Helsinn, Samsung Biologics, LGM Pharma, Wacker, PCI Pharma Expand

By Miranda Greenberg -

July 30, 2020

The latest from CDMOs, CMOs, and suppliers featuring Helsinn, Samsung Biologics, LGM Pharma, Wacker, PCI Pharma Services, Thermo Fisher Scientific, Avid Bioservices, and others.

Chemicals/Chemical API Manufacturing

Helsinn Advanced Synthesis Opens Dedicated Anticancer Bay
Helsinn, a Lugano, Switzerland-based pharmaceutical company focused on cancer-care products, reports that its manufacturing subsidiary, Helsinn Advanced Synthesis SA (HAS), a CDMO of active pharmaceutical ingredients (APIs), advanced intermediates, high-potency APIs, and anticancer compounds, has opened a dedicated anti-cancer bay at its manufacturing plant in Biasca, Switzerland.

The new anticancer bay will be used for the development, analysis, and manufacturing of clinical and commercial anticancer APIs. The new bay includes: three reactor units (an 800-L Hastelloy; 1,000-L glass lined; and 1,200-L Hastelloy allowing for production scale-up to approximately 50 kg) a conic reactor (150-L capacity) for loading operations in a closed system; one Hastelloy filter dryer (0.5-m² filtering surface); and 1 mill. In addition, there are five gloveboxes for product handling. The anticancer facility can handle reaction temperatures from -80 °C to +140 °C and has a dedicated warehouse.

The Swiss Agency for Therapeutic Products inspected the new facility in June 2020 and approved manufacturing to start. The first project was initiated in late last month (June 2020).

In 2012, HAS built its first dedicated anti-cancer plant that could manufacture compounds with an occupational exposure limit (OEL) down to 50 ng/m³ and had a small, medium and large-scale bay. In 2016, a new expansion was proposed to build a larger-scale bay. After receiving positive results from a feasibility study, a detailed engineering plan was put together in 2017 while procurement began. The project spanned three years and involved more than 100 external suppliers, resulting in the largest anticancer bay at HAS.

Source: Helsinn


Biologics manufacturing

Thermo Fisher, Lyell Immunopharma Form Cell Therapy Mfg Pact
Thermo Fisher Scientific and Lyell Immunopharma, a San Francisco-based cell-therapy company, are partnering to develop manufacturing processes for cancer cell therapies.

The intent of the strategic partnership is to gain access and insights into emerging and existing technologies to improve the consistency of manufacturing operations. This alliance also provides the opportunity for further strategic collaboration in supply-chain and commercialization pathways.

The companies will work together to improve the fitness of T cells and support Lyell with its development of an integrated platform, including reagents, consumables and instrumentation.

Source: Thermo Fisher Scientific


CMIC Establishes a Biologic CDMO Business in Japan
CMIC Holdings Co. Ltd. (CMIC) has established CMIC BIO, a fully owned subsidiary that offers CDMO services for biopharmaceutical drug substances.

CMIC Bio has a single-use facility in Shizuoka, Japan for process development and manufacturing of antibody drugs using mammalian cell lines. The facility will be in full-scale operation from October 2020.

Source: CMIC Holdings Co. Ltd.


Abzena Receives $10M Investment from Biospring Partners
Abzena, a biologics CDMO, has received $10 million in funding from Biospring Partners, a New York based investment firm.

The company says the new capital will allow Abzena to accelerate its growth plans. Abzena says it had 80% revenue growth and tripled manufacturing capacity in the first half of 2020.

Source: Abzena


Wacker To Expand Biologics Capacity at Amsterdam Site
Wacker, a Munich, Germany-based chemical company, is investing in its production facilities for biologics, LMPs (live microbial products), and vaccines at its Amsterdam site.

Projects include the construction of a new fermentation line with a volume of 1,500 liters as well as the setting up of new cleanroom structures in the 270-liter fermentation line. The investment price is a mid-double-digit million-euro amount.

The construction of a new fermentation line with a volume of 1,500 liters is planned, which, after a transition period, will eventually supersede an existing 1,500-liter line. At the same time, cleanroom structures in the area of the 270-liter production line are to be created. The existing cleanrooms are to be renovated and re-equipped with equipment. Among other improvements, new utility supplies are planned, such as water for injection. These measures will contribute to preparing the plant to produce new classes of actives, such as pDNA and mRNA-based vaccines.

Source: Wacker


Formulation Development/Drug-Product Manufacturing

Samsung Biologics To Expand Aseptic Filling, Lyophilization Capacity
Samsung Biologics plans to expand its drug-product capability for aseptic filling with by building a flexible filling line and adding two additional lyophilizer units with 41.2-m2 chambers.

