Manufacturing

Takeda will invest more than 100 million Euros to build a new manufacturing plant for its dengue vaccine candidate in Singen, Germany.

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

Patheon adds API manufacturing capacity with acquisition of Roche’s Florence, SC facility.

Wockhardt Limited received a warning letter from FDA for CGMP violations.

Oxford Genetics has been awarded a grant to develop packaging cell lines for virus bioproduction and will work in collaboration with the University of Oxford to generate cell lines for the scalable manufacture of retrovirus and lentivirus vectors.

Saneca Pharma has secured an agreement with Italian pharmaceutical company Menarini Group to deliver controlled-release pellets for one of its products.

Avecia is adding drug substance capacity at its Milford, MA manufacturing site.

New software platforms aim to help manufacturers implement connected technology and use data efficiently.

The half-cycle method for validating sterilization can have adverse effects on materials if used for steam sterilization.

PDA’s first aging facilities survey suggests that post-approval changes play a major part in slowing pharmaceutical industry investment in new technology.

The agency recommended nine drugs including treatments for diabetes, hepatitis B, and HIV.

The new Boston laboratory offers advanced analytical testing services.

GS1 US published new guidelines in preparation for the serialization and traceability requirements associated with DSCSA.

PMMI, The Association for Packaging and Processing Technologies, released a report on trends opportunities in packaging of pharmaceuticals and medical devices that predicts increased spending on capital equipment for processing and packaging.

Honeywell has launched a new range of gloves, Picguard Urban, which offers protection against needle stick and puncture.

UPS entered into a definitive purchase agreement to acquire Marken, a provider of supply-chain solutions for the life-science industry.

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

German biotech ARTES and Iranian biopharma manufacturer BioSun will develop an HPV vaccine.

This article will clarify reasonable expectations for the responsibilities of topical product formulation developers and for excipient suppliers regarding the information and samples for experiments needed for QbD.

A lifecycle approach can be used to develop GMP-compliant cleaning procedures for continuous manufacturing of solid-dosage pharmaceuticals.

Shear-sensitive ingredients in a tableting formulation experience different conditions in a batch tumble blender than they would in a continuous paddle blender.

Vendor selection and materials testing are complex enough, but in today’s volatile environment, risk mapping and monitoring are also crucial.

Outcry against high pharmaceutical pricing brings questions of high R&D costs and restrictive payers, but also drug development and manufacturing efficiency.

Covert and layered approaches to combat drug counterfeiting and illegal diversion strive to stay ahead of criminal enterprises.

Governments stretch limited resources to track counterfeit, diverted, and stolen pharmaceuticals globally. \

Recipharm is investing more than EUR1.2 million to enhance its small-scale GMP API development and manufacturing capabilities in Paderno Dugnano, Italy.

Astellas will acquire Ganymed and its portfolio of ideal monoclonal antibody candidates.

The biosimilar pathway permits licensure based on less than full clinical data.

The proliferation of counterfeit medicines is nothing new to pharma; however, the scale of the problem seems to be escalating.

TraceLink launched the EU-hosted early access program to reduce the time, cost, and risk of achieving regulatory compliance for global requirements.