Lonza, WuXi Biologics, Catalent, and More Expand; CordenPharma Completes Audit

A roundup of the latest news from suppliers, contract development and manufacturing organizations and contract manufacturing organizations, featuring Lonza, CordenPharma, Catalent Pharma Solutions, WuXi Biologics, PCI Pharma Services, and Kingchem Life Science, Rentschler, and Piramal.


Chemicals/Chemical API Manufacturing

Piramal Pharma Solutions Completes New cGMP Kilo Lab Suite
Piramal Pharma Solutions (PPS), a contract development and manufacturing organization, has completed its new cGMP kilo lab suite at its active pharmaceutical ingredient (API) site in Ennore, Chennai, India. The suite will formally open on December 1, 2018.

Ennore is an API site in the PPS integrated site network, with capabilities from early development through commercial manufacturing, with an available capacity of over 300 kL. The site supplies key starting materials, registered starting materials, advanced intermediates and APIs for both large pharma and biotechnology firms, in North America, Europe, and rest-of-world markets.

Source: Piramal Pharma Solutions


CordenPharma Completes SafeBridge Recertification Audit in Colorado
CordenPharma, a contract development and manufacturing organization of active pharmaceutical ingredients (APIs) and drug products, has successfully completed a potent compound recertification audit by SafeBridge Consultants at its Boulder, Colorado.

Certification has been maintained since first awarded in 2013. CordenPharma acquired the site from Hospira, a Pfizer company, in late 2017 after announcing the companies’ agreement in October 2017, which included a multi-year supply arrangement. The site produces active pharmaceutical ingredients (APIs) and intermediate products with specialized capabilities in small- to medium-scale highly potent and cytotoxic API manufacturing.

The onsite assessment included the evaluation of physical plant features, programs, exposure controls, procedures and practices applied towards the manufacturing of highly potent APIs, consisting of a review of over 60 elements.

Source: CordenPharma 


Kingchem Life Science Acquires Fine Chemical Manufacturer Apiscent Labs
Kingchem Life Science, an Allendale, New Jersey-headquartered contract manufacturing organization, has acquired Apiscent Laboratories, a St. Francis, Wisconsin-headquartered manufacturer of flavors, fragrances and pharmaceutical chemicals. A total investment of over $3 million was made regarding the business assets and the real estate.

A new company, Kingchem Laboratories — a subsidiary of Kingchem Life Science— will continue to employ all current staffing. In addition, the company says at least 10 new employees, including quality assurance, research and development (R&D), and production supervisors and operators, will be hired in the coming months.

The acquisition gives Kingchem its initial R&D and GMP-manufacturing capabilities in the US. Further investments of at least $2 million are planned for the Wisconsin facility over the next one to two years for equipment upgrading, capacity expansion, as well as construction of a new GMP kilo lab.

Source: Kingchem

Biologics Manufacturing

WuXi Biologics Begins Construction of Biologics Innovation Center in China
WuXi Biologics, part of WuXi AppTec, a Shanghai, China-headquartered contract service provider, has begun construction of a global innovation center in Shanghai.

The new biologics center will integrate biologics discovery, development, clinical, and commercial manufacturing, which will be built to meet global cGMP standards while implementing modular and flexible design. This facility will have 1.6 million-square-feet and will accommodate more than 3,000 scientists.

Source: WuXi Biologics


Lonza Opens Collaborative Innovation Center in Israel
Lonza Pharma & Biotech has opened its Collaborative Innovation Center (CIC) in the Haifa Life Science Park of Israel. Lonza says the CIC acts as a hub for partnerships to identify and accelerate new solutions for biopharmaceutical manufacturing.

The 1,000-square-meter facility, including lab space equipped with bioprocessing and analytical equipment, is being made available to collaborating partners as a test bed for new ideas and technology. In addition to infrastructure, Lonza says it will make funding and in-house expertise available for collaborative research into strategic areas of application relevant to a variety of biopharmaceutical development needs.


Source: Lonza


Formulation/Drug Product Manufacturing 

Rentschler Inaugurates New Fill and Finish Facility
Rentschler Fill Solutions GmbH, a contract development and manufacturing organization (CDMO), has inaugurated a new facility in Rankweil, Austria for aseptic filling and freeze-drying drug products.

Rentschler Fill Solutions expects approval from the US Food and Drug Administration in 2019.

Source: Rentschler Fill Solutions



Catalent Expands Clinical Packaging Capabilities in China
Catalent Pharma Solutions has reached the commissioning stage for expansion of its primary packaging capabilities at its clinical facility in Shanghai, China and says the work is scheduled to be completed by the end of 2018.

The expansion includes a new automated, high-speed bottling line suitable for capsule and tablet products. The line will increase packaging capacity by up to 100 bottles per minute and provides for quick and easy changeover, according to information from Catalent.

This expansion follows the announcement that work is underway by the company to open a new clinical facility outside of Shanghai’s free trade zone. The new facility is expected to be completed in early 2019 and will join the company’s existing three clinical packaging facilities in the Asia Pacific region.

Source: Catalent Pharma Solutions 


PCI Pharma Services To Expand US Center of Excellence
PCI Pharma Services, a contract development, manufacturing, and packaging organization, plans to expand its clinical site at Rockford, Illinois by 30,000 square feet. Construction of the expanded clinical services facility began on November 12, 2018. The site is one of two US-based PCI locations supporting investigational medicinal products, complementing facilities in the UK, Europe, and Australia.

The facility expansion at the Rockford location will provide 30,000-square-feet of additional space in support of primary and secondary packaging and labeling operations for investigational medicinal products at the clinical services center of excellence, including a dedicated 2-8 degree Celsius packaging suite for cold-chain products.

The expanded building is expected to open for business in late 2019 following internal fit-out and a period of validation and licensing.

Source: PCI Pharma Services



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