AGC Biologics, Thermo Fisher Expand; Recipharm Divests Bioanalysis BusinessBy
The latest news from CDMOs, CMOs, and suppliers featuring news from AGC Biologics, Thermo Fisher Scientific, Recipharm, Aptar, West, Schott, and Heraeus.
Chemicals/Chemical API Manufacturing
China’s Raybow Acquires US-Based API Manufacturer PharmAgra Labs
Raybow Pharmaceutical, a pharmaceutical chemistry services provider based in Taizhou, China, has acquired US-based PharmAgra Labs, a contract provider of custom synthesis, process development and analytical services.
Raybow is planning an expansion project at PharmAgra, which is based in Brevard, North Carolina, to add additional capacity and personnel in the Brevard area. The Brevard site will become the headquarters and research and development center for Raybow’s North American operations. It will be supported by sales and marketing offices in Los Angeles, California, Princeton, New Jersey, and Copenhagen, Denmark.
Raybow was founded in 2008 to provide process development and manufacturing services for biotech and large pharma clients. The company manufactures advanced intermediates, regulatory starting materials and APIs, including for high-potency products, at its FDA-inspected site in Taizhou, China.
Heraeus Pharma Expands High-Potency API Capacity
Heraeus Pharmaceutical Ingredients is expanding its production capacities for platinum-based highly potent active pharmaceutical ingredients. The company says the expansion is a response to increasing global demands for these products in cancer treatment.
Construction of the new multi-million-euro product line has already begun at the company’s headquarters in Hanau, Germany.
Source: Haraeus Pharma
AGC Biologics To Invest $18 Million To Expand Biomanufacturing Capacity
AGC Biologics, a contract provider of clinical and commercial manufacturing services for therapeutic proteins, plans to invest $18 million in its development and manufacturing capabilities at its Seattle, Washington and Copenhagen, Denmark facilities.
These facility upgrades, which are expected to begin in the second and third quarters of 2020, will eliminate bottlenecking and allow for capacity expansion. The Seattle investment will strengthen service from the clinical thru commercial phases and includes a 500-liter mammalian-cell bioreactor. The Copenhagen investment will enable the site to increase capacity and includes a new purification line.
Thermo Fisher To Invest $24 Million In Bioproduction Capabilities
Thermo Fisher Scientific is investing nearly $24 million in its site Inchinnan, Scotland to expand global bioproduction capabilities with additional large-volume liquid manufacturing capacity for cell-culture media.
Thermo Fisher’s liquid products, including cell-culture media, supplements, process liquids, water and buffers, are used throughout the upstream and downstream bioprocessing workflow.
The Inchinnan site expansion is expected to be completed by June 2021.
Source: Thermo Fisher Scientific
Formulation Development/Drug Product Manufacturing
ANI Pharmaceuticals Launches New Brand for CDMO Business
ANI Pharmaceuticals has launched its new CDMO brand, ANI Global Source. ANI Global Source is a specialty CDMO supporting late-stage development and commercial manufacture of pharmaceutical products, including tablets and capsules, liquid solutions, suspensions, topical liquids, creams and gels with expertise in hormones, potent compounds, and controlled substances.
ANI Global Source’s infrastructure includes over 300 employees and 270,000 square feet of manufacturing and packaging facilities across multiple sites.
The launch follows the integration of WellSpring Pharma Services, a CDMO of over-the counter and personal care brands in the US and Canada, which ANI Pharmaceuticals acquired in 2018.
Source: ANI Pharmaceuticals
Aptar CSP Launches Active Packaging Solution, Xcelerate
Aptar CSP Technologies, part of the Aptar Group and specializing in active packaging and material science, has launched Xcelerate, a complete solution service offering focusing on de-risking development and speed-to-market.
Xcelerate combines Aptar CSP’s material science and active packaging solution and associated services with FreeThink Technologies’ accelerated predictive modeling in shelf-life determination. Using FreeThink’s ASAPprime technology, an optimized active packaging solution product is modeled and tested without the need for line trials. The result eliminates repetitive design processes and reformulations caused by stability test failures, according to information from the company.
Xcelerate includes capabilities to produce clinical trial and stability samples, regulatory support, consulting and testing during commercial implementation. Xcelerate’ s process determines a drug product’s moisture and oxygen sensitivity using accelerated stability studies open to specific environmental conditions, such as temperature, relative humidity and oxygen level, then uses modeling to create theoretical packaging designs. Once the optimal packaging sorbent levels are determined, laboratory, clinical and stability study sample supplies can be prepared for confirmation or actual use.
