Manufacturing, Biologics

Groninger will showcase its FlexPro 50 line for small batch production at CPhI Worldwide 2017, and present on up- and downstream processes with freeze-dryer developer and manufacturer Martin Christ.

Sartorius begins building a new, EUR 30-million (US$35.2 million) Cell Culture Technology Center in Ulm, Germany.

Detecting viral contaminants in biologic-based medicines-and identifying their source-requires a holistic testing approach.

Process analytical testing for biopharmaceuticals requires enhanced methods due to complex bioprocesses.

This study outlines methods for an alternative protein-polishing process for challenging proteins.

. This study is an attempt to produce a fusion protein by binding the fragment NT-gp96 in upstream of sequence of the N terminal fragment (NT300) of the NS5B gene in an expression vector.

ADC Bio announces plans to expand into clinical and commercial drug manufacturing for ADCs.

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Traditional planar culture formats are being superceded by microcarriers for large-scale cell therapy manufacturing.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