Contract Manufacturing, Drug Substance, API

The deal expands Wavelength’s drug substance manufacturing footprint and its API CDMO business.

Cascade began production on new facilities to manufacture APIs for clinical and commercial GMP production.

The acquisition will integrate drug substance, drug product, and clinical testing capabilities under Quotient.

Piramal Pharma Solutions invests in expanded potent and non-potent API development and manufacturing at its Riverview, MI facility.

The expansion will be designed to meet the growing demand for small molecule drug substance development and manufacturing.

The lab, which is currently available to customers, can handle highly potent compounds.

Particle engineering is a useful tool to manipulate API particles into a form that is manufacturable and deliverable to the patient.

CordenPharma announces expansion of lipid excipients supply for coronavirus vaccine scale up.

Agreements with the PolyPeptide Group and AGC Biologics will scale up production of the Novavax Matrix-M adjuvant.

HHS announces $354 million in funding for private industry to manufacture generic drugs in the US from raw materials to finished product.

CMO Evonik begins capacity expansion of APIs and intermediates at its sites in Dossenheim and Hanau Germany to increase EU supply security for drug products.

FDA approved hydroxychloroquine sulfate for emergency use as a treatment for some hospitalized patients with COVID-19.

Wavelength Pharmaceuticals expanded production of APIs for certain pharmaceutical products needed to manage respiratory critical care patients in the COVID-19 pandemic.

Cambrex reports that the acquisition by the investment group will facilitate ongoing growth.

Sourcing hard-to-find ingredients and establishing a reliable supply chain can stretch the resources of a small- to mid-size pharma company.

An understanding-during early development-of the solid form landscape of an API can enhance product quality and manufacturing processes.

The latest research from GlobalData has revealed that more than two-thirds (69%) of CMOs high-containment facilities are based in the top five European Union countries and Switzerland.

The evolution of CDMOs has led to increased investment in new technologies, capabilities, and expertise.

To help customers succeed, CDMOs have moved away from the ‘fee-for-service’ model to offer flexible, full-service partnerships.

Complex and potent molecules demand greater technical and regulatory expertise to ensure safe handling.

Pharmaceutical Technology spoke with Anil Kane, executive director, global science and technology, pharmaceutical development services, at Thermo Fisher Scientific about the industry’s need for more capacity in the manufacture of highly potent APIs.

Does the pharmaceutical industry have adequate access to contained equipment, facilities, and infrastructure for the manufacture of highly potent APIs?

The company has expanded its high-potency API capability at its Riverview, MI, facility to serve the growing antibody drug conjugates market.

New CDMO facility supports early-stage API manufacturing and scale up.

Two additional production lines expand Lonza’s HPAPI capacity at Visp, Switzerland facility.

The acquisition of GlaxoSmithKline’s manufacturing site in Cork, Ireland, will expand Thermo Fisher Scientific’s global footprint for complex API manufacturing.

The investment will increase patient-centric dosage form manufacturing capabilities at Catalent’s Winchester, KY, facility.

Cambrex’s expanded quality control laboratory supports generic API development.

Supplier vetting and monitoring-plus comprehensive testing-ensure quality of raw materials.

A $100-million investment will expand a range of the CDMO’s service capabilities and offerings.