Outsourcing

Innovation speeds discovery, drives down costs, and improves productivity.

Despite some progress, the industry is still in a wait-and-see mode regarding the administration, Congress, and FDA.

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 Bridgewater facility will provide a range of contract services for biopharmaceutical and pharmaceutical manufacturers, and also serve electronics chemicals suppliers.

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

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.

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

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.

IDBS described benefits and best practices for laboratory electronic data systems.

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

Fagron Sterile Services has voluntarily recalled three lots of Succinylcholine Chloride 20mg/mL 5mL syringe to the hospital/clinic level.

The success of a truly integrated continuous processing platform relies on the collaborative efforts of upstream and downstream specialists.

Although widespread adoption of continuous bioprocessing has been slow, some processes have been an exception.

Microdermics will focus on product development and clinical activities of new drug delivery methods, while Vetter’s primary role will be in the fill and finish aspect.

BioVectra will open its new microbial fermentation and complex chemistry site, including the capability to handle high-potency APIs, by the end of 2017.

The authors examine the selection process of the contract manufacturing–pharmaceutical relationship and the communication challenges that pharmaceutical firms face prior to and during the CMO selection process.

Andrea Zobel, senior director of product management, clinical trial supply, and logistics at PAREXEL International, examines key issues and questions that sponsors and contract partners must address.

Good project management, budgeting, planning, and clear documentation are the only ways to prevent overruns and project failure.

BioPharm International speaks with a CMO to find out how it is coping with capacity challenges, regulatory authority scrutiny, supply chain reliability, and new requests from clients to incorporate continuous manufacturing into processing lines.

Contract manufacturers prepare for anticipated biosimilars manufacturing demands through expansion and acquisition.

The article reviews strategies for firms with or without existing in-house capacities and the pros and cons for outsourcing bio/pharmaceutical development and manufacturing.

Effective communication between contract manufacturing organizations and pharmaceutical company clients relies on well-defined master service and quality agreements.

FDA’s focus on the quality culture and its request for quality metrics may ensure a successful company-CMO relationship.

This article reviews experiences with the outcome of in-house audits, audits by third parties, and purchased audit reports.

Operated by BioOutsource, Sartorius’ subsidiary, the Glasgow, UK-based service center will offer physicochemical properties and structural attributes testing and allow clients to perform structural and functional analyses in parallel.

CMOs may be gaining as strategic partners to large bio/pharma companies, but they have a much harder path to navigate.