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Looking for information on sterile manufacturing, parenterals, medication delivery, and more? If so, you will find helpful white papers on a variety of topics in this section.
Lyophilization is commonly employed for parenteral drugs that have poor stability in solution. In addition to formulation and process development, a robust container - closure (c/c) system is crucial for a successful lyophilized product.
There are cases where the long-term shelf life of a drug product solution is undesirable. This white paper describes two experimental methods of determining “choked flow”, namely the minimum controllable pressure method and choke point method.
The seasonal influenza vaccine market is projected to reach more than $4 Billion USD by the end of 2022. It is a safe assumption that as demand for seasonal influenza vaccines increases, so too with the demand for contract manufacturing organizations (CMOs) to support.
Mannitol is a versatile excipient used in freeze-dried injectables in the pharmaceutical industry due to its high eutectic melting point when it is crystallized. This allows for aggressive primary drying thereby considerably reducing the freeze-dry cycle time.
Convenience, product differentiation, and less waste are great reasons to develop a product in a prefilled syringe. Learn the options available for prefilled syringes and some considerations for developing and manufacturing the product.
With the advent of more product niches and often lowered production quantities, facilities that are experienced and versatile in handling cytotoxic, highly potent, and non-cytotoxic oncology products can present a valid option when considering outsourcing.
Formulation and process development for injectable products are typically conducted at laboratory-scale. There are few challenges when increasing the scale of production for a solution formulation, but the challenges drastically increase when the formulation is intended for lyophilization.
Identifying the failure points for a product enables the development scientist to design a formulation and process with meaningful ranges supported by data.
The ultimate goal of formulation development is a stable product. A well-designed product development plan can develop a phase 1 product quickly, while laying the foundation for commercial product success.
Provides an overview of:
A study was performed to use a more scientific approach to establish leak rate acceptance criteria
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