Contract Manufacturing, Drug Substance, API

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.

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

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

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

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.

Demand for highly potent APIs continues to rise.

Cambrex will create a new center of excellence for API process development and clinical supply at its High Point, NC facility and expand its API manufacturing facility in Italy.

Clovis Oncology and Lonza celebrated the grand opening of a dedicated production train at Lonza’s Visp, Switzerland site for manufacturing Rubraca (rucaparib).

At this year’s CPhI Worldwide congress in Madrid, Spain, Archer Daniels Midland Company (ADM) will present its range of products spanning probiotics and microbiome solutions to highly purified, injectable-grade vegetable oils.

Luxembourg-based pharmaceutical group, C2 Pharma (formerly known as Centroflora CMS) successfully validated the manufacturing process for two APIs-digoxin and digoxin micron.

The company will showcase the evolving role of vitamins and lipid APIs in pharmaceutical applications at CPhI Worldwide 2018.

Evonik completed a EUR 36 million expansion of its contract-manufacturing capabilities for API and advanced intermediates in the United States and Germany.

The $425-million acquisition adds formulation development and finished dosage manufacturing capabilities to Cambrex’s existing global API manufacturing network.

Existing software tools cannot take into account the complexity of disease.

Determining how much containment is needed for API handling requires evaluation of multiple factors.

This article provides a sampling of the latest investments, expansions, and acquisitions by small-molecule contract service providers.

Heightened uncertainty means CDMO executives need to play out planning scenarios.

A year’s worth of FDA warning letters suggest that API and finished drug manufacturers should strengthen their approach to continued process verification.

The glass and chemical provider will expand its synthetic pharmaceutical intermediate and API production capacity at its plant in Chiba, Japan.

The acquisition will place Cambrex into the finished dosage form CDMO market.

CELLforCURE will produce cancer CAR-T treatments for Novartis at a manufacturing facility in Les Ulis (Essonne), France.

Minakem’s facility in Belgium enhances capacity to scale production of highly potent ingredients for small to full GMP batches.

The contract development and manufacturing company has received an additional approval from Health Canada to manufacture monoclonal antibody drug substance at its first plant in Icheon, South Korea.

WuXi STA supported the development of hepatitis drug through marketing authorization holder pilot program.

Cambrex expands its generic API research and development capabilities at its Milan, Italy site.

Under the contract, AMRI will focus on the development and manufacture of APIs and drug product for Phase I clinical studies.

From separation systems to reactor technology, new tools are increasing the feasibility of continuous API production.

Cambrex invests $5 million in new laboratory expansion at its Karlskoga, Sweden facility.

GE Healthcare and the Centre for Commercialization of Regenerative Medicine (CCRM) will support scale-up efforts by DiscGenics for a new cell therapy intended to treat back pain.