Formulation Development

FORMULATION DEVELOPMENT WHITE PAPERS & ARTICLES

  • Telltale Signs You’re With The Wrong CDMO

    Is your CDMO an asset or a hindrance? This article explores 10 red flags that signal your parter isn't carrying its weight on your journey to commercialization.

  • How To Pick The Right CDMO For Late-Phase Clinical Trials

    For pharmaceutical companies without their own facilities, choosing the right partner for late-phase clinical trials and commercial production is a critical consideration in developing parenteral products. This article examines some of the key criteria for selecting the right CDMO partner and includes a case study that shares some challenges involved in a late-phase technology transfer for a parenteral product.

  • What You Need To Know About Process Characterization And Validation For Biologic Processes

    Process characterization and validation can be challenging, but using a risk-based approach to generate an appropriate control strategy will help assure your product meets these requirements, enabling timely approval and launch to market.

  • The Path To High-Quality Immunoassay Reagents

    There is a continued demand for novel, fit-for-purpose immunoassays. Despite the challenges, it’s important for assay developers to streamline the selection and potential modification of critical reagents to get their tests to market quicker.

  • Enhanced Host Cell Protein Analysis In Biologics Manufacturing

    iEnzyme-Linked Immunosorbent Assays (ELISAs) to monitor host cell protein levels are challenging. This article illustrates an enhanced anti-host cell protein antibody coverage analysis method solution.

FORMULATION DEVELOPMENT APPLICATIONS & STUDIES

FORMULATION DEVELOPMENT PRODUCTS & SERVICES

The Hitachi Koki model himac CR22N High-Speed Refrigerated Centrifuge offers reliable performance with a maximum RCF of 55,200xg and capacity of 6L for bottles, tubes, or microplates. Patented features such as the Automatic Rotor Identification and Rotor Cover Detector make the CR22N the ideal separation tool for multiple research applications involving DNA, RNA, viruses, proteins, and more.

The CP100WX is a general-purpose Ultracentrifuge with outstanding performance up to 100,000 rpm assisting in a wide range of separation protocols in involving proteins, DNA, RNA, metal nano-colloids, and more. Reliable and efficient the Hitachi CP100WX features a Rotor Life Management (RLM) system to automatically maintain rotor logging history maximizing rotor life.

NuAire benchtop centrifuges offer mono and multi functionality, refrigerated and non-refrigerated models. Technical innovations optimize productivity in your laboratory work to improve results, save time, while providing a greater relative centrifugal force (RFC).

The Jet Feeder is a multi purpose system for feeding powders into liquid and for low shear mixing. It is the perfect unit to use on those products that are sensitive to shear. ILC Dover completed a successful test at a pharmaceutical facility for mixing starch into solution for a tableting process. The system is cGMP, easy to clean or CIP, and will work in single pass processes or recirculating processes. JetSolutions is an ILC Dover company and is the manufacturer of the Jet Feeder.

NuAire offers ventilated and refrigerated micro-centrifuges ideal for high and low speed applications for small sample volumes.

Nanoparticle size analyzer with zeta potential measurements.

The new Zetasizer Ultra is our most advanced system for the measurement of particle and molecular size, particle charge and particle concentration, and represents the most intelligent and flexible instrument in the Zetasizer range.

Nanoparticle size analyzer with zeta potential measurements.

The Zetasizer Pro is a robust and versatile system for the measurement of particle and molecular size and electrophoretic mobility and zeta potential of nanoparticles.

NuAire benchtop centrifuges offer mono and multi functionality, refrigerated and non-refrigerated models. Technical innovations optimize productivity in your laboratory work to improve results, save time, while providing a greater relative centrifugal force (RFC).