Manufacturing

Ajinomoto Althea’s Optima VFVM 7000 aseptic fill/finish line supports a range of drug substance APIs.

Roquette, a biopharmaceutical company specializing in plant-based excipients, announced the opening of a new R&D and customer technical service facility in Singapore in fall 2017.

With £4.5 million (US$5.8 million) in funding, the consortium is tasked with developing a new automated continuous biologics purification unit to make biologic drug manufacturing more efficient.

CDMO Micro-Sphere is investing CHF 21 million (approximately $21.63 million) into the expansion of its GMP manufacturing capabilities at its Swiss facility.

The agency published guidance on identifying trading partners under DSCSA.

The company is voluntarily recalling Lorazepam Oral Concentrate, USP 2mg/mL because of misprinted dosing droppers.

Regenerative thermal oxidation (RTO) has become a common solution to treat volatile organic compounds (VOC) and hazardous air pollutants (HAP) present in the emissions of many pharma production processes. Regenerative thermal oxidation devices used to treat halocarbons should be designed to prevent corrosion. Anguil Environmental Systems explains best practices for addressing potential fail points in the materials of construction when designing process emission handling systems.

Everyone from IT departments through to manufacturing line personnel should be aware of cybersecurity threats and how to prevent attacks.

Pilot tests will evaluate a system developed by Ambrosus Technologies, using smart contracts and advanced sensors to ensure pharmaceutical quality, safety, and traceability.

On August 10, 2017, FDA announced a voluntary recall of all liquid products manufactured by PharmaTech and distributed by Leader Brand, Major Pharmaceuticals and Rugby Laboratories because of possible Burkholderia cepacia (B. cepacia) contamination.

Artificial intelligence offers a number of opportunities in pharmaceutical drug development and manufacturing, but there are barriers to overcome, notably around how well and how quickly the regulatory environment can adapt and keep pace with to the rapid changes.

Efforts to establish an international system for identifying and tracing drugs through the global supply chain are moving forward.

Cambrex is investing $24 Million in new, highly potent API manufacturing capacity at its Charles City, Iowa site.

The acquisition adds sterile manufacturing capability to the CDMO’s services, which include API formulation and manufacturing.

Pfizer will invest $100 million to expand its manufacturing facilities in Sanford, North Carolina.

Following passage by the House in July 2017, the Senate has voted to pass a reauthorization bill for FDA user-fee programs for drugs and medical devices ahead of the user-fee programs’ expiration date.

Sterigenics has increased gamma sterilization capacity in Fort Worth, Texas.

CordenPharma is investing €10 Million in a new line at its Plankstadt, Germany site.

The International Society for Pharmaceutical Engineering (ISPE) introduced its Biopharmaceutical Manufacturing Conference, happening December 4–6, 2017 in San Francisco, California.

Characterization of the product and process is key for process development and scale-up of topical drug manufacturing using a QbD approach.

Watson-Marlow Fluid Technology Group (WMFTG) has expanded its range of peristaltic cased pumps for upstream and downstream bioprocessing tasks.

The VENTILUS LE series for production-scale applications from Romaco offers three versions: LE-D for drying processes; LE-G for granulating fine solid particles; and the LE-C for coating them.

Sartorius Stedim Biotech has expanded its range of single-use membrane chromatography solutions with Sartobind Cassettes, a pod-like modular system for commercial applications in both capture and polishing.

Amid contentious debate about “fake news,” peer-review papers offer vital, objective insight.

Systems that discourage continuous improvement threaten pharma innovation, quality, and supply. Can the industry break through this deadlock?

Lawrence Yu, Deputy Director, Office of Pharmaceutical Quality at FDA’s Center for Drug Evaluation and Research (CDER), shares insights with Pharmaceutical Technology.

Statistical methods and novel indices can be used to monitor and benchmark variability, and guide continuous improvement programs in late-stage drug development.

Horizon to make publicly available its complete annotated CHO cell-line sequence in hopes of driving bioproduction cell-line innovation.

Cryopak’s CryoCube reusable temperature-controlled shipping systems are available in several insulation categories, and a tailored solution can be modeled using thermal modeling software.

FDA advances the progress of biosimilars with acceptance of regulatory filing for biosimilar referencing a blockbuster biologic by Roche.