Manufacturing, Biologics

Ajinomoto Althea opens manufacturing suites in new high potency and antibody drug conjugate commercial facility.

Traditional planar culture formats are being superceded by microcarriers for large-scale cell therapy manufacturing.

A case study demonstrates that affinity chromatography can offer efficiency and scalability for gene therapy manufacturing using viral vectors.

Consider automation early in the rollout of clinical translation and scale up of clinical-trial protocols.

The development of emerging therapies poses unique manufacturing and formulation challenges for drug developers as candidates like cell and gene therapies advance through the pipeline.

Focused around Purdue University’s LyoHUB, a new blueprint aims to bring innovation to equipment and processes. One goal? Continuous freeze drying.

The agency is looking for industry input on best practices for continuous manufacturing.

Catalent and US WorldMeds have entered into an agreement for the commercial manufacture of lofexidine, a drug used to alleviate opioid withdrawal symptoms.

Modeling tools help process engineers optimize a biopharmaceutical facility’s capacity.

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

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.

AstraZeneca and Champions will develop new cohorts of patient-derived xenograft models to be used in oncology programs in breast and lung cancer as well as for use in other academic and industry applications.

The first program of this collaboration will focus on the development of a candidate for severe acute pancreatitis.

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.

Lonza further expands its micronization services with the acquisition of Swiss contract manufacturer, Micro-Macinazione, following its previous $5.5-billion acquisition of dosage form provider, Capsugel.

The Washington-headquartered biotech firm plans to use the newly purchased facility to produce antibodies for its current and future pipeline.

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

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

Media manufacturers are focused on reducing risk, improving quality and consistency, and managing costs.

Industry experts weigh in on best practices, challenges, and mutual recognition of cleaning validation standards.

Managing and prioritizing risk is essential to ensuring raw material quality. USP is developing new guidelines to make the work easier.

Lonza introduces new modular complex that offers flexibility and individually tailored solutions to biomanufacturing challenges.

Recipharm set up a manufacturing line at its facility in Sweden using LIDD’s NanoZolid technology.

Manufacturing capacity will be increased by one third and approximately 300 new high-wage and highly-skilled jobs will be created at the Fremont site.