Outsourcing

Research suggests that on-site audits are becoming less meaningful because suppliers are less willing to devote time to them.

Requirements for early- and late-stage trial manufacturing may differ, but complying with good practices, maintaining blind studies, and considering logistics remain crucial at all times.

Eric Jayjock, Patheon’s director of continuous manufacturing, discusses the CDMO’s plans for its new continuous manufacturing business.

Successful development requires coordinating and aligning drug and device design, focusing on a complete drug delivery system that meets patients’ needs.

TraceLink’s Graham Clark, director of contract supplier relationships and cofounder, and Brian Daleiden, vice-president of industry marketing, shared insights into industry’s serialization readiness as well as recent trends and developments with Pharmaceutical Technology.

Advanced digital ledger technologies offer potential solutions, but are still several years away from practical use.

The contract development and manufacturing organization (CDMO) Aesica Pharmaceuticals has had a serialization program in place for the past five years, and recently installed capabilities for serialization at all its packaging facilities.

Elevating the project management function can improve transparency and enable companies to react faster to internal and external change.

Catalent Applied Drug Delivery Institute announced a partnership with Rutgers University to examine the challenges of pediatric drug formulation and delivery.

Contract manufacturers await a promising pipeline of drug products to jump-start stagnant growth.

The new center will help biopharmaceutical and pharmaceutical manufacturers with product development.

Catalent expands the scope of the OptiForm Solution Suite to bridge gap from late-stage discovery to Phase I trials.

The addition of 20,000 sq. ft. of manufacturing and office space increases Avecia’s Milford, Ma, oligonucleotide capacity to 3.0 mol.

Alcami will move its headquarters to Durham, NC while maintaining its manufacturing and laboratory operations in Wilmington, NC.

Respondents cited instrument maintenance and downtime, complexity of testing requirements, and time-consuming sample preparation as the top challenges in their laboratories.

Pfizer’s new format of ibuprofen (AdvilR Liqui-GelsR Minis) uses Catalent’s softgel technology to deliver the formulation in a more concentrated fill, resulting in smaller capsules.

GE Healthcare’s Dharmacon business and CordenPharma contract manufacturing enter a strategic collaboration to accelerate the oligonucleotide development process.

Recro Gainsville expands its tableting capacity with the addition of a tablet press and film coater.

The suite installation increases PCI’s Hay-on-Wye site’s serialization capability to support clients in advance of meeting the implementation dates of the European Falsified Medicines Directive.

A $5.5 billion acquisition brings Capsugel’s oral dosage delivery capabilities to Lonza’s portfolio.

Samsung BioLogics signs $55.5 million agreement to manufacture tildrakizumab for Sun Pharma.

Patheon will add spray drying, sterile manufacturing, and packaging capabilities to four facilities.

How has the bio/pharmaceutical contract manufacturing industry evolved over the years and what does the future hold?

As pharma models changed during the past 40 years, contract manufacturing capacity and services evolved to meet demand.

The more pharma science and technology change, the more business and policy concerns stay the same.