CUSTOM SERVICES
Manufacturing services support pharma development
Fine chemical and biomanufacturing companies are benefitting from pharmaceutical companies continuing to modify their business models by increasingly outsourcing their R&D and manufacturing functions, particularly for the synthesis or biomanufacture of advanced chemical intermediates, APIs and biopharmaceuticals. We report on recent collaborations and new service offerings in these sectors.
Cambrex Corporation recently entered into an agreement to supply an active pharmaceutical ingredient for a customer’s Phase 3 programme during 2013 and 2014. Under this non-exclusive supply arrangement, Cambrex will manufacture and deliver Phase 3 and pre- launch quantities of this product candidate. The agreement is expected to contribute more than $20 million to the company’s 2013 revenues and potentially more in 2014 depending on regulatory developments, the timing of completion of Cambrex’s capacity expansion related to this activity, and meeting key product delivery milestones. The agreement does not affect sales or profits in 2012 and does not include any commitments beyond 2014.
In order to meet the demand under the new agreement, Cambrex will make significant investments over the remainder of 2012 and in early 2013 to expand its multi-purpose large-scale cGMP assets. Consequently, the company is revising its previously announced guidance for 2012 capital expenditures, which are now expected to be between $33 million and $36 million in 2012 compared to prior guidance of $16 million to $19 million. Capital expenditures related to the expansion, which includes investment in manufacturing capacity to support other growth initiatives, are expected to total about $19 million.
Specialist purification services alliance
UK-based chemistry services company Onyx Scientific has established a collaboration with a purification specialist that will see the company broaden its offering to the global pharmaceutical and biotech industry. The company has formed a strategic alliance with Reach Separations, which will allow it to deliver more specialist purification and separation services as part of its early-stage development services. Onyx Scientific is now able to offer custom separation for companies working in drug discovery and the fine
26 sp2 Inter-Active September/October 2012
chemical intermediate sectors. Technologies available include chiral, reverse phase and normal phase chromatography using supercritical fluid chromatography (SFC) and high performance liquid chromatography (HPLC). With MHRA and FDA licensed facilities in the UK and India, Onyx Scientific supports pharmaceutical and biotech companies from medicinal chemistry and preclinical
development through to Phase 1-3 clinical development, scaling up to large-scale commercial API production.
“Cambrex will make
significant investments over the remainder of 2012 and in early 2013 to expand its multi-purpose
Reach Separations is located in BioCity in Nottingham, UK, one of the largest bioscience incubators in Europe. There are more than 70 companies based at BioCity, which has a strong history in drug discovery. Onyx Scientific has worked as a preferred partner for a large number of international pharmaceutical companies, and provides complex chemical services and early-stage programmes based on custom synthesis, lead optimisation, chemical process development, solid-state chemistry and GMP synthesis. The company is then able to scale up, internally tech transfer and provide increased manufacturing efficiency from its commercial manufacturing sites in India.
Protein expression technology licensing agreement
CEVEC Pharmaceuticals, the developer of a novel human protein expression system derived from amniocytes, and Paragon Bioservices, Inc, a contract research and GMP manufacturing organisation focused on the development and manufacture of biopharmaceuticals, have established a
large-scale cGMP assets”
collaboration in which Paragon Bioservices has licensed and used CEVEC’s CAP and CAP-T cell expression system technology to develop stable cell lines and perform process development for the contract manufacturing of recombinant proteins and antibodies. Paragon is a contract research and GMP manufacturing organisation providing research, development and manufacturing services with a focus on biopharmaceuticals, including recombinant proteins, viral vectors, vaccines, VLPs,
bacteriophage and stem cells. The company has extensive experience in cell biology and
bioprocess development, but said that it was
licensing CEVEC’s technology to meet the outsourcing requirements of the biopharmaceutical sector. The company said the technology would assist it in offering a fully optimised human expression system that will express proteins with superior yields and in a shorter timeframe than traditional methods.
Located in Cologne, Germany, CEVEC Pharmaceuticals GmbH has been operational since 2004 and is a biopharmaceutical company that specialises in developing and producing therapeutic proteins, vaccines and monoclonal antibodies with human glycosylation patterns.
The company’s novel proprietary and patent-protected human CAP and CAP-T T expression systems are designed for the manufacture of complex biopharmaceutical molecules and various vaccines. The company has a strategy of licensing out its human cell-based expression platform as well as its own biobetter candidates through partnerships with pharmaceutical and biotech companies.
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