Pharmaceutical Technology Editors

FDA noted multiple manufacturing, testing, and labeling violations at American Family Pharmacy’s Indianapolis facility.

Pharma Integrates 2015 will be held on Tuesday 17th and Wednesday 18th November 2015 at the Grange City Hotel, London.

The European AIDS Vaccine Initiative has brought together leading HIV researchers from public organizations and biotech companies to develop protective and therapeutic HIV vaccines.

The new Syrina 2.25 is a compact auto-injector that uses the standard 2.25 mL prefilled syringe, based on Bespak’s proprietary VapourSoft technology.

GEA has entered into a collaboration with GSK to further develop self-contained, POD-based mini-factories for the manufacture pharmaceutical oral solid dosage forms.

The IQ Consortium is an organization that brings together pharma and biotech companies and facilitates partnerships between members.

The Transform hydrate-able film from Lubrizol LifeSciences is compatible with a range of APIs.

Citing compliance issues, FDA extends deadline for product tracing information requirements for dispensers to March 1, 2016.

Ashland presented a science-based strategy to enhance pharmaceutical formulation quality and advance drug delivery at AAPS 2015.

CDMO Xcelience opens new facility in Tampa, FL, for formulation and analytical services.

FDA’s inactive ingredients database (IID) has been under development for several years, as a way to allow generic and name-brand pharmaceutical manufacturers to check on the safety and performance of specific inactive ingredients.

The system is suited to support quality-control activities in a busy laboratory.

Catalent Pharma Solutions announced plans to quadruple the cold-chain capacity at its existing clinical supply storage and distribution facility in Shanghai, China. The expansion comes in response to increasing demand from domestic and multinational pharmaceutical sponsors and contract research organizations (CROs).

The company is voluntarily recalling the epinephrine injection, USP because of potential inaccurate dosage delivery.

The agency issued a draft guidance document on the requirements for submission of applications for liposome drug products.

ProBioGen plans to develop and scale-up production of a biosimilar to the mAb cancer drug trastuzumab and will transfer the commercial manufacturing process to Indonesia’s government-owned Bio Farma.

USP responds to FDA's draft guidance on the naming of biological products.

Croda Chocques SAS' excipient facility in France has received EXCiPACT certification from SGS ICS, making it the 24th manufacturing site to be certified to the scheme, which verifies that manufacturing of pharmaceutical-grade excipients meets current good manufacturing practices (cGMPs).  It is the third Croda site in Europe to receive this certification in the past year. Certification reflects a rigorous assessment program, both for the auditor and the audited, and the auditor's report had to be verified by an independent certification board.

Capsugel has launched its enTRinsic drug-delivery technology platform. Using pharmaceutically approved enteric polymers, the technology offers full enteric protection without the need for functional coatings and enables targeted release of gastric acid- and heat-sensitive active ingredients in the upper gastrointestinal tract. The new technology platform expands Capsugel’s range of modified- and targeted-release solutions and biotherapeutic formulation offering, and can be used for oral delivery of drugs, including vaccines, proteins, and peptides.

The new committee will attempt to recruit regulatory professionals outside of existing ICH members to improve overall global pharmaceutical regulatory harmonization.

Rx-360 announced that Mark S. Paxton has been appointed as the new chief executive office of the international pharmaceutical supply chain consortium. This appointment follows the successful growth of Rx-360 since its foundation in 2009 in the aftermath of the adulterated heparin tragedy. Rx-360 has 300 volunteers from more than 100 institutions that are organized in 17 working groups with activities in the US, Europe, China, and India.

The PRIME program is a drug development scheme to enable accelerated assessment of medications for conditions with unmet need.

Dow introduces solvent-free productivity technology for coating barrier membranes.

Shimadzu and Hanson Research partner on pharmaceutical testing instrument integration.

Eight researchers are honored at the 2015 AAPS annual meeting for contributions to the pharmaceutical sciences.

Association recognizes top scientists and students at the annual meeting for research achievements.

EMD Millipore, the life-science division of Merck KGaA, has introduced Parteck SRP 80, a new functional excipient for oral sustained-release formulations. The excipient is polyvinyl alcohol (PVA)-based and fully synthetic-according to EMD Millipore, this feature ensures batch-to-batch and performance consistency and facilitates quality by design (QbD) and validation processes.

Bottles of the affected lot were marked with a lower strength of 325 mg instead of 500 mg and pose a risk of drug overdose that can lead to liver toxicity or liver failure.

An industry-led strategy was launched in September 2015, in which senior experts from life-sciences and chemical companies set out how Scotland provides the infrastructure, connectivity, and academic excellence necessary to sustain a thriving manufacturing base.

Univercells will integrate its single-use bioprocess with the Takeda vaccines production platform to allow local production.