Manufacturing

Improvements to aseptic manufacturing procedures are long overdue. But how feasible is it for manufacturers to modernize fill lines of legacy products?

InstantGMP PRO 3.0 software integrates production scales with an electronic batch record system.

Schreiner MediPharm’s Flexi-Cap Plus incorporates a label-integrated tear strip for enhanced security.

A new version of Siemen’s Simatic EBR software offers web-based master batch records and integration with automation systems.

Dalton Pharma Services completed an expansion in sterile filling and API manufacturing at its cGMP facility in Toronto, Canada.

The company is voluntarily recalling one lot of product due to a potential packaging mistake.

Recipharm is investing EUR3.7 million (approximately $4.18 million) to increase lyophilization capacity at its Masate facility in Italy.

The company is opening two offices in the United States that will offer serialization, automation, and process control services.

Fresenius Kabi will add to its generic, sterile injectable manufacturing at its Melrose Park, Illinois site.

Arbor Pharmaceuticals is voluntarily recalling Cetylev (acetylcysteine) effervescent tablets due to inadequate seal of the blister pack.

TOPAS Advanced Polymers announces its COC materials are compliant with new USP standard for pharma plastic packaging systems.

The Group is focusing on standardizing data exchanges between the enterprise serialization management function and product packaging lines.

Piramal Enterprises has entered into an agreement to acquire 100% stake in Ash Stevens all by cash for a consideration of $42.95 million plus an earn-out consideration capped at $10 million.

Irvine Scientific’s new product range includes chemically-defined, serum-free media, to increase productivity of viral vectors and recombinant proteins in suspension cultures.

The agency has adopted guidelines on the pharmacovigilance of biological drugs.

The GMP-certified facility will produce TruTag microtags for global pharmaceutical customers.

Herma’s wrap-around, high-speed labelling machine will be available for demonstration at its new facility in New Jersey.

The Claristep filtration system from Sartorius improves preparation of samples for analytical testing.

Jacobs Engineering Group was awarded a contract to provide engineering services and procurement for Alnylam Pharmaceuticals’ new manufacturing facility in Norton, Massachusetts.

The design of Baxter BioPharma Solutions’ aseptic filling lines provides a case study in customizing containment systems for multi-product lines

Three-dimensional printing allows unique benefits to be built in to solid-dosage forms.

Susan Schniepp, Distinguished Fellow at Regulatory Compliance Associates, discusses the regulatory requirements for improving manufacturing lines.

CMOs are working hard to improve performance by investigating new technologies for filtration and purification.

Regulators and manufacturers address economic and ethical issues for scarce medicines.

New technology introduced in 2016 aids innovation growth for pharmaceutical manufacturing.