Manufacturing, Lyophilization

PCI Pharma Services is investing $100 million in manufacturing capabilities and capacity expansion to its Bedford, NH facility.

The Luna Probe One-Step RT-qPCR Mix with UDG is designed to enable sensitive, linear, real-time detection of target RNA sequences.

The need for sustainability and early considerations of a lyophilization strategy grow more pertinent on the back of growing biologics volume.

Baxter will invest $100 million in new lyophilization equipment and an additional aseptic syringe filling line at its Halle/Westfalen (Germany) location.

SP Scientific Products’ SP Hull LyoStar 4.0 R&D freeze dryer supports rapid freeze-dry cycle development, optimization, and process scale-up.

Breakthroughs in analytics and alternatives to traditional freeze drying promise to reshape biological development and the cold chain.

The need for lyophilization services is growing as a burgeoning pipeline of new biologics matures.

Temperature-sensitive biologics are lyophilized to preserve therapeutic viability, but the process presents complexities and challenges that are as yet not fully understood.

Technical advances in process understanding and control must be accompanied by a change in mindset.

Most extractable and leachable (E&L) studies are based on liquid formulations. This article examines options for E&L studies to evaluate leaching from primary packaging into lyophilized drugs.

Non-destructive surface area measurement can improve stability testing.

Rentschler Fill Solutions and Ultragenyx announce fill and finish agreement for the US commercial supply of Mepsevii.

Researchers at Purdue University and and industry experts have partnered up at the Advanced Lyophilization Technology Hub to optimize the 70-year-old freeze-drying process.

A technology roadmap aims to drive and consolidate improvements in a process that has remained unchanged for more than 70 years.

GE Healthcare continues to ramp up its offerings in the bioprocessing space with the purchase of Asymptote and a continued partnership with Zenith Technologies.

The objective of this study was to assess the impact of manufacturing-scale, freeze-thaw conditions on aggregation and subvisible particle formation of a monoclonal antibody solution (mAb-A; IgG1) using a small-scale model.

Excipient selection strongly influences lyophilization performance for biologic drugs.

An approach to stabilize PBS-based formulations could provide a simple physiological solution for use of proteins in research, preclinical, diagnostics, and clinical studies, as well as commercial biotherapeutic products.

This study offers a strategy for stabilization of biotherapeutics for long-term frozen storage in PBS-based formulations.

The company manufactures biological drug products and intermediates for the allergy vaccine market.

Headspace moisture analysis is a rapid non-destructive analytical method that may potentially address the limitations of traditional methods used for residual moisture determination.

Subjective visual evaluation of freeze-dried products can be quantified through mechanical methods of characterizing the properties these materials.

The authors explore the use of statistical experimental design and multivariate analysis to develop a drug substance formulation matrix.

This article reviews factors that affect protein stability at different steps of the product manufacturing process and strategies to minimize their impact on product quality.

Researchers are using current understanding of the lyophilization process to predict performance on many levels during both process development and manufacturing.

Vetter has ready-to-submit documentation for this service in Common Technical Document (CTD) formats for the US, Europe and Japan.

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

The authors present approaches used to reduce reconstitution time of a lyophilized high-concentration protein drug product.

Using an alternate moisture-generation method may provide more accurate data for regulatory submissions.

The authors describe a novel means to control ice nucleation using a sterile cryogenic ice fog.