Vectura in Proposed $1.3-Bn Buyout; Samsung Adds mRNA Mfg

By Miranda Greenberg -

June 3, 2021

The latest from CDMOs, CMOs, and suppliers featuring Vectura, Samsung Biologics, Lonza’s Bachthera, Avantor, Cytiva, Aceto, Danaher, Sharp, Stevanato Group, and others.

Chemicals/Chemical API Manufacturing

Aceto Acquires CDMO Cascade Chemistry
Aceto, a provider of specialty materials for life sciences and advanced technology end markets, has acquired Cascade Chemistry, a Eugene, Oregon-based CDMO of active pharmaceutical ingredients (APIs), regulatory starting materials, and advanced intermediates.

Cascade Chemistry recently announced construction of new facilities to triple manufacturing capacity for APIs for clinical trials and commercial production. The new facility is expected to be operational in 2022 and will add to the combined entity’s GMP capacity and scale.

Source: Aceto


Biologics Manufacturing

Samsung Biologics To Add mRNA Vaccine Drug-Substance Mfg
Samsung Biologics, an Incheon, South Korea-based contract biologics manufacturer, has announced plans to add mRNA vaccine drug-substance manufacturing at its current facility in Songdo, South Korea with the goal of having operations ready in early 2022.

The addition will enable Samsung Biologics to provide end-to-end mRNA vaccine manufacturing services from bulk drug substance to aseptic fill–finish, including labeling and packaging, as well as cold-chain storage.

Separately, the company has opened a new R&D Center in San Francisco, California. Construction is also ongoing for its fourth and largest biomanufacturing facility in Incheon, South Korea. Upon completion of the facility, Samsung Biologics will hold a total of 620,000 liters of cell-culture capacity

Source: Samsung Biologics


Lonza JV Bacthera Gets IK for Mfg Licenses for Live Biotherapeutics
Bacthera, a CDMO of live biotherapeutic products and a joint venture between Lonza and Chr. Hansen, has been granted manufacturing licenses for its drug-substance manufacturing facility in Hørsholm, Denmark and its drug-product manufacturing facility in Basel Switzerland, respectively by Swiss and Danish regulatory authorities.

The licenses mean Bacthera is ready to supply live biotherapeutic products, a new therapeutic class based on live microbes.

Source: Lonza


Avantor Acquires RIM Bio
Avantor, a supplier of ultra-high-purity materials for the life sciences and advanced technology industries, has acquired RIM Bio, a China-based manufacturer of single-use bioprocess bags and assemblies for biopharmaceutical manufacturing applications.

Established in 2009, RIM Bio provides a range of single-use 2D bags, 3D bags, tank liners, bag assemblies and multi-bag manifolds used biomanufacturing.  

RIM Bio's Changzhou, China, facility is Avantor's first single-use production plant in the Asia, Middle East and Africa (AMEA) region to build on the company's existing global single-use manufacturing network in the Americas and Europe.

This acquisition marks another major investment in China for Avantor. In December 2019, the company opened its Shanghai Innovation & Customer Support center, a bioprocessing facility focused on research, application development and process optimization for bio/pharma companies across AMEA.

Source: Avantor


Cytiva Acquires GoSilico for Digital Bioprocessing
Cytiva, the new name of GE Healthcare Life Sciences following Danaher’s $21.4-billion acquisition of GE Healthcare Life Sciences in April 2020, has acquired GoSilico, a Karlsruhe, Germany-based company that digitalizes biopharmaceutical downstream process development with computer simulation.

GoSilico’s simulation software is used to build digital twins of downstream processing and is used to enhance process development by simulation.

Source: Cytiva


Danaher Acquires Precision NanoSystems
Danaher Corporation has acquired Precision NanoSystems (PNI), a Vancouver, Canada-based company focused on technologies for nanomedicines. PNI also provides development and manufacturing of lipid nanoparticles for the delivery of genetic medicines, including mRNA. 

PNI will join Danaher’s Life Sciences platform and will be complementary to other businesses in the platform, including Cytiva and Pall. The acquisition of PNI and its 150 associates follows Cytiva’s recent acquisition of Vanrx Pharmasystems, a British Columbia, Canada-based company that makes robotic aseptic filling machines to fill vials, syringes, and cartridges.

PNI is developing a new center of manufacturing excellence in Vancouver, which will proceed as planned

Source: Pall Corporation


Exothera Appoints New CEO
Exothera, a Brussels, Belgium-based viral vector CDMO launched by Univercells, a technology company specializing in bioprocessing, has appointed Thibault Jonckheere as CEO of Exothera, effective June 1, 2021.

Mr. Jonckheere joined Exothera as Deputy Chief Executive Officer following the carve-out of the company from Univercells in April 2020. Mr. Jonckheere started his career in the energy sector, holding several financial and consultancy positions. He joined MaSTherCell, a CDMO specializing in development and manufacturing services for cell and gene therapies, in 2013 as Corporate and Business Development Manager. In 2016, Thibault joined ImmunXperts, an immunology CRO, where he developed the company until its sale to Nexelis, a CRO with operations in the US and Canada, at the beginning of 2020.

Source: Exothera


Formulation Development/Drug-Product Manufacturing

Vectura in Proposed $1.35-Bn Buyout from Carlyle Group
Vectura Group, a Chippenham, UK-based drug-delivery company, has accepted a £958-million ($1.35-billion) buyout offer from Murano Bidco Limited, a newly formed company for the purpose of the acquisition and indirectly controlled by funds managed by the Carlyle Group, an investment firm

Vectura is a provider of inhaled drug-delivery services. Vectura has 13 key inhaled and 11 non-inhaled products marketed by partners with global royalty streams and a partnered portfolio of drugs in clinical development.

