Manufacturing

Consider equipment design, transfer systems, and maintenance when operating isolators for sterile manufacturing of pharmaceutical products.

Careful design, planning, and record keeping are needed for cleaning and changeover in multiproduct pharmaceutical facilities.

Consider current large-scale practices for oligonucleotide synthesis as a basis for improving commercial-scale platform strategies.

Researching excipient grades and sources, as well as screening suppliers and materials, form the basis of programs to mitigate risk.

This paper discusses what causes cross-linking, how cross-linking is addressed with addition of enzymes, and consideration for occasional high results that can be obtained during release testing.

CDMOs must consider challenges associated with the complexity of contract pharmaceutical manufacturing when approaching digitalization projects.

Abcam has purchased Applied StemCell’s (ASC’s) gene editing platform and oncology product portfolio, adding comprehensive cell editing capabilities and engine to support expansion of existing “off-the-shelf” cell lines.

WuXi’s R&D team will be developing and manufacturing 2019-nCoV-neutralizing antibodies at the company's four GMP facilities.

The new facility, to be operated under the newly formed CDMO, The Center for Breakthrough Medicines, will be located in King of Prussia, PA, and will increase manufacturing capacity for cell and gene therapies.

The agreement centers around the development of new stem-cell derived allogeneic T-cell therapies for the treatment of cancer.

GE Healthcare Life Sciences’ new facility for cell and gene processing supplies will be open in 2022.

A development and manufacturing partnership with Thermo will allow Civica to expand its internal pipeline of medications for use in emergency and critical care in the United States, further preventing the risk of drug shortages.

The formation of the new gene therapy company stems from the progress and success of Nationwide Children’s Hospital’s clinical manufacturing and gene therapy work.

The next-generation gene editing system can be applied to the development of novel cell and gene therapies.

Tracking and implementing label changes are crucial to the lifecycle of a marketed drug product.

Achieving effective manufacturing processes and sufficient capacity remains a top priority across a diversified biologic drug pipeline.

As mergers continue and operations become more complex, simplifying procedures and training can prevent costly morale, quality, and compliance problems.

The therapy is currently approved in the EU as a gene therapy for the treatment of patients 12 years and older with transfusion-dependent β-thalassemia.

Phillips-Medisize has announced that it is expanding its current Global Innovation and Development (GID) site in Struer, Denmark, to include a dedicated manufacturing development and clinical build unit.

The new site can manufacture oligonucleotide APIs at large scale.

With a positive employment market, some bio/pharma professionals explore options for career advancement.

Data collected through the Industrial Internet of Things enable predictive maintenance.

Advanced dynamic process control of a fluid-bed granulation process using PAT data improves product quality.

Pharmaceutical companies work toward a circular economy by using sustainable packaging.

Regulatory mandates, niche diseases, and patient-centric solutions have all impacted pharma packaging over the years and are expected to help shape the future of the sector.

PTE looks ahead to 2020’s edition of Pharmapack-the pharma industry’s dedicated packaging and drug delivery event.

A coalition establishes a secure, direct link between a physical tablet and a digital backend for supply chain integrity.

Sartorius and the German Research Center for Artificial Intelligence have established a research laboratory for AI in the biopharmaceutical industry.

Predictive and prescriptive maintenance improve pharmaceutical manufacturing equipment effectiveness.

The acquisition expands Charles River’s scientific capabilities in cell therapy development.