Contract Manufacturing, Finished Drug Product

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

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.

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.

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

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

Recipharm adds inhalation drug manufacturing capacity with the acquisition of Sanofi’s Holmes Chapel, UK site.

Rentschler Fill Solutions and Ultragenyx announce fill and finish agreement for the US commercial supply of Mepsevii.

Grand River Aseptic Manufacturing announces equipment purchase to add vial filling capacity.

Under an Innovate UK grant for a three-year project, Arcinova and the University of Nottingham will develop a continuous, flexible modular manufacturing technology platform.

Anthony Qu, PhD, vice president of Scientific Affairs at Halo Pharma, will give a presentation on fixed-dose combination products, drug products containing multiple active ingredients, as an effective approach for simplified dosing at CPhI North America on Wednesday, April 25, 2018 in Philadelphia, PA.

Hovione plans to continue to expand its sites in Portugal and Ireland for chemical synthesis, spray drying, and laboratory analysis.

In selling its contrast media business, Hovione will focus on API and drug product development and manufacturing.

Industry lessons from a fast-track technology transfer of a soft-gelatin capsule (softgel) are multifold. This case study reviews the success factors for effective execution of the technology transfer, which include: strong relationship between the customer, the contract development and manufacturing organization, and other partners based on deep knowledge in the technology; established and proven quality-by-design processes; risk mitigation management; project leadership; flawless execution; and mutual trust.

Hovione has installed a new MG2 Tekna Precision Capsule filler at its Portugal site.

The facilities in Brescia, Italy and Karlskoga and Uppsala, Sweden, are the latest of Recipharm’s sites to be equipped to supply serialized products to the United States.

Piramal is investing $55 million into the expansion of its API manufacturing capabilities and capacities across sites in North America and Asia.

Predicted areas of growth include flow chemistry, fermentation, repatriation of overseas funds, oncology, and API/product integration, but the rate of change is unclear.

CDMO Micro-Sphere is investing CHF 21 million (approximately $21.63 million) into the expansion of its GMP manufacturing capabilities at its Swiss facility.

CMOs must embrace flexibility in their technology decisions and business arrangements.

Pfizer’s new format of ibuprofen (AdvilR Liqui-GelsR Minis) uses Catalent’s softgel technology to deliver the formulation in a more concentrated fill, resulting in smaller capsules.

Recro Gainsville expands its tableting capacity with the addition of a tablet press and film coater.

The more pharma science and technology change, the more business and policy concerns stay the same.

Vetter expanded visual inspection facilities and controlled-temperature storage at its Ravensburg Vetter West facility in Germany.

Catalent announces a development agreement with JOT to evaluate softgel options for a resveratrol drug candidate.

Pharma Tech introduced a new high-speed bottling line to its facility in Union, MO.

The company has manufactured double-digit number of batches on the new filling line, for use in early-stage clinical trials.

Idifarma has acquired a Bosch GKF-702 capsule filling machine that can manufacture 3000 to 42,000 capsules per hour.

Catalent adds two softgel facilities and packaging capabilities with acquisition of Canada-based Accucaps.

The new facility will focus on formulation development, drug product analytical development, and quality control.

The strategies of a innovation-driven CMO may be different than a capacity-driven CMO.