Biopharmaceutical Application Guide
The Biopharmaceutical Application Guide reflects decades of industry and application expertise and is available for mAb & Recombinant, Gene Therapies, ADC and mRNA processes.Browse this guide to help you find the right solutions for your process needs, as we offer a convergent end-to-end portfolio of advanced, closed processing-ready technologies with extensive documentation for upstream and downstream operations, process analytical technologies (PAT), data analytics, automation, control software advance unit, non-GMP environment labs and CTDMO services.
Monoclonal Antibodies Process
mAb therapeutics are manufactured using a templated approach which requires robust, scalable solutions for all steps in the process from cell line development to final fill. Advancements in mAb manufacturing -including increased cell culture titer and density, high therapeutic concentration at formulation, and interest in continuous processing- require a trusted partner in the development process. Explore our technologies, products and services from Process Development to Commercial scale.
ADC Process
ADCs are challenging molecules requiring advanced manufacturing suites and dedicated equipment to characterize the molecule and demonstrate its purity, homogeneity and stability.ADCs also require an extended containment strategy to protect operators while avoiding the bulk product and the environment from any contamination.
We offer a comprehensive portfolio of products and services from Cell Culture Media to TFF, from buffers to stabilizers, as well as biodevelopment, bioconjuction, and contract manufacturing services of linkers and payloads to meet your ADC needs.
mRNA Process
mRNA technologies show strong potential to continue to unlock RNA medicines as a broader set of vaccines and therapies with significant advantages in terms of time-to-market, efficacy, and flexibility. However, these advantages come with challenges such as stability during manufacturing and storage, targeted and robust delivery, cost, safety, and tolerability profiles.We provide solutions to help you overcome your mRNA research, development, manufacturing and LNP formulation challenges. With our broad portfolio of best-in-class products, technical expertise, regulatory know-how, our CDMO capabilities and a wide range of services, we can support all stages of your mRNA drug manufacturing process.
Gene Therapy Process
Viral gene therapies offer immense potential to treat and cure countless diseases. However, for manufacturers of this new class of innovative drugs, the absence of a robust, scalable processing template can delay speed to market and delivery of these critical therapeutics to patients.To maximize productivity, purity, and yield, manufacturers need cost-effective technologies that provide consistent performance and enable easy scale-up and improved processing efficiency while minimizing risk. Explore our products, PAT, software & automation solutions, systems and services that can simplify your viral vector purification from process development to commercial scale manufacturing.
No guide will replace the need to conduct process development and optimization experiments. The unique nature of every process stream combined with application and regulatory requirements play a part in determining the optimum process solutions. Use this selection guide as a starting point for selecting and sizing the most appropriate MilliporeSigma solutions.
We provide information and advice to our customers on application technologies and regulatory matters to the best of our knowledge and ability, but without obligation or liability. Existing laws and regulations are to be observed in all cases by our customers. This also applies in respect to any rights of third parties. Our information and advice do not relieve our customers of their own responsibility for checking the suitability of our products for the envisaged purpose.
The holder of the manufacturing authorization shall ensure that the excipients are suitable for use in medicinal products by ascertaining the appropriate good manufacturing practice. This is particularly true if the material in a certain application is regarded as high risk excipient, for example in parenteral dosage forms.