Aptar CSP has its proprietary three-phase Activ-Polymer technology platform, delivered in a variety of configurations such as : Activ-Blister solutions, which control the internal atmosphere of individual blister cavities, Activ-Seal closures, which incorporate moisture and gas-scavenging technology, the Activ-Vial portfolio, which consists of one-piece, flip-top desiccated vials and bottles, and Activ-Film, which was developed to enhance transdermal drug delivery systems.
Source: Aptar CSP Technologies
West Pharmaceutical Services, Schott Partner for Packaging Platforms
West Pharmaceutical Services, a provider of solutions for injectable drug administration, and the primary packaging solutions provider, Schott, have partnered to combine the Schott iQ platform with West’s Ready Pack system.
West’s Ready Pack system consists of sterilized NovaPure stoppers, Flip-Off CCS seals and Schott’s adaptiQ vials. The combination of West and Schott products will serve research and development or small filling operations. The Read Pack system is also scalable, designed to support a transition from early-stage pilot manufacture to large commercial-scale operations.
Schott’s adaptiQ vials will be available in various formats with different sterile packaging options such as the clip nest, cup nest, and tray solution and can be processed on a wide range of existing and new fill and finish equipment. Nested processing ensures no glass-to-glass contact of the vials throughout the fill–finish process including lyophilization.
West says the collaboration will initially launch by combining West components and Schott’s adaptiQ high-quality ready-to-use glass vials and will expand to include other ready-to-use combinations of West and Schott’s products, to be available on a small-quantity basis.
The companies made the announcement earlier this month (November 2019) and shared plans to expand West’s Ready Pack system to include additional Schott’s glass offerings, including more vial formats as well as ready-to-use cartridges (cartriQ) and pre-fillable glass syringes (syriQ). Further product launch plans will be shared in early 2020.
Source : West Pharmaceutical Services
Barentz Acquires Majority Share in European IMCoPharma
Barentz, a distributor of ingredients in life-science markets, has acquired a majority shareholding in Czech Republic-based IMCoPharma, a full-service pharmaceutical company.
IMCoPharma researches, markets and distributes a portfolio of products and services, such as contract manufacturing, licensing and transfer of pharmaceutical technology in the Commonwealth of Independent States (CIS) region and Ukraine. The active pharmaceutical ingredients, excipients and final dosage forms are manufactured by European pharmaceutical manufacturers.
This strategic investment provides Barentz with the licensing capability to do business with all pharmaceutical companies in this region. Earlier this month (November 2019), the founder and CEO of IMCoPharma, Ivan Mikes and CEO of Barentz, Hidde van der Wal, signed a term sheet to formally start the process of Barentz’ acquisition.
Source: Barentz, IMCoPharma
Recipharm Divests Bioanalysis Business to Center for Translational Research
Recipharm, a CDMO for clinical trial materials and APIs, is divesting its GLP bioanalysis business to the Center for Translation Research (CTR), the Uppsala-based parent company of CTC Clinical Trial Consultants.
Recipharm says the GLP bioanalysis laboratory will now continue its assignments as a newly formed company, Lablytica Life Science AB, 100% owned by CTR.
Recipharm and CTC Clinical Trial Consultants partnered in 2017 to form Recipharm Pathway to Clinic, a provider of Phase I clinical trial requirements. Recipharm performs formulation development and GMP clinical supply manufacture while CTC Clinical Trial Consultants is responsible for early-phase clinical trials (Phase 0 to IIa).
Recipharm says the analytical activities will continue without interruption with the same staff, in the same facilities, using the same instrumentation and validated analytical methods, with David Pekar, Head of Bioanalysis.
Source: Recipharm, CTC Clinical Trial Consultants
Thermo Fisher Scientific Opens Customer Solution Center in Shanghai
Thermo Fisher Scientific has opened a Customer Solution Center in Shanghai, China. This follows the recent announcements of a Biosciences Customer Exploration Center in Shanghai and the expansion of its clinical trials logistics facility in Suzhou.
The new Pharma and BioPharma Center will provide expertise in critical analytical processes and specialized workflows.
Source: Thermo Fisher Scientific