Manufacturing

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.

ProBioGen and Lava Therapeutics have closed the cell line development and manufacturing agreement for Lava’s novel bispecific antibody lead candidate.

Catalent’s FlexDirect service offers sponsors multiple delivery options from a single inventory.

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.

The trial will test experimental stem-cell treatments against biologic therapies for severe forms of relapsing multiple sclerosis.

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 Ireland-based company can now offer complete elemental impurities testing services.

Molecular taggants from Applied DNA Sciences and Colorcon’s Opadry coating target counterfeit and falsified medications.

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.

By consolidating legacy buildings, Colorcon enhances environmental and production efficiencies at West Point, PA facility.

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

The expansion plans to build upon the company’s high potent drug manufacturing and development capabilities, including both clinical and commercial supply.

Long a staple for quality by design and solid dosage form manufacturing, design of experiments is becoming an integral part of biopharma upstream process development.

Through the collaboration, Charles River plans to expand its suite of authentic human cells by utilizing Bit Bio’s target discovery, validation, and screening services to further the development of therapies with a higher chance of success in patients.