Contract Manufacturing, General

The new 30,000-L, $150-million biologics manufacturing facility in Wuxi, China, quintuples the company’s existing manufacturing capability.

The contract research, development, and manufacturing organization has expanded API aseptic manufacturing capacity at its Valladolid, Spain, facility.

Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.

Attracting and retaining qualified bio/pharma experts demands a mix of recognition, rewards, and opportunities.

For many processes involving hazardous chemistry, running in flow mode has safety and economic advantages.

Amid business and regulatory uncertainty, bio/pharma experts reveal opinions on salary, recognition, and training.

Lonza has entered into strategic license agreements for exclusive rights to a gene-therapy platform for developing treatments for hearing and balance disorders.

Biocad and Sothema Labs have partnered to release cancer-treating biosimilars into the North African market.

The acquisition gives GE Healthcare access to a nanofiber-based platform purification technology that can offer improvements in biopharmaceutical productivity.

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.

Avista Pharma Solutions facility and equipment upgrades at its Longmont, Colorado facility support processing of potent compounds.

Spectrum Chemical will provide BASF precious-metal-containing powder catalysts in research quantities for early product development.

A new facility type integrates next-generation mobile cleanroom systems.

The companies have established a joint laboratory to develop full continuous processing to manufacture high yields of monoclonal antibodies at reduced costs.

Alcami will manufacture clinical supply of the API for a drug candidate targeting various hematologics and solid cancers.

As part of Recipharm’s ongoing initiative to improve profitability and competitiveness, a decision has been made to end operations in Stockholm and Höganäs.

Almac Group will acquire BioClin Laboratories to expand Almac’s analytical service offerings.

Capsugel announced on Oct. 31, 2017 that it expanded clinical trial capabilities, as well as increased development and manufacturing capabilities for specialized drug products using liquid-filled hard capsule technology, at its Edinburgh facility in Scotland.

Recent acquisitions are creating CDMOs with scale that rivals global bio/pharma.

Industry experts were honored for business, scientific, and social contributions.

Catalent’s new Biologics & Specialty Drug Delivery unit will be led by Barry Littlejohn; Jonathan Arnold to lead Oral Drug Delivery.

The CDMO is investing £6 million into a new facility at its United Kingdom site to expand its milling, micronization, and solid form capabilities.

CordenPharma will expand development capacity for small molecules, peptides, and carbohydrates at its Liestal, Switzerland site

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

Samsung BioLogics’ second facility adds 152,000 L of mAb drug substance capacity.

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

Investments include the installation of development and analytical equipment to support the development of highly potent APIs as well as a new 2800-liter hydrogenator and 1500-mm diameter centrifuge for increased flexibility and capacity within the manufacturing plant.

CordenPharma will integrate the Hospira Boulder API manufacturing facility into the CordenPharma Colorado network for highly potent and oncology APIs.

Hitachi Chemical Advanced Therapeutics Solutions will expand its PCT service platform for cell therapy by adding GMP manufacturing and cleanroom capacity in Allendale, NJ.

CDMOs have established strategies for handling new chemical entities with unknown biological activity.