Outsourcing

Determination of sodium chloride level is critical for assessment of purity of yeast extracts. This case study demonstrates the validation of an ion chromatography method as a suitable analytical approach.

HPLC coupled with charged aerosol detection is a suitable analytical technique to quantitate and characterize polysorbate-80 in therapeutic products; allowing quality assessment of raw material, content confirmation during manufacturing, and monitoring product stability.

A monoplant may offer greater supply security and flexibility for specialist medicines.

Bio/pharma companies facing new challenges in light of the increasing HPAPI market may benefit from outsourcing.

Single-use systems can be a cost savings for CMOs, and these savings can be passed on to clients and, ultimately, to patients.

GHO Capital, a European specialist investor in healthcare, announced its acquisition of Sterling Pharma Solutions, which specializes in complex and difficult-to-manufacture APIs.

Recipharm has received ISO 45001 certification for its Wasserberg facility in Germany as a result of the facility’s program to enhance sustainability and safety.

Investigation of peak purity failure during HPLC method validation led to discovery of a co-eluting impurity under the main peak. Spectral analysis, including three-dimensional modelling, was used to characterize the peak, leading to the development of a new HPLC method for analysing impurity content.

The acquisition would strengthen Charles River’s contract research capabilities.

Catalent adds position of president and chief operating officer to lead sales and quality efforts.

In a partnership with Thermo Fisher Scientific Pharma Services, Pacira added a manufacturing suite in Swindon, UK, that doubles the company’s capacity by mirroring the company’s facility in San Diego, CA.

Nine award winners from the 2019 edition of Pharmapack Europe, covering innovations across drug delivery, packaging, and materials and components, have been announced by the event organizers.

PCI Pharma Services expanded capacity of its commercial packaging site in Illinois.

Radha Iyer, vice-president and head of Quality and Scientific Affairs, Global Developed Markets, Dr. Reddy’s Laboratories, discusses new initiatives at the company.

Keeping abreast of the latest industry trends and retaining flexibility are key to maintaining a strong market position.

Company launches new services dedicated to emerging biotech and biopharma companies.

Novel analytical methods may help biologics manufacturers respond to stricter regulations on particulate matter.

Tech transfer is key to succession advancing biopharmaceutical pipeline products from research to preclinical.

Outsourcing of analytical testing and processes can help bio/pharmaceutical companies expand their product profiles.

Pharmaceutical Technology spoke with John Pirro, senior director of large molecule bioanalysis at WuXi AppTec, which provides anti-drug antibody (ADA) and neutralizing antibody (Nab) assay development, validation, and sample analysis services, about best practices to ensure that biologics are safe and effective.

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.

Suppliers set the tone for 2019 with strategic expansions, investments, and acquisitions.

A look at some best practices to ensure that quality control is maintained in the client–vendor relationship.

Only careful planning can prevent problems that stem from differences between a sponsor’s and a CDMO’s equipment, practices, and culture. This article highlights best practices and case studies.

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

CDMO leader Marc Funk will succeed Ridinger as CEO of Lonza.

Fujifilm increases capacity of its Bio-CDMO business with an expansion of production in North Carolina.

The $252-million acquisition is expected to strengthen Cambrex’s position as a small-molecule CDMO across the drug lifecycle.

Requirements for virus filtration must be considered in developing continuous downstream processes.

Outsourcing of manufacturing activities is expected to increase in 2019.