Application Guides

Browse our Biopharmaceutical Application Guide and Pharmaceutical Application Guide to help you find the right solutions for your process needs, including pharma raw materials, equipment and systems, manufacturing single-use solutions, filters, sampling solutions, and services.

Biopharmaceutical Application Guide

 

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.

 

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.

 

Plasma Process. Products. Services. Expertise.

Human plasma is the source of hundreds of proteins including albumin, clotting factors, immunoglobulin, and fibrinogen.

 

ADC Process

ADCs are challenging molecules requiring advanced manufacturing suites and dedicated equipment to characterize the molecule and demonstrate its purity, homogeneity and stability.

 

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.

Pharmaceutical Application Guide

 

Large Volume Parenterals

Large volume parenterals (LVP) are single-unit doses greater than 100 mL in volume. Typical solutions include water, dextrose (5–50%), amino acids, salts and viscous Total Parenteral Nutrition (TPN) components with batch sizes in the tens of thousands of liters.

 

 

Small Volume Parenterals

Small Volume Parenterals (SVP) include a wide variety of traditional and bioengineered drugs, and are typically packaged as small vials (< 100 mL), pre-filled syringes, ampules or lyophilized powders. Many SVP’s require aseptic processing after compounding or at the filling head.

 

 

Ophthalmics

Ophthalmics is a dynamic market driven by an aging population and continuous improvements in patient comfort. Typical industry focus is the design of new formulations with optimized drug penetration and patient comfort.

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.