Manufacturing, Lyophilization

Lyophilization Services of New England announces inspection approvals that will allow its Bedford, NH facility to begin manufacturing commercial drugs for US distribution.

Symbiosis Pharmaceutical Services is now offering a new bulk lyophilization (freeze drying) service in response to increasing demand in the manufacture of bulk intermediates and APIs by lyophilization.

This study evaluates the impact of controlled nucleation on the ability to optimize a lyophilization cycle for a monoclonal antibody formulation.

The VERISEQ nucleation technology offers a commercially viable technique for cryogenically generating a uniform dispersion of microscopic ice crystals (or ice-fog).

Efficient freeze-drying processes result in time and energy savings, reduced failure rates, and improved batch consistency.

While the optimization of a lyophilization cycle for a biologic relies on a well-characterized formulation, viscosity and aggregation after product reconstitution must also be carefully managed.

The effect of absorbed vapor-phase hydrogen peroxide on a lyophilized product Protein Z, was studied by spiking experiments with different amounts of hydrogen peroxide.

Common challenges and key considerations when developing a freeze-drying cycle for protein pharmaceuticals.

A new process analytical technology based on impedance spectroscopy has potential applications for characterizing product attributes during the freeze-drying process.

Recipharm has invested EUR 32 million ($43 million) in its Wasserburg, Germany site to expand lyophilization capacity.

A recent market analysis offers a promising outlook for contract fill-finish and lyophilization services.

CentuRecon enables dry formulations of therapeutic proteins to quickly be prepared for injection at high concentration.

Lyophilization technologies for controlled nucleation.

Optimized freeze-drying cycles can offer scientific and business advantages.

Even when all is well at the facility, one must expect the worst while braving the elements.

Experts share insights into analytical tools and techniques.

Experts share how to choose analytical tools and techniques when scaling up a lyophilization process.

Closed-vial technology is an alternative to traditional glass vial filling that reduces the risk of contamination for the patient, simplifies the filling process, and provides easier handling for healthcare providers.

Experts discuss the best practices for developing a QbD-based lyophilization process.

There are no two completely identical freeze dryer units in operation anywhere.

Lyophilisation is often necessary for pharmaceutical products to improve stability or shelf-life. However, the process can present difficulties, particularly when scaling up from the laboratory to commercial production. We bring experts together to discuss best practices for developing a lyophilisation process, including quality by design (QbD) and design space.

The author discusses the relative advantages and disadvantages of lyophilization in vials and dual-chamber systems.

We have changed the brand of our stoppers for a product that we freeze-dry in vials. Since the change, we have observed a significant increase in rejects for collapsed cakes. Why are the cakes collapsing? What can we do to prevent this problem?

In our manufacturing process, we are running into issues with our vial stoppers clumping in the feeder bowl. How can we ensure that the stoppers go through smoothly without clumping up?

The authors discuss the preparation of lipophilic drug nanocrystals by controlled crystallization during freeze-drying.

The article examines the drivers of customer perception of contract service providers of pharmaceutical development and manufacturing.

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the June 2011 edition from Meissner and Telstar.

A technical forum moderated by Patricia Van Arnum

This article examines the difficulties in designing lyophilisation processes that can be faithfully scaled up to production volumes and suggests the most effective ways in which this can be achieved.