Manufacturing

GenPak Solutions is cited by FDA for cGMP violations at its Hilliard, Ohio facility.

The collaboration will focus on the investigational candidate JTX-2011 and up to four other early-stage programs in immune-oncology.

The antisense drug will be the first in the companies’ joint development deal for medications to treat autoimmune disorders of the gastrointestinal tract.

FDA issued a warning letter to the Worthing, UK facility for cross contamination and microbial contamination cGMP violations.

A new study examines the oral delivery of protein drugs in plant cells and hypothesizes that the cold storage and transportation of biologics could someday be eliminated.

GE further ramps up its cellular and gene therapy offerings with its acquisition of Biosafe, a cell processing solutions company.

The company will collaborate with the Walter Reed Army Institute of Research to co-develop a Zika vaccine candidate.

The company will invest €100 million in the expansion of its Athlone facility.

Novo Nordisk broke ground on an expanded production plant for insulin in Kalundborg, Denmark.

A study shows high levels of ADAs to infliximab at the beginning of treatment were associated with a poor response later on.

The acquisition will give Bristol-Myers Squibb full rights to Cormorant’s HuMax-IL8 antibody program.

Revised versions of ISO 14644 Parts 1 and 2 introduce changes to sampling procedures and monitoring plans for cleanrooms and clean zones.

The authors present an overview of the types of RNA-based therapeutics in existence and their optimal methods of manufacture, purification, formulation, and delivery.

Recent trends in raw materials packaging may impact manufacturing, quality, and cost of biopharmaceuticals.

Capacity for complex therapeutics is become increasingly difficult to predict.

A streamlined approach may enhance process efficiency and product quality.

Pressures to accelerate current and next-gen therapies are challenging traditional microbiological testing methods.

CPhI Pharma Awards seek nominations for excellence in biopharma development and manufacturing.

Two recently published studies suggest that pre-exposure to the dengue virus (DENV) could predict a person’s reaction to the Zika virus (ZIKV) because of of the antigenic similarity between the viruses. One study was published on June 23, 2016 in Nature Immunology and the other on June 27, 2016 in Proceedings of the National Academy of Sciences of the United States of America (PNAS). Dengue and Zika are both mosquito-borne flaviviruses that are cross-reactive.

MilliporeSigma and the International Vaccine Institute in Seoul, South Korea aim to develop more robust, scalable vaccine manufacturing processes.

Studying broadly neutralizing antibodies in infants may lead to new pathways in HIV vaccine development.

The agency cited the company for sterile manufacturing violations.

A research team associated with Dr. Carl June announces it has discovered a way to engineer a patient’s own immune cells to recognize cancer-specific glycoantigens on tumor cells.

The first-ever use of CRISPR in humans will be evaluated by the National Institutes of Health during a meeting from June 21–22, 2016.

A new indication for Emergent BioSolutions’ BioThrax will give the drug market exclusivity through November 2022.

Pfizer broke ground at its Andover, Massachusetts campus on a clinical manufacturing facility for complex biologics and vaccines.

A study published in BMJ indicates that rheumatic patients with anti-infliximab antibodies may have a similar cross reaction to infliximab biosimilars.

Planning ahead is key to enabling a continuous and secure supply chain that adapts to changes in market demand.

Biopharmaceutical manufacturers continue to put quality at the forefront of their relationships.

In Phase III clinical trials, ixekizumab showed to be superior to etanercept and placebo in treating moderate-to-severe plaque psoriasis.