Outsourcing

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.

While pharma is proving its capabilities to develop novel therapies, the industry still needs to work on manufacturing innovation.

Keeping valuable employees happy-and on the job-may test bio/pharma business decisions.

Intellectual challenge, work/life balance, compensation, and an unclear business outlook create uncertainty among European bio/pharma employees.

The company is investing approximately $14 million to expand biologics packaging capabilities and capacity at its biologics manufacturing facility in Bloomington, IN.

CMOs and CDMOs made investments in new and expanded facilities and services in the last quarter of 2018.

The contract research organization has increased its US-based early phase clinical capacity and doubled its specialty lab space.

Catalent will expand primary packaging capabilities and commission an automated, high-speed bottling line for clinical packaging of capsules and tablets.

ADC Biotechnology will invest downstream formulation, fill/finish capabilities, and Lock-Release conjugation technology.

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.

As biopharma companies rapidly change their focus, they may lack the laboratory space, instrumentation, and the scientific knowledge to support biologics research.