The latest news from CDMOs, CMOs, and suppliers featuring news from Thermo Fisher, Cambrex, Lonza, Vetter, Sterling Pharma, Fujifilm, PCI Pharma Services, Particle Sciences, Vibologics, iBio, and Parexel.

Chemicals/Chemical API Manufacturing

Cambrex Completes New Process and Analytical Development Facility and Logistics Center

Cambrex, a contract manufacturer of small-molecule active pharmaceutical ingredients and drug products, has completed a new 600-square-meter facility at its site in Karlskoga, Sweden, including new laboratories for process and analytical development and a $6-million, 3,000-square-meter logistics center.

The new building will incorporate process technology, quality control and analytical development laboratories. The process technology laboratories will expand capacity providing an area where R&D and production teams can work on scale-up demonstration and technology transfer, including new capabilities in the scaling up of potent molecules requiring containment.  The facility will employ computer modeling to optimize reactor set-ups and plant conditions to improve technology transfer and the performance of existing processes.

The new laboratories include high-pressure reaction vessels and crystallization equipment for drug-substance manufacturing, with vessels that can handle conditions from cryogenic to nearly 200 degrees Celsius. The logistics center will include a cGMP-compliant warehouse with temperature monitoring and control, with the capacity for 4,500 pallets.

Cambrex’s site in Karlskoga currently employs over 400 people with a wide range of manufacturing facilities, including four cGMP pilot plants and seven full-scale commercial production units.

Source: Cambrex

Sterling Pharma’s $7.6-Million API Pilot Plant is Now Operational

Sterling Pharma Solutions, a Dudley, UK-headquartered contract provider of small-molecule active pharmaceutical ingredient (API) development and manufacturing services, has announced that its pilot-plant facility is now operational at its UK site following a £6-million ($7.6-million) investment last year.

The new cGMP facility will increase the existing pilot plant’s capacity by 33%. The expansion included three new reactor trains at scales of 225 L, 500 L and 1,360 L and enables small to mid-scale clinical supply and commercial batch production. The investment allows the company to handle potent compounds across a range of equipment scales to complement the company’s existing offering.

Source: Sterling Pharma Solutions

Biologics Manufacturing

Thermo Fisher in Collaboration With Scinogy For Gene-Therapy Mfg

Thermo Fisher Scientific has entered into a collaboration with Scinogy, a provider of automated manufacturing systems for cell therapies, to develop and commercialize instrumentation and reagent systems for gene-therapy manufacturing.

This collaboration will provide closed, modular, automated systems designed for scalable cell- and gene- therapy development and manufacturing.

As a result of the collaboration, Thermo Fisher will introduce the new Gibco CTS Rotea Counterflow Centrifugation System, a reproducible, closed cell-processing system designed for separation, washing and concentration of autologous and small-scale allogeneic cell-therapy samples.

Source: Thermo Fisher Scientific

Private Equity Firm Ampersand To Acquire CDMO Vibologics

Ampersand Capital Partners, a private-equity firm in the healthcare sector, has agreed to acquire Vibologics, a contract development and manufacturing organization (CDMO) of viral therapies, gene therapies, and vaccines.

Vibologics works with biopharmaceutical companies to develop, manufacture and fill–finish products involved in the development of oncolytic viral therapies, gene therapies, and vaccines. The company focus on viruses, live bacteria, and aseptic processing. It has a 27,000-square-foot facility in Cuxhaven, Germany and currently employs 50 staff members.

Source: Vibologics

Fujifilm Opens Life Science Office in Massachusetts

Fujifilm Holdings America Corporation is opening a new Life Science Strategic Business Office in Cambridge, Massachusetts to increase its presence in relation to pharmaceutical and biotechnology businesses in the surrounding area.

In its life-science business, Fujifilm is focused on cell and gene therapeutics, biopharmaceutical contract development and manufacturing, cell-culture media and reagents, research-use tools and instruments, in-vitro diagnostics, drug-discovery and drug-delivery solutions.

Fujifilm Corporation’s Life Science Strategic Business Office also has collaborations for translational medical research with Harvard Medical School, the Massachusetts Institute of Technology and Lyndra Therapeutics.

