Highly Potent Drugs

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

CordenPharma is investing €10 Million in a new line at its Plankstadt, Germany site.

ChargePoint Technology is expanding its US presence by opening a new office in San Francisco.

The Spanish CDMO has installed a new automatic capsule filling machine at its EU GMP-approved plant in Pamplona, Spain

Takeda will build a new production facility at its existing Grange Castle site in Ireland.

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

Advances in chemical synthesis are enabling greener, more cost-efficient processes for API manufacturing.

Manufacturing will be carried out at the Pfizer Newbridge, Ireland, facility, which is now part of Pfizer CentreOne’s contract manufacturing network.

The new ISPE Containment Manual is a summary of the process involved in the manufacture of highly active or highly hazardous pharmaceutical substances.

The new commercial site, set to be located in Cambridge, Boston, MA, will serve clients on both the East and West Coast. It will also be the base for reaching new customers in the area.

Idifarma has announced a growth of more than 50% over the past two years. Revenue is expected to hit approximately EUR5.3 million in 2016, growing from EUR3.5 million in 2014.

PCI will be participating in two Speakers Corner slots at the ICSE Exhibitor Showcase.

CDMO Alcami adds HPAPI capacity and cryogenic capabilities to its Wisconsin facility.

Piramal Enterprises has entered into an agreement to acquire 100% stake in Ash Stevens all by cash for a consideration of $42.95 million plus an earn-out consideration capped at $10 million.

The design of Baxter BioPharma Solutions’ aseptic filling lines provides a case study in customizing containment systems for multi-product lines

The project involves installation of a small-scale pressured agitated nutsche filter dryer in glass, integrated in a high-containment isolator to achieve an occupational exposure limit of less than 1 microgram per meter cube, 8-hour time weighted average.

Hovione expands drug substance and HPAPI capacity in East Windsor, New Jersey.

Combining powder micro-dosing services with the Xcelodose technology, Capsugel offers capabilities in both North America and Europe.

The production of antibody-drug conjugates requires biopharmaceutical and chemical manufacturing, and conjugation capabilities.

Safe handling of HPAPIs requires determining exposure potential and selecting appro-priate containment strategies.

Highly potent or cytotoxic drugs require special handling

Manufacturing highly toxic compounds in a biopharmaceutical environment tests equipment and systems.

Collaboration will provide for unified development and manufacture of antibody drug conjugates.

The author lists five key areas to consider when selecting a CDMO to develop highly potent formulations.

Manufacturing of antibody drug conjugates requires high-containment solutions, such as high-performance aseptic isolators.

Liquid formulations in hard-shell capsules or softgels are becoming a popular option for HPAPIs because of advantages such as improved safety and lower risk of potential exposure and product cross contamination.

Biotech boom, niche markets, smaller batch sizes and high potency manufacturing are among the key trends shaping the pharmaceutical industry of the 21st century, according to Christian Treitel from Bosch Packaging Technology.

Hovione is investing in specialized formulation capabilities, beginning with the acquisition of a formulation facility adjacent to the current process chemistry and particle engineering facility in Loures, Portugal, the company announced on Oct. 19, 2015. This acquisition is a strategic investment to further boost development and manufacturing capabilities for both inhalation and oral dosage forms.

Scottish injectable-drug manufacturer Symbiosis Pharmaceutical Services plans to expand its sterile filling facility.

Steris Corporation’s steam sterilizer provides reliable decontamination for high-containment facilities.