A&C, Comar Expand; MilliporeSigma in Excipient Pact
The latest news from CDMOs, CMOs, and suppliers featuring MilliporeSigma, A&C, Comar, Velesco, and ACG Inspection.
A&C Expands with New Bio Buffer Facility in Ireland
A&C, a manufacturer of excipients, buffers, process solutions,and a select number of active pharmaceutical ingredients (APIs) and headquartered in North America, has recently expanded its footprint into Europe with the opening of A&C Bio Buffer Ltd, a new GMP manufacturing facility in Ireland.
The Irish facility is ISO 9001:2015 certified and is dedicated to GMP manufacturing of biological buffers, process solutions, cleaning solutions, chemical blends, WFI (water for injection) and GMP raw material repacking.
The new Irish production site is another addition to the A&C Group, which currently has two GMP manufacturing plants in North America. A&C holds all the major quality certifications and applicable licenses from the main accreditation bodies, including ISO 9001:2015, EXCiPACT, DEL for the manufacture of APIs, and is Health Canada- and FDA-audited.
Formulation Development/Drug Product Manufacturing
ReForm Biologics, MilliporeSigma in Excipients Pact
ReForm Biologics, a pharmaceutical technology company for biologic formulations, and MilliporeSigma, have formed a global license and collaboration to commercialize proprietary ReForm excipients used in biotherapeutic formulations.
Under the agreement, MilliporeSigma and ReForm Biologics will conduct research, development and qualification of ReForm Biologics’ excipients for pharmaceutical use. MilliporeSigma will fund the research and development and be responsible for global commercialization, GMP manufacturing, and sale of ReForm Biologics’ excipients to MilliporeSigma’s customers for use in biologic formulations. ReForm Biologics will receive revenues from MilliporeSigma for sublicensing ReForm Biologics’ technology to MilliporeSigma’s customers in biologic formulations.
The Life Science business of Merck KGaA operates as MilliporeSigma in the US and Canada.
Source: ReForm Biologics
Velesco Pharma Begins Operations at New Clinical Mfg Facility
Velesco Pharma, a provider of early- and late-stage drug-development services, has begun operations at its new cGMP clinical manufacturing facility in Wixom, Michigan. This facility will operate in coordination with Velesco Pharma’s existing Wixom site, which houses its pharmaceutical research and development laboratories that provide formulation development, analytical method development, and testing services. The new facility replaces and consolidates the company’s existing manufacturing site in Kalamazoo, Michigan.
The facility is set to triple the company’s cGMP clinical trial manufacturing capacity and features expanded processing suite space to manufacture a range of non-sterile dosage forms, including liquids, semi-solids, powders, capsules, and tablets. The facility will have the capability to handle high-potency compounds..
Source: Velesco Pharma
ACG Inspection Introduces Blockchain-based Platform for Pharma Supply Chain
ACG Inspection, one of the four business of ACG Group and a supplier of end-to-end manufacturing solutions for the pharmaceutical industry, has a new blockchain-based solution, Brand Security Platform, to meet traceability and anti-counterfeiting requirements in the pharmaceutical supply chain.
The company’s Brand Security Platform combines GS1 2D Data Matrix, smart contracts, geolocation identification, and product biometrics tracking to ensure the whereabouts and contents of packaged medicines are closely monitored through their entire supply-chain process from manufacturer to end user. The new system will include distributed ledger technology and single ownership. It is designed to avoid establishing single-owner data sets and digitally broken supply chains.
The solution has three primary components consisting of blockchain, Internet of things (IoT) and artificial intelligence (AI). Each of these can be incorporated individually or bundled. They are scalable and can provide basic data management to full-scale, supply chain-wide transparency.
ACG offers products in capsules, films and foils, engineering, and inspection systems.
Source: ACG Inspection
Comar To Expand with New Injection Molding Facilty
Comar, a specialty packaging, device and component supplier, is building a new facility in Rancho Cucamonga, California dedicated to injection blow molding, injection stretch blow molding and injection molding cells.
The new 230,000-square-foot facility will be ISO 13485 certified, cGMP compliant, and US Food and Drug Administration registered, and 26,000 square feet of the facility will have ISO Class 8 injection molding and assembly cleanrooms with room for expansion. The new facility will feature a full-service mold prototyping lab and dedicated mold sampling and development equipment.
Comar has submitted drawings and permit applications with a goal of beginning construction in the spring of 2020 and to complete move-in and production start-up of the new facility by the end of 2020. The facility will support manufacturing of complex finished medical devices and sub-assemblies incorporating injection molding, blow molding, high-speed assembly, testing, and finished-device pack-out.
Comar has eight strategic manufacturing and distribution locations and uses rigid plastic packaging technologies, including injection molding, injection blow molding, injection stretch blow molding, and extrusion blow molding.