Outsourcing

Samsung BioLogics’ second facility adds 152,000 L of mAb drug substance capacity.

Predicted areas of growth include flow chemistry, fermentation, repatriation of overseas funds, oncology, and API/product integration, but the rate of change is unclear.

Investments include the installation of development and analytical equipment to support the development of highly potent APIs as well as a new 2800-liter hydrogenator and 1500-mm diameter centrifuge for increased flexibility and capacity within the manufacturing plant.

The collaboration will focus on developing a novel and differentiated challenge model for respiratory syncytial virus.

CordenPharma will integrate the Hospira Boulder API manufacturing facility into the CordenPharma Colorado network for highly potent and oncology APIs.

Hitachi Chemical Advanced Therapeutics Solutions will expand its PCT service platform for cell therapy by adding GMP manufacturing and cleanroom capacity in Allendale, NJ.

Under an agreement, ProBioGen will develop a stable cell-line for and manufacture an anti-cancer antibody for Chiome using its proprietary cancer cell-killing technology.

Cytel, a biometrics CRO and clinical trial software provider, announced that it will be adding a new location for clinical development in Basel, Switzerland.

PCI Pharma Services, a pharmaceutical outsourcing services provider, will acquire Millmount Healthcare, a pharmaceutical and healthcare contract packaging services provider, to expand its European services.

CDMOs have established strategies for handling new chemical entities with unknown biological activity.

Mergers and acquisitions are positive for the CDMO industry, but there is a downside.

The acquisition broadens the CDMO’s preclinical and clinical offering to include bioanalytical and drug discovery services.

Additional reactor capacity and a wastewater processing plant increase API manufacturing capacity at the Cambrex site in Kalskoga, Sweden.

ADC Bio announces plans to expand into clinical and commercial drug manufacturing for ADCs.

Ajinomoto Althea opens manufacturing suites in new high potency and antibody drug conjugate commercial facility.

The acquisition adds to Catalent’s capabilities in biologics development, analytical services, manufacturing, and finished product supply.

Matching the production requirements of a bio/pharma company with the manufacturing capabilities of a CMO is a delicate balance, requiring attitude shifts on both sides of the table.

Forced degradation studies can identify stability problems for drug substance and drug products.

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

Regulatory outsourcing can result in improved compliance, greater transparency, higher productivity, increased cost-effectiveness, and desired strategic outcomes.

CDMO Micro-Sphere is investing CHF 21 million (approximately $21.63 million) into the expansion of its GMP manufacturing capabilities at its Swiss facility.

Regenerative thermal oxidation (RTO) has become a common solution to treat volatile organic compounds (VOC) and hazardous air pollutants (HAP) present in the emissions of many pharma production processes. Regenerative thermal oxidation devices used to treat halocarbons should be designed to prevent corrosion. Anguil Environmental Systems explains best practices for addressing potential fail points in the materials of construction when designing process emission handling systems.

Cambrex is investing $24 Million in new, highly potent API manufacturing capacity at its Charles City, Iowa site.

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

Amid contentious debate about “fake news,” peer-review papers offer vital, objective insight.

The merger enhances STA’s end-to-end capabilities as a full-service contract development and manufacturing organization.

CMOs must embrace flexibility in their technology decisions and business arrangements.

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.