Lonza, Piramal, LSNE, Tergus Pharma Expand; Aptar Makes Two Acquisitions
The latest news from CDMOs, CMOs, and suppliers featuring news from Lonza, Piramal Pharma Solutions, Tergus Pharma, LSNE, Aptar, and Rentschler Fill Solutions.
Chemicals/Chemical API Manufacturing
Lonza To Expand HPAPI Development and Mfg Capacity
Lonza has announced an expansion of its Visp, Switzerland site to increase highly potent active pharmaceutical ingredient (HPAPI) capacity.
The expansion adds two 4-square-meter multipurpose production lines for HPAPI manufacturing to complement Lonza’s existing range of production capacities from lab to large commercial scale. A subsequent capacity optimization will also improve Lonza’s flexibility in existing production lines.
Lonza has entered into a long-term manufacturing agreement with AstraZeneca, which will be supported by the new facility enabling the delivery of a number of products from across its portfolio. Remaining capacity will allow Lonza to expand the offer to other clients.
The HPAPI capacity expansion is expected to be on line by July 2020.
Source: Lonza
Piramal Pharma Solutions Opens $10-Million HPAPI Production Wing
Piramal Pharma Solutions (PPS), a contract development and manufacturing organization, has opened a new wing at its Riverview, Michigan site dedicated to the production of high-potency active pharmaceutical ingredients (HPAPIs) for a total investment of approximately $10 million.
The new facility includes a quality control/analytical lab, two kilo-labs and doubles the amount of office space. The new wing was designed with the required engineering controls and containment solutions to handle HPAPIs with occupational exposure limits (OELs) of < 1 mcg/m3 and as low as about 20 ng/m3. Materials will primarily be produced in this new wing at kilo-lab scales; lots of < 5 kilos can be produced in this new facility, according to PPS.
Previously, PPS’ Riverview site has had the containment capability and engineering controls to safely handle HPAPIs with OELs down to 1 mcg/m3, at scales ranging from grams to about 250 kilos.
The site now operates twelve hours a day, seven days a week, and the company says the site is heading toward being a full 24/7 site. The expansion has increased the local staff from 80 to 127 people, with a projected total of approximately 150 employees in the near future, including staffing of PhD and BS degree scientists, plus manufacturing operators and other skilled workers, according to PPS.
The company says more expansions are forthcoming as there is additional real estate available on the site for added capacity and new capability enhancements.
Source: Piramal Pharma Solutions
Formulation Development/Drug Product Manufacturing
Rentschler Fill Solutions Names New CEO
Rentschler Fill Solutions GmbH, a contract development and manufacturing organization and aseptic fill–finish service provider, named Dr. Friedrich Sernetz as Chief Executive Officer (CEO), effective June 1, 2019. Dr. Sernetz has more than 20 years of experience as a manager in the pharmaceutical and chemical industries.
Dr. Sernetz was previously with Laboratoire FAMAR in Paris, France where he was Chief Commercial Officer (CCO) and served as interim co-CEO. Prior to this position, he was CCO at Aenova and Country Head Austria at Sandoz. Dr. Sernetz managed worldwide purchasing at Ratiopharm and later was Chief Procurement Officer with the Holzkirchen branch of Sandoz. Before that, he was the Managing Director at Diosynth after starting his career at Hoechst.
The appointment follows the scheduled closure of a aseptic fill–finish facility of Rentschler Biopharma SE, located in Laupheim, Germany at the end of June 2019. Based on a strategic alliance agreed to in mid-2017, Rentschler Biopharma will be focusing on the manufacturing of drug substances while Rentschler Fill Solutions will focus on the aseptic filling of biopharmaceuticals.
The Rentschler Fill Solutions facility in Rankweil, Austria is designed for the production of small- to medium-sized batches of up to 60,000 vials. The company says it offers fill–finish services that cover the entire range from GMP-compliant aseptic filling and freeze-drying to extensive analytics.
Source: Rentschler
Tergus Expands With New Commercial Manufacturing Facility
Tergus Pharma, a service provider for topical pharmaceutical research, drug development, testing and manufacturing, has announced a 100,000-square-foot building for its new headquarters and plans to invest to expand into commercial manufacturing. Tergus is partnering with Great Point Partners (GPP), a Connecticut-based healthcare investment firm for the expansion.
Construction of the new commercial manufacturing building, located in Raleigh-Durham, North Carolina, will begin in July 2019. The facility will include clinical trial material (Phases I through III) supplies and commercial manufacturing capabilities to expand current capacity by over 400%. Tergus plans to open the new facility in early 2020.
Tergus provides topical formulation development, in vitro permeating testing, in vitro release testing, skin biology, analytical services, and clinical trial materials manufacturing services for branded and generic dermatology products.
Source: Tergus Pharma
LSNE Acquires Sterile Injectables Manufacturing Facility
Lyophilization Services of New England (LSNE), a contract lyophilization development and manufacturing organization, has completed its acquisition of a sterile injectables manufacturing facility in Leon, Spain. The new site, LSNE-Leon, will be in addition to LSNE’s existing manufacturing capabilities and allow for its services in Europe.
In addition to pre-filled syringe, ophthalmic and sterile bulk lyophilization capabilities, the new facility will focus on pharmaceutical products that have complex requirements, such as emulsions, suspensions, liposomal formulations, and nanoparticle products. It will include four high-speed, automated aseptic fill lines and commercial-scale lyophilization for the manufacture of clinical and commercial drug products.
This is a second recent acquisition for the company. In April 2018, LSNE acquired a 37,000-square-foot cGMP aseptic fill–finish facility in Madison, Wisconsin.
The LSNE-Leon facility is located northwest of Madrid in Spain’s pharmaceutical hub. It has completed US Food and Drug Administration and Spanish Agency of Medicines and Medical Devices inspection and is able to support large-scale commercial production in both the US and European Union.
Source: LSNE
Packaging
Aptar Acquires Nanopharm and Gateway Analytical for Combined $50 Million
Aptar, a supplier of dispensing, sealing and packaging solutions, has acquired two pharmaceutical services companies, Nanopharm Ltd. and Gateway Analytical LLC, for a combined enterprise value of approximately $50 million.
These acquisitions are part of Aptar’s strategy to support pharmaceutical and biotech customers to accelerate and simplify their complex product developments. Both companies bring complementary, value-added and differentiated analytical, testing and development services in all stages of drug development and commercialization.
Nanopharm, located in Newport, UK, is a science-driven provider of oral and nasal inhaled drug product design and development services. Gateway Analytical, located in Gibsonia, Pennsylvania, provides particulate detection and predictive analytical services to customers developing injectable medicines.
Source: Aptar