The filling line is expected to begin operations in the second half of 2021, and the expanded lyophilization line will become operational in the first half of 2022. Through this expansion, Samsung Biologics will add small-scale cartridge- and syringe-filling to its drug-product offerings and increase its total lyophilization capacity by 246% of current capacity. The company expects to demonstrate its ongoing services for its clients and existing partnerships in addition to procuring new orders.

Source: Samsung Biologics


LGM Pharma Acquires CDMO Business of Nexgen Pharma
LGM Pharma, a Nashville, Tennessee-headquartered active pharmaceutical ingredient (API) supplier, has acquired the formulation development and drug-product contract manufacturing business of Nexgen Pharma, an Irvine, California-based company developing and manufacturing solid dose, powder, semi-solid, and liquid prescription and over-the-counter drugs.

The aquisition brings LGM Pharma’s knowledge in API sourcing, distribution and supply-chain management with Nexgen Pharma’s drug-product CDMO services. The combined firm will continue to be known as LGM Pharma.

The acquisition brings Nexgen’s manufacturing and warehouse distribution facilities and employees in California and Texas to LGM Pharma, along with its formulation development, laboratory, and pilot-plant manufacturing employees and facilities in Colorado. In all, LGM Pharma is gaining 150 employees and more than 100,000 square feet of facilities, along with expertise in all aspects of pharmaceutical finished-product development and manufacturing.

Source: LGM Pharma and Nexgen Pharma


SCA Pharma to Expand Production Facility in Arkansas
SCA Pharmaceuticals, a Little Rock, Arkansas-headquartered company specializing in sterile compounding, plans to expand its operations in Little Rock, Arkansas with an investment of more than $10 million.

The investment will be used to double its current Little Rock workforce of 180 people, renovate an existing 42,000-square-foot facility, and construct an additional 20,000-square-foot facility adjacent to the existing facility. SCA also plans a 40% expansion of its Windsor, Connecticut facility.

Source: SCA Pharmaceuticals


Packaging

PCI Pharma Services Expands Services with New Facility in Berlin
PCI Pharma Services (PCI), a CDMO and contract provider of packaging services, has created a new Clinical Center of Excellence (COE) in Berlin Germany, which represents a new flagship site in Western Europe.

This is part of PCI’s global strategy to expand its clinical supply-chain network into continental Europe to complement offerings available at its UK and Ireland sites. The COE is expected to be completed in January 2021.

The Berlin COE will include 17,000 square feet of space dedicated to primary and secondary packaging, storage of pharmaceutical and biopharmaceutical therapies at all temperature ranges, and distribution. PCI says this capacity is positioned to service EU-based clinical trials.

Source: PCI Pharma Services


General

Avid Bioservices, Argonaut Form Alliance for End-to-End CDMO Services
Avid Bioservices, a biologics CDMO, and Argonaut Manufacturing Services, a CDMO, have entered into a co-marketing agreement to provide an integrated manufacturing service to include services for process development, drug-substance manufacturing, and drug-product manufacturing.

Under the non-exclusive agreement, the companies will offer Avid’s process development and drug-substance manufacturing services in tandem with Argonaut’s parenteral drug-product fill-finish services, to support parenteral drug products in clinical studies.

Source: Avid Bioservices


ApiJect Names New CEO
Apiject Systems America, a Stamford, Connecticut-based provider of prefilled syringes, and its subsidiary, RAPID USA (Rapid Aseptic Packaging of Injectable Drugs), has named Franco Negron Chief Executive Officer (CEO) of both organization, effective July 6, 2020.

Most recently he served as President of Commercial Operations at Thermo Fisher Scientific. He joined the company in 2017 when it acquired his previous employer, Patheon Pharmaceuticals, where he served as President of Development & Commercial, North America. Shortly after the acquisition, he was named President of Commercial Operations for the newly formed Pharma Services Group. Mr. Negron’s experience in the pharmaceutical industry spans nearly 25 years, including serving as Vice President of Manufacturing and Supply at Valeant Pharmaceuticals, Global Vice President in Novartis’ Consumer Health Over-the-Counter and Pharmaceutical Products Division, and Site General Manager at McNeil Consumer Healthcare.

Mr. Negron succeeds ApiJect Systems America and RAPID USA co-founder Jay Walker, who had been serving in the dual role of Chairman and CEO. Mr. Walker will continue to serve ApiJect and RAPID USA as Executive Chairman.

Source: ApiJect Systems America


Jubilant Biosys Merges With Jubilant Chemsys
Jubilant Biosys Ltd, a subsidiary of Jubilant Life Sciences Ltd, has completed a merger with its sister company, Jubilant Chemsys Limited, based in Noida, India. The combined entities will now operate as Jubilant Biosys Limited.

The merger will simplify operations and provide a single brand access for a range of development services. Jubilant Biosys had earlier announced investment in building new research facilities in Greater Noida and in Bengaluru, India for its functional services and drug- discovery services.

Source: Jubilant Biosys Limited