Source: Fujifilm

Formulation Development/ Drug Product Manufacturing

CDMO iBio Introduces Sterile Fill–Finish Services

iBio Inc., a plant-based biopharmaceutical contract development and manufacturing organization (CDMO), has launched new sterile cGMP fill–finish services for pharmaceutical products, including monoclonal antibodies, viral vectors, and other biologics. The operation is located at the company’s 135,000-square-foot facility in Bryan, Texas.

These services are designed for clients with preclinical and clinical-stage programs. The liquid fill–finish operations will include in-line labeling and serialization of vials as they are filled. In the beginning, capacity will support 100 to 2,500 vials runs, expecting to expand to 15,000.

Source: iBio

Particle Sciences Gains DEA Schedule I Authorization for Controlled Substances

Particle Sciences, a Lubrizol LifeSciences company and pharmaceutical contract development and manufacturing organization, has broadened its Drug Enforcement Administration (DEA) registration to become an authorized manufacturer of Schedule I substances.

The expanded DEA registration was granted to allow Particle Sciences to carry out analytical testing, development and manufacturing of cannabis-derived materials for pharmaceutical applications in the United States.

Particle Sciences currently develops and manufactures Schedule II–V controlled drug products at its facility in Bethlehem, Pennsylvania, working on products ranging from nasal delivery systems for diazepam to long-acting buprenorphine dosage forms.

Source: Particle Sciences

Packaging

PCI Pharma Services To Expand with Third Clinical Trials Storage Site in San Diego

PCI Pharma Services, a provider of pharmaceutical packaging solutions and a contract development and manufacturing organization of drug products, has expanded its West Coast clinical operations with a third facility in San Diego, California.

The new 38,000-square-foot facility will serve as the main storage, logistics and distribution center on the West Coast. The building will be equipped with controlled-room temperature, cold-chain requirements for 2-8 degrees Celsius, -20° degrees Celsius, and -80 degrees Celsius with ultra-low freezer capabilities and cryogenic liquid nitrogen storage at -196 degrees Celsius.

The San Diego site is one of the company’s eight global clinical locations across the US, Europe and Asia Pacific regions, working in clinical trials in more than 100 countries. The expansion will be completed and validated during the fourth quarter of 2019.

Source: PCI Pharma Services

General

Lonza To Carve Out Its Specialty Ingredients Segment

Lonza Group is carving out its Specialty Ingredients segment (LSI), which consists of products for microbial control. It will operate independently but still remain a fully owned segment of Lonza Group. Lonza has already started the separation and expects to complete the process by mid-year 2020.

The LSI business will be run by independent management, focused on operations and costs leading to around 130 roles being placed under consultation for redundancy, 50 in Switzerland and 35 in the US. This program is limited to the LSI segment and the support functions and does not impact the Pharma Biotech & Nutrition segment.

Source: Lonza

Parexel To Invest $1.7 Million in Second US Headquarters

Parexel International Corporation, a contract research organization, is opening its second US headquarters in Durham, North Carolina, providing 264 jobs. Parexel will invest $1.7 million in the facility.

Parexel currently employs more than 600 staff members in North Carolina. Parexel is a wholly owned subsidiary of United Kingdom-based West Street Holdings III Limited, with around 20,000 employees globally. The company provides biopharmaceutical research and services from clinic trials to regulatory and consulting services to commercial and market access.

Parexel’s expansion will be partially facilitated by a Job Development Investment Grant (JDIG), where over the course of a set 12-year term the project is expected to grow the state’s economy by $869 million. The JDIG agreement authorizes the potential reimbursement to the company of up to $4.2 million, spread over 12 years, following performance verification by the Departments of Commerce and Revenue.

The JDIG agreement calls for moving as much as $1.4 million into North Carolina’s Industrial Development Fund- Utility Account for economically challenged communities elsewhere in the state.

Source: Parexel

Vetter Sites Switch To Green Electricity

Vetter, a contract development and manufacturing organization of aseptically prefilled syringe systems, cartridges and vials, will be immediately begin switching to green electricity. All Vetter’s German sites will be supplied with only carbon dioxide neutral energy from certified renewable energy sources.

Within the next 10 years, Vetter plans to offset the company-wide use of natural gas, making it completely carbon dioxide neutral. Unavoidable emissions will be offset by investments in climate-protection projects.

Its largest sustainable-energy project implemented to date is its visual inspection and logistics center, which includes an environmentally friendly block heating and power plant, geothermal energy, use of excess energy and photovoltaic systems, combined for energy efficiency.

Source: Vetter