Manufacturing

The company is opening two offices in the United States that will offer serialization, automation, and process control services.

Irvine Scientific’s new product range includes chemically-defined, serum-free media, to increase productivity of viral vectors and recombinant proteins in suspension cultures.

Agilent Technologies announces plans to build a new oligo manufacturing facility in Colorado that will double current capacity.

Jacobs Engineering will provide engineering and construction services to expand the Novartis site in Huningue, France.

Zika vaccine development is hindered by technical challenges and funding shortfalls.

Catalent Pharma Solutions teamed with Zumutor Biologics to develop antibodies with enhanced ADCC activity.

Jacobs Engineering Group was awarded a contract to provide engineering services and procurement for Alnylam Pharmaceuticals’ new manufacturing facility in Norton, Massachusetts.

Experts discuss recent advances in cell viability testing methods in bioreactors.

An MIT-developed system uses microbes for manufacturing small amounts of vaccines and other therapies.

Quality, flexibility, and cost savings are driving use of perfusion technology in biosimilars manufacturing.

Multiple methods are required for detecting and removing protein impurities.

Susan Schniepp, Distinguished Fellow at Regulatory Compliance Associates, discusses the regulatory requirements for improving manufacturing lines.

Industry experts discuss the challenges of using single-use systems in biopharma manufacturing.

The authors present a case study in which four single-use vessels were fitted to an existing bioreactor system.

The study demonstrates a systematic approach to stabilize PBS-formulated mAbs against freeze-thaw degradation.

Amgen discussed the drug-delivery approaches to two of its biologics in a recent second-quarter earnings call.

NIST’s monoclonal antibody reference material can be used as a standard for biopharmaceutical analytical quality control.

The Phase I trial will test Bavarian Nordic’s vaccine, which is manufactured using a vaccine vector based on smallpox.

The therapeutic candidate AZD8601is an investigational mRNA-based therapy that will be tested for its ability to regulate the protein that influences vascular tissue growth.

The mAb, in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, was granted a Breakthrough Therapy Designation from FDA for the treatment of multiple myeloma.

On July 25, 2016 Kite Pharma entered into an agreement with the University of California, Los Angeles,  (UCLA) to advance development of off-the-shelf allogenic T-cell therapies from renewable pluripotent stem cells. The company entered into an exclusive license agreement with UCLA for an artificial thymic organoid (ATO) cell culture system. The ATO replicates the human thymic environment to support efficient ex vivo differentiation of T-cells from primary and reprogrammed pluripotent stem cells.

The companies filed a BLA for romosozumab, an investigational monoclonal antibody for the treatment of osteoporosis.

The vaccine candidate has also won a Priority Medicines (PRIME) status from EMA.

The company manufactures biological drug products and intermediates for the allergy vaccine market.

The company opened a new service center in San Juan, Puerto Rico.

Zenith appointed Carlos Machado as serialization director to lead the company’s sales, operations, and post project support services.

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.