Biopharmaceutical Application Guide
Browse the Biopharmaceutical Application Guide to help you find the right MilliporeSigma solutions for your process needs, including pharma raw materials, equipment and systems, manufacturing single-use solutions, filters, sampling solutions, and services.
This guide reflects decades of industry and application expertise and is available for mAb, vaccines, microbial, ADC, and plasma processes.
Monoclonal Antibodies Process
MAb therapeutics have specific formulation and delivery requirements, including the ability to administer via injection, and formulation at a high protein concentration. MAb manufacturers must support the production of increasingly higher-yield cell cultures and new formulations, while ensuring process safety and reproducibility across multiple products.
Continued development of innovative mAbs requires:
Vaccines and Viral Therapy Process
Vaccines manufacturers are concerned with balancing speed to market and cost containment, while maintaining product safety. This implies many process challenges such as:
Human plasma is the source of hundreds of proteins including albumin, clotting factors, immunoglobulin, and fibrinogen.
Products. Services. Expertise.
The immunoglobulin, albumin and factor VIII markets represent nearly half, 15%, and 10% of the plasma-derived market, respectively. The albumin and immunoglobulin markets are projected to grow further with the introduction of new therapeutic applicati0ons and increasing demand in emerging countries. Factor VIII is used for the major bleeding disorder Haemophilia A. Despire the development of its recombinant version, more plasma-derived factor VIII will become available to patients in countries where patients have limited access to clotting factors.
This implies new process challenges, such as developing new formulations and achieving higher yield, while ensuring process safety and reproducibility of multiple products.
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.
Microbial Process. Insoluble Protein Expressed in E. coli
Human plasma is the source of hundreds of proteins including albumin, clotting factors, immunoglobulin, and fibrinogen. With more than 450 brand-name and biosimilar therapeutic products on the market, microbial-based biopharmaceuticals produced in E. coli and yeast represent nearly one third of biopharmaceutical drugs.
Among the different production platforms, E. coli
is projected to continue as the preferred platform as it is the safer expression mode, the most cost-effective production solution, and is well established with regulatory agencies. From a manufacturing perpective, producing biotherapeutic with E. coli
allows manufacturers to rapidly respond to strong market demand. Microbial production supportsrapid development of scalable harvest and clarification steps, while ensuring product quality and reproducibility.
Despire its popularity as an expression platform, microbial production does present a number of technical challenges during development and implementation at all scales.
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 Merck 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.