughout the process.
This contract manufacturer overview highlights their expertise in complex organic synthesis, milling and micronizing, process optimization and scale-up, and more.
In biomanufacturing the only certainty is risk and the only constant is change. Technology is pushing new frontiers, new markets are opening up across the globe, and new competition is creating new levels of urgency—all under the ever more watchful eye of regulators.