Manufacturing

Innovative new technologies released over the past several months seek to enhance bio/pharmaceutical development and manufacturing. 

Implementing quality by design in product design and formulation and manufacturing workflows can help improve efficiency and shorten development times.

While cold-form, foil-foil (aluminumaluminum) blister packaging is considered the most moisture-protective packaging available, in fact, plastic containers such as bottles and tubes, when combined with desiccants, such as silica gel canisters and packets, will often provide lower internal relative humidity for long time periods.

Faced with unprecedented flooding from Hurricane Harvey and days of persistent rain, Arkema’s Crosby, TX, plant lost all power, causing flammable chemicals to ignite.

An FDA evaluation concluded that Corden Pharma Latina’s corrective actions addressed the concerns in an FDA warning letter.

The International Society of Automation (ISA) and Siemens entered a global partnership to increase awareness of industrial cybersecurity needs and standards.

Cambrex will expand its High Point, NC, facility with a $3.2-million, 11,000 ft.2 analytical laboratory.

FDA approves Novartis’ CAR-T therapy, marking the first time a cell therapy based on gene transfer has been approved in the United States for any indication.

FDA noted in a recent inspection that US Stem Cell Clinic was processing and administering stem cell treatments that were neither reviewed nor approved by the agency.

Steris added the Amsco 430LS and 630LS sterilizers to its line of medium steam sterilizers.

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.