Contract Analytical Services

Pharmaceutical Technology spoke with Lisa Crandall, MS, associate director CMC Project Management, and Peter Angus, PhD, director of Pharmaceutical Sciences, at Velesco Pharma, which provides a full range of stability testing of API and drug products, about best practices in stability testing.

SGS announces expansion of cell bank and bulk harvest testing services.

The company will invest $4 million to increase topical and transdermal formulation development and performance testing services at its Durham, NC, facility.

With the $252-million acquisition of contract development, manufacturing, and testing organization Avista Pharma Solutions, Cambrex will enter the market for early stage small-molecule development and testing services.

If a vortex mixer produces too much energy during sample preparation for particle size analysis, the size and morphology of particles can change. A study compares the applied shear to sample suspensions of ibuprofen to observe the effects of applied shear on the particle size distribution.

The investment in the company’s Mississauga, Canada, laboratory includes an expansion of existing cell/tissue culture capabilities, flow cytometry, mass spectrometry facilities, and more.

The contract development and manufacturing organization expanded its analytical chemistry suite and added a new office in Boston, MA.

The pharmaceutical, clinical, and bioanalytical contract solutions provider has implemented advanced techniques for the collection and use of peripheral blood mononuclear cells (PBMCs) for early-phase clinical trials at its Clinical Pharmacology Unit in Antwerp, Belgium.

An expansion of laboratory facilities in Geneva, Switzerland expands SGS services for high-order structure analysis.

The API and drug product provider will invest £375,000 (US$493,000) in additional nuclear magnetic resonance (NMR) instrumentation at its headquarters in Craigavon, UK.

The company expanded its extended workbench laboratory services program to support the ongoing manufacturing and development of Flexion Therapeutics’s Zilretta (triamcinolone acetonide extended-release injectable suspension).

Innomech has developed an innovative new test station for Fluidic Analytics to streamline R&D programs. The new test station serves as a labor-saving R&D tool to help process multiple test samples and to ensure product quality.

The contract service provider will invest in a laboratory expansion at its site located in Tredegar, Wales, UK.

Access to multiple analytical techniques is essential for fully characterizing complex protein formulations.

The contract research organization has added a new analytical laboratory in Middleton, WI, to expand its biologics testing capacity.

The new 73,000-square-foot facility is one of several expansions to support the company’s biologics testing capabilities.

The company aims to add the additional analytical services in the European Union throughout 2018.

A $800-million acquisition of MPI Research expands Charles River's offerings for early-stage contract research.

Successful outsourcing relationships in early phase drug-development analytics are driven by partnership.

KBI Biopharma's acquisition of Elion Labs expands KBI's biophysical and analytical characterization capabilities.

The acquisition strengthens Charles River Laboratories’ capabilities in the oncology and immunology therapeutic areas.

QuintilesIMS has changed its name to IQVIA to reflect its October 2016 merger with IMS Health.

Almac Group will acquire BioClin Laboratories to expand Almac’s analytical service offerings.

The collaboration will focus on developing a novel and differentiated challenge model for respiratory syncytial virus.

The acquisition broadens the CDMO’s preclinical and clinical offering to include bioanalytical and drug discovery services.

Forced degradation studies can identify stability problems for drug substance and drug products.

Alcami will move its headquarters to Durham, NC while maintaining its manufacturing and laboratory operations in Wilmington, NC.

Respondents cited instrument maintenance and downtime, complexity of testing requirements, and time-consuming sample preparation as the top challenges in their laboratories.

Sartorius Stedim Biotech combined the company’s ambr 15 bioreactor system with the Nova BioProfile FLEX2 cell culture analyzer for laboratory experiments.

USP describes analytical and microbiology testing required for different types of pharmaceutical water.