March 12, 2018 PAP-Q1-18-CL-015
Chemo is part of the Spanish multinational, Insud Pharma, a large, diversified pharmaceutical company with an entrepreneurial spirit and commitment to continued investment in infrastructure and expertise to support its ever-widening activities. Chemo CMO is the latest division to be added to the group.
Chemo produces over 100 molecules (steroids, hormones, prostaglandins, prazols and antibiotics) and 50 formulated products in a variety of dosage forms (tablets, capsules, granules, inhalers, topicals, injectables and suspensions) covering all major therapeutic areas. Chemo also manufactures OTC and animal health products.
Our comprehensive integrated quality and safety management system ensures manufacturing in accordance with cGMP requirements and international pharma-ceutical industry standards across our entire manufacturing network, which com-prises eight state-of-the-art manufacturing facilities and eight R&D centers that are inspected regularly by FDA, EMA and local regulatory authorities.
Innovation and technology is the driving force of our business and is the backbone of our operations. We regularly invest in R&D to develop complex dosage forms, optimize manufacturing processes, and ensure a dynamic and useful portfolio of capabilities. Chemo’s strong commitment to continual growth is reflected by the recent construction of two new manufacturing facilities in León, Spain dedicated to sterile hormonal products and in Madrid for sterile injectable manufacturing using state-of-the-art technology and the highest quality standards.
Chemo CMO’s manufacturing expertise and flexible capacity provide a fast path to client drug approvals, making us the preferred CMO partner across all major dosage forms.
The newest dosage form for Chemo CMO is sterile injectables. There is growing demand for these products, but quality and capacity remain significant issues. Drug developers looking for CMO partners with sterile injectable capabilities are, for that reason, willing to look outside North America for manufacturing partners with state-of-the-art facilities and the assurance of high reliability and quality.
Chemo Industrial CMO is one of those partners. Our Universal Farma (Madrid area) and Farmalan (León) sites are new production facilities focused on sterile injectable manufacturing, with the Farmalan facility dedicated to hormonal products. Aqueous solutions, oily formulations, suspensions and lyophilized products can be produced at these plants in single- and multi-dose vials and prefilled syringes. Aseptic filling and freeze-drying services are provided at both facilities. Universal Farma also has capabilities in terminal sterilization, and unique and much-needed capability for API sterilization.
API sterilization is, in fact, a unique capability, and particularly important for products formulated as suspensions. This capability is offered both to clients that come to Chemo CMO with fill/finish projects that require sterile APIs and as a standalone service. API sterilization is obtained using aseptic filtration, with two possibilities — either micronization for particle size reduction or bead milling to create suspension dispersion. This area is segregated from the rest of the plant and serviced by a dedicated CIP/SIP system.
The new facilities are state-of-the-art and designed to be flexible. They were constructed so that the unique requirements of each sterile injectable manufacturing project can be accommodated. Vial and syringe filling line work under grade A (in RABS), and grade B and grade C formulation and filling areas are present at both sites.
As a dynamic company with a truly entrepreneurial spirit, yet with long-standing expertise in pharmaceutical development and manufacturing, we are eager to expand into new activities and have much to offer our customers. Clients can benefit from co-development opportunities and the greater freedom for creativity at Chemo CMO.
Masha Kononov, MS has over twenty years of diverse experience in pharmaceutical development, biotech and pharma services industries. Her career within the pharmaceutical services industry, which spans almost ten years, has allowed her to build the in-depth knowledge of the drug product development and pharmaceutical manufacturing. Masha plays a pivotal role of Chemo’s team charged with meeting the company’s ambitious growth targets for its CMO business.