Manufacturing

The authors describe the impact of the knocking of the pgi gene of the wild type MG1655 strain on the growth kinetics of plasmid-free and plasmid-bearing cells.

In this article, the author reviews some of the techniques that can yield valuable information on protein stability, focusing specifically on protein aggregation. Emphasis is placed on the enhanced information made available when technologies are used orthogonally, and the alignment of different approaches with specific stages of the biopharmaceutical development workflow.

Novasep is building a new synthesis laboratory and adding capacity for kilogram-scale batches of synthetic molecules that are needed for biological testing and preclinical trials, at its Pennsylvania, US facility.

Serialization, combination products, emerging markets, outsourcing, TVF, and adherence are identified as the key themes in drug delivery and packaging for 2016.

Takeda Pharmaceuticals announced the acquisition of a biopharmaceuticals manufacturing plant in Minnesota.

The Cell Therapy Catapult, University of Birmingham, and Cancer Research Technology collaborate on CAR-T cell immuno-oncology therapy development.

FDA discusses a new program that allows pharmaceutical companies to submit proposals for new manufacturing technology.

BioPharm highlights the monoclonal antibodies that may gain United States regulatory approval in 2016.

In semiconductor manufacturing, for example, a thorough understanding of process variation allows companies to manufacture circuits with billions of transistors at high yields. These variations are translated into a set of design rules, which help ensure that designs will be manufactured successfully and meet safety and other regulatory requirements.

The authors explore the use of precipitation using polyvinyl sulfonic acid and zinc chloride in place of capture chromatography to reduce the cost of goods in the insulin manufacturing process.

mstay/Getty ImagesBiopharmaceutical manufacturing involves a series of complex unit operations linked together to provide high-purity, biologic actives with specifi

Traceability and transparency will remain elusive if manufacturers continue to approach serialization projects on a case-by-case basis.

The results of an industry workgroup’s examination of EMA’s guide on shared facilities are presented.

The authors conclude that miniature bioreactors can adequately predict the cell culture kinetics in scaled-up reactors using equal mixing times.

Boehringer Ingelheim announced it will establish a new biopharmaceutical production facility in Vienna.

Samsung BioLogics begins construction on their third facility in Songdo, Korea.

The agency has launched a new web platform to foster scientific innovation.

The company will in-license a novel antibody, which has a conformation that is associated with increased therapeutic efficacy.

TxCell signs strategic agreement with MaSTherCell for European manufacturing of its cell therapy products.

FDA sets a July 2016 deadline for the final version of the rule on labeling changes for approved drugs and biologics.

Paragon Bioservices entered into a contract with the International Aids Vaccine Initiative for the process and analytical development and cGMP manufacturing of an HIV vaccine candidate.

Seqirus, CSL Limited’s influenza vaccine business, announced the opening of their corporate headquarters in the United Kingdom.

Biogen, Genentech, Johnson & Johnson, Novartis, and Patheon publicize their support for action on climate change.

Subjective visual evaluation of freeze-dried products can be quantified through mechanical methods of characterizing the properties these materials.

Use of a subspace model is a viable method to characterize process space variables and optimize process performance.

Growing differentiated cells from stem cells may now be a bit easier than before, thanks to the findings from a new study on the production of liver cells. The study, backed by the Centre for Regenerative Medicine and published in Stem Cell Reports, finds that laminins may be a crucial element for the successful clinical-scale production and culture of stem cell therapies. The UK Regenerative Medicine Platform, the European Union Seventh Framework Programme, and the German Federal Ministry of Education and Research funded the research.

The University of Sheffield has appointed Cobra Biologics to advance novel fusion protein technology into Phase 1 clinical trials.

There’s renewed optimism in the biomedical research community that years of effort finally may begin to pay off for developing cutting-edge gene and cellular treatments for debilitating and life-threatening conditions. Jill Wechsler reports.

The 2015 UPS supply chain survey suggests that pharma companies need to improve cost control and planning for unexpected events.

Baxter expands capacity for lyophilized cytotoxic oncology therapies at its fill/finish facility in Halle, Germany.