NextPharma To Acquire Two Lonza Sites; Cognate, LSNE To ExpandBy
The latest from CDMOs, CMOs, and suppliers featuring Lonza, NextPharma, LSNE Contract Manufacturing, Leukocare, Cognate BioServices, and CoreRx.
Cognate BioServices To Expand Cell and Gene Therapy Mfg Facilities
Cognate BioServices, a CDMO specializing in cell and cell-mediated gene-therapy products, has announced plans to expand cell and gene-therapy manufacturing capacity, laboratory space, and warehousing and increase office support at its facilities in the US and Europe.
The expansion will nearly double capacity at Cognate’s existing manufacturing facility and headquarters site in Memphis, Tennessee. In Memphis, the company plans to add two separate facilities: a distribution center and a third facility focused on commercial manufacturing, all totaling nearly 250,000 square feet of space. Construction has already begun on the distribution center and is expected to be finalized in early 2021. Build-out of the commercial manufacturing facility will begin in 2021 with the goal of coming on line as soon as possible (as reported in January 2021).
Cognate initially outlined these US expansion plans in connection with its application for a 15-year Expansion PILOT (payment-in-lieu-of-taxes) approval from the Economic Development Growth Engine (EDGE) for Memphis and Shelby County, Tennessee.
In addition, Cobra Biologics, the gene therapy division of the Cognate BioServices’ is undertaking a multi-phase expansion of plasmid DNA capacity. This includes a four-fold increase in HQ (high quality) DNA manufacturing capacity and new clinical and commercial DNA facilities at its European facilities. The HQ plasmid manufacturing service provides a six-week delivery time for the clinical manufacture of immuno-oncology therapies.
Cognate acquired Cobra Biologics, a biologics CDMO that provides development and manufacturing services for plasmid DNA and viral vectors, proteins and microbiota as well as fill–finish services, in 2019.
Source: Cognate BioServices
Formulation Development/Drug-Product Manufacturing
NextPharma To Acquire Two Lonza LipidDosage Forms Sites
NextPharma, a London-headquartered CDMO that specializes in oral and topical finished dosage forms, has agreed to acquire Lonza’s sites in Ploermel, France and Edinburgh, UK that specialize in lipid oral dosage forms.
The Ploermel and Edinburgh sites produce liquid-filled hard capsules and softgels (including for high potent and hormonal products) for the pharmaceutical and consumer health and nutrition markets.
With this pending divestment, Lonza plans to exit both softgels and liquid-filled hard capsules for the pharma market, but will retain capability for feasibility studies as part of a technology selection offering. In the consumer health and nutrition space, Lonza plans to exit softgels but continue to offer Licaps-based products (lipid capsules) out of its facilities in Colmar, France, Greenwood, South Carolina, and Sagamihara, Japan.
Separately, Lonza recently announced an investment of CHF 85 million ($94 million) to expand capsule manufacturing capacity by 30 billion capsules annually across eight sites.
NextPharma provides CDMO services for oral and topical (including sterile ophthalmic) finished dosage forms. With this pending acquisition, NextPharma plans to develop and broaden its technology offering into lipid-based finished dosage forms (softgels and liquid-filled hard capsules).
The agreement is subject to relevant conditions and regulatory approvals, and where applicable, both parties will consult with local works councils
Source: Lonza and NextPharma
LSNE Expands Vial Fill-Finish, Lyophilization Operations
LSNE Contract Manufacturing, a CDMO of fill–finish and lyophilization services, has expanded its vial-filling and lyophilization capacity with the addition of a new automated aseptic fill line.
The new aseptic fill line will be housed in an existing ISO-5 cleanroom suite at its facility in Bedford, New Hampshire.
Source: LSNE Contract Manufacturing
Leukocare Begins US Operations
Leukocare AG, a Martinsried/Munich, Germany-based company specializing in formulation development for biologics, viral vectors, and vaccines, has announced the beginning of operations in the US, with the opening of its development laboratories and offices in Milford, Massachusetts. The US operations will also include an in-house biostatistics team.
The offices and laboratories are located at the Milford premises of Rentschler Biopharma, a CDMO for biopharmaceuticals. Leukocare and Rentschler Biopharma have had a strategic alliance since 2017.
Private Equity Firm Agrees to Acquire CoreRx
NovaQuest Private Equity, a Raleigh, North Carolina-based investment firm, has agreed to acquire CoreRx, a Clearwater, Florida-based CDMO of solid, liquid, and semi-solid dosage forms.
CoreRx offers preformulation, formulation, analytical and stability, clinical manufacturing, commercial manufacturing, and packaging services.
Affiliates of Signet Healthcare Partners, an investor in CoreRx since 2015, will retain a minority position.
Source: NovaQuest Private Equity