Manufacturing

Conferences focused on continuous solid-dosage manufacturing aim to spread the word about technical capabilities and alleviate perceptions of regulatory uncertainty.

In a FDAVoice blog post, CBER Director Peter Marks discusses the new designation for cell therapies that treat life-threatening diseases.

Fisher BioServices will expand its CryoHub solution by co-locating it with the Cell and Gene Therapy Catapult manufacturing center for seamless supply chain management and to accelerate cell and gene therapy production.

Richard D. Braatz, PhD, will discuss using mathematical models to design a continuous drug manufacturing plant and the differences between batch and continuous operations for biologics.

Caladrius is selling the remaining percentage of the subsidiary in order to focus on cell therapy development.

The company announced that it would now be offering a portfolio of fresh and cryopreserved human and animal hepatocytes for ADME-Tox testing.

An influx of millennial workers may have an impact on whether pharma manufacturers choose to implement IIoT technology.

FDA sent a warning letter to Lumis Global Pharmaceuticals Co. Ltd. detailing CGMP deficiencies regarding API repackaging, labeling, and misbranding.

INTERPHEX 2017 exhibitors focus on shelf life, traceability, and quality control.

An enterprise quality management software system can minimize human error and help pharmaceutical manufacturers maintain standard operating procedures to prevent deviations from GMP resulting from not having or following written procedures.

Transparency between pharmaceutical companies and suppliers and risk assessment efforts are vital to effective supply chain practices.

Known as the Fast Series, the company’s new line of preconfigured track-and-trace products are designed to help pharmaceutical companies comply with serialization requirements fast.

Schreiner MediPharm’s multi-functional booklet-label combines several digital security features with an integrated first-opening seal.

QF20kSU single-use pumps from Quattroflow are used for applications requiring gentle product handling, high containment, low pulsation, purity, and cleanability.

Herma’s 152E Wraparound Bottle Labeler eases integration of print and vision systems.

Banner Engineering’s Sure Cross U-GAGE K50U Ultrasonic Sensor is used for wireless tank monitoring.

The patented SKAN NANOX Catalysts enable higher efficiency breakdown of hydrogen peroxide at lower temperatures for shorter decontamination cycles.

Parenteral packaging will be well-represented at INTERPHEX, especially technologies associated with fill/finish of ready-to-use vials, cartridges, and syringes.

The company made a €42 million investment in a new building at its Reinbek site to support the production of biopharmaceuticals.

The new ISPE Containment Manual is a summary of the process involved in the manufacture of highly active or highly hazardous pharmaceutical substances.

Moving to the next level of productive, reliable performance in bio/pharmaceutical manufacturing requires a willingness to make changes and create a quality culture.

The DME Facility Focus survey revealed best practices for coping with the challenges of aging facilities and implementing facility modernization.

The Mutual Recognition Agreement will allow FDA and EU inspectors to recognize each other’s work and avoid the duplication of drug inspections.

Industry experts discuss IIoT and its impact on pharmaceutical manufacturing.

Pharmaceutical Technology spoke with Frank Generotzky, plant manager for Baxter BioPharma Solutions’ Halle, Germany facility, about operational excellence at the site.

Capsule filling is a complex process, and the product to be encapsulated must be well developed to ensure mass uniformity.

Although best practices are key, advances in integrated informatics platforms and automation can make it easier to ensure data integrity and improve overall lab efficiency.

As the November 2017 deadline nears, a surprising number of companies still don’t have a serialization plan in place. New programs aim to get them compliant in time.

The UK Stem Cell Bank released validated stem-cell lines for researchers developing novel cell-based therapies for clinical trials.

The article reviews strategies for firms with or without existing in-house capacities and the pros and cons for outsourcing bio/pharmaceutical development and manufacturing.