Contract Manufacturing, General

The expansion includes a new R&D laboratory and the installation of a 12,000-liter reactor at one of the company’s manufacturing facilities on its Paullo site in Milan, Italy.

The acquisition of the site in Copenhagen, Denmark, will significantly expand Fujifilm’s capacity and capabilities.

Process optimization improves process mass intensity, reduces environmental impact, and improves cycle time for bio/pharmaceutical processes.

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.

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.

The “hands-on” seminar will be held June 12–13, 2019 and will feature educational sessions and demonstrations in the company’s process laboratory.

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.

The acquisition will boost Hitachi Chemical’s presence in the European regenerative medicines market.

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.

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

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.

Full commercial launch of the drug is underway in the United States, with Europe to follow.

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

The company is set to expand biologics and fill/finish capacity at its biologics manufacturing sites in Madison, WI, and Bloomington, IN.

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.

The Massachusetts site, formerly associated with an affiliate of Shire, is Rentschler Biopharma’s first facility in the US.

The company has brought a second stream of high-throughput GMP peptide manufacturing online.

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

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

Contract development and manufacturing organization (CDMO), Yposkesi, has entered into an agreement in principle with Axovant Sciences.

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.

In preparation for the upcoming US Drug Supply Chain Security Act deadline, Metrics Contract Services has expanded serialization capabilities at its oral solid-dose commercial manufacturing site in Greenville, NC.

Experts believe that the contract development and manufacturing organization market will reach $17.38 billion by 2022, with disruptive business models using Industrial Internet of Things (IIot) and single-use technologies proving more profitable and efficient in the long term.