The boards of Vectura and Bidco have agreed to the acquisition, and the board of Vectura plans to recommend shareholder approval. The deal is expected to close in the third quarter of 2021.

Source: Vectura


August Bioservices Closes $23.6-M Deal To Expand US Mfg
August Bioservices, a Nashville, Tennessee-headquartered CDMO (formerly PMI Biopharma Solutions), has raised $23.6 million to expand its manufacturing capacity for sterile injectables.

In November 2020, August announced a $64.7-million investment to expand its Nashville manufacturing operations. The first expansion project, which will focus on renovating August’s existing facility, includes the addition of development and manufacturing capabilities for liquid and lyophilized vials, prefilled syringes, IV bags, and terminal sterilization. This renovation is expected to be completed in late 2021. The second expansion project will add a new high-speed manufacturing facility, adjacent to the company’s existing building, which will create one contiguous campus for drug discovery, development, and manufacturing at the company's site in Nashville

August’s service portfolio includes cGMP non-sterile and bulk manufacturing, aseptic fill–finish, labeling and related services. The company also provides drug formulation, process design and scale-up, analytical and stability testing, and research services that feature target validation, characterization and assay development, protein engineering and cell-line development.

Source: August Bioservices


Recro Expands Capabilities for Clinical Trial Services 
Recro Pharma, a CDMO of oral solid drug products, has expanded its clinical trial services offerings to include clinical-scale sachet and blister packaging.

Additionally, Recro has established a relationship with an European Union (EU) Qualified Person (QP) for its clinical trial services offerings following a successful review process. The QP has audited the company’s facility and stated that Recro meets the relevant GMP manufacturing standards and requirements for clinical trial materials to be used in the EU. Based on this audit, the QP’s organization has agreed that it can represent Recro’s clients for release of materials in the EU. A qualified person declaration is required for bio/pharmaceutical companies seeking to conduct a clinical trial in Europe using a drug product manufactured in a non-EU country. Recro is based in Gainesville, Georgia.

Source: Recro Pharma


MedPharm To Invest $2.1 M To Expand UK Site
MedPharm, a Guildford, UK-headquartered CDMO for topical and transdermal products, has announced a £1.5-million ($2.1-million) investment for the refurbishment and expansion of its 15,000-square-foot campus in Surrey, UK that will increase its UK laboratory space by 35%. 

The expansion, for formulation development and testing, is scheduled to be completed during the fourth quarter of 2021,

Separately, MedPharm is opening a new location in Raleigh-Durham, North Carolina to expand its CDMO services in topical and transdermal delivery. This new site, located within a few miles of MedPharm’s current Center of Excellence for topical and transdermal development, will allow for the manufacture of clinical batches and commercial-scale products in the US.

Source: MedPharm


Packaging

Stevanato, Corning in Pact for Presterilized Glass Vials
Stevanato Group, a Padua, Italy-based provider of drug containment, drug delivery, and diagnostic products and services, and Corning, a material sciences company, have signed a licensing agreement to offer biopharmaceutical companies glass vials in pre-sterilized packaging.

A new product, Corning Valor RTU Vials with SG EZ-fill Technology, is a combination of Corning Valor Glass vial attributes with SG EZ-fill integration and packaging advantages from Stevanato Group.

Stevanato Group designed its SG EZ-fill secondary packaging to store glass containers in a tray or nest & tub configuration for efficient filling while minimizing glass-to-glass contact.

Source: Stevanato Group


Sharp Plans Expansion with Land Purchase
Sharp, a provider of contract packaging and clinical supply services, has purchased new land as part of a $17-million investment into its Conshohocken, Pennsylvania site.

The new four-acre plot is directly adjacent to Sharp’s two existing commercial pharmaceutical packaging buildings and is the latest addition to an ongoing capacity expansion project at the Conshohocken campus.

This land purchase will enable Sharp to add future capacity for cGMP packaging services and is part of a broader $43-million investment into its Pennsylvania operations, which includes increasing the company’s blister-packaging capacity by over 35% this year.

The Conshohocken investment to date (as reported on May 26, 2021) includes the construction and fit out of six new primary GMP rooms as well as fit out for secondary packaging and installation of new blister lines.

Source: Sharp


General

Cryoport Opens New Global Logistics Center in Singapore
Cryoport, a Brentwood, Tennessee-headquartered provider of cold-chain logistics services, reports that its wholly owned operating companies, Cryoport Systems and CRYOPDP, have jointly opened a new Global Logistics Center in Singapore.

The Singapore location follows the launch of Cryoport Systems' and CRYOPDP's first jointly operated Global Logistics Center in Osaka, Japan in the fourth quarter of 2020. As with all the company's existing Global Logistics Centers, the Singapore facility is outfitted to handle a temperature range from -196° Celsius and every single gradient, up to and including controlled-room temperature

Source: Cryoport


Premier Research Acquires Camargo Pharmaceutical Services
Premier Research, a provider of advisory services and clinical development services to the biotechnology, specialty pharma, and medical device industries, has acquired Camargo Pharmaceutical Services, a Cincinnati, Ohio-based drug-development consultancy.

Source: Premier Research