Contract Manufacturers and Fine-Chemicals Producers Expand

Contract manufacturers and fine-chemical producers used CPhI Worldwide, held in Madrid, Oct. 9–13, to highlight recent manufacturing capacity and services partnerships and related partnerships. Some highlights from the show and recent news subsequent to the show are outlined below.

Aesica won the European Outsourcing award for “best acquisition” following its acquisition and integration of three different UCB sites at Monheim and Zwickau in Germany, and Pianezza in Italy in 2011. The acquisition of the UCB sites follows the integration of R5 Pharmaceuticals in 2010. The acquisitions contributed to revenue gains for the company, with sales growing more than 37% in the past two years, and revenues predicted to grow from $180 million in 2011 to $270 million by the end of the yea, according to the company.

Almac is expanding its API manufacturing facility at its European Headquarters in Craigavon, United Kingdom. The expansion is near completion and will be operational by the end of the year. This upgrade includes installation of two 1000-L reactors and a pressure-filter dryer, which allows production of GMP APIs up to 150-kg batch.

In other news, Almac and DSM in biocatalysis. The agreement grants both parties access to their enzyme platform technologies, services, and expertise for the manufacturing of APIs.

AMRI entered into an agreement with Knopp Biosciences to provide various discovery-related services that include medicinal chemistry, drug metabolism and pharmacokinetics, and computer-aided drug discovery, as part of AMRI’s Smartsourcing platform. In other news, AMRI has entered into a multiyear supply agreement for an undisclosed product with Shire US Manufacturing. The agreement extends a previously existing agreement between the two companies.

Aptuit has announced the offering of antibacterial studies from a single site, the Aptuit Center for Drug Discovery and Development in Verona, Italy.

Cambridge Major Laboratories (CML) is planning an expansion of its large-scale API manufacturing facility in Germantown, Wisconsin. The expansion comes three years after commissioning the new site. The expansion will include additional reactor capacity as well as isolation equipment. Alongside capacity additions, CML has made additional investments in engineering controls to ensure the sustainability of the business.

Carbogen Amcis and ADC Biotechnology have agreed to provide customers with development and manufacturing services for antibody drug conjugates. ADC is developing a “lock and release” solid-phase immobilization technology for production of ADCs. The alliance will offer services for the development, scale-up, manufacturing, and formulation of protein-based drug conjugates. ADC Bio will provide access to proprietary solid-phase immobilization technologies for conjugation and long-term storage of ADCs, and Carbogen Amcis will focus on focus on small- to large-scale GMP supply and on the formulation of ADCs.

Cambrex has agreed to supply an API for a customer’s Phase III program. The agreement is expected to contribute more than $20 million in revenues to Cambrex, which will expand its large-scale multipurpose cGMP assets in 2012 and 2013.

Catalent Pharma Solutions has launched the Catalent Applied Drug Delivery Institute to promote innovation, knowledge-sharing, and collaboration between industry leaders, academic experts, customers and regulators to enhance understanding of available, emerging, and future drug-delivery technologies and improve patient care. As part of its mission, the Catalent Applied Drug Delivery Institute will serve as a link between industry and academia by providing guidance, counsel, and resources on major issues pertaining to drug development, delivery, and formulation. The Institute will develop programs that facilitate mutually beneficial collaborations, increase communication, and shed light on regulatory issues affecting drug developers and researchers. It also will pursue a multitiered approach of seed funding, strategic counsel, and educational programs to advance the adoption of emerging technologies. Catalent announced the launch of the institute at the 2012 American Association of Pharmaceutical Scientists (AAPS) Annual Meeting and Exposition in Chicago earlier this month

Cedarburg Hauser Pharmaceuticals has expanded the capacity of its Wisconsin-based API manufacturing plant as a result of an increased demand for contract manufacturing of commercial APIs as well as additional upgrades for improving safety and GMP systems.

The CPhI Pharma Awards were awarded at CPhI to recognize innovation in formulation development, drug delivery, chemical manufacturing of APIs and intermediates, and biomanufacturing. The Best Pharma Innovation award featured gold, silver, and bronze winners from five shortlisted entries. Earning the gold and top prize was Haemopharm for its needleless injection vial (NIV), a needle-free vial closure system that can be used on any product supplied in a glass or plastic vial, whether in a liquid, gel, or powder form. Merck Millipore took the silver for using bimodal silica as a drug-delivery platform. Merck Millipore’s innovation takes advantage of the two-fold pore structure of silica, which offers a large surface area and good transport properties for drug delivery. The bronze went to Bioclin for its Multi-Oral Remin remineralization gel, applied in the oral cavity to treat and prevent bleeding gums and tooth erosion. The other two finalists included Linhardt’s Multiflex collapsible tube technology, designed to improve on traditional laminate tubes, and YaoPharma’s alprostadil, formulated as a lyophilized emulsion for injection.

In addition to recognizing technical advances in drug development and manufacturing, the CPhI Pharma Awards also recognized advances in sustainability. This year’s award included an award for Best Sustainable Packaging, a new award this year that was added to recognize a company for a specific material, machine, or process that facilitated sustainable packaging. The finalists for this award included Top Clean Packaging Group’s Unicadose plastic vials, which provide an alternative to glass single-dose vials; August Faller’s Eco Save Pack, a carton tray with product-adapted inlays for different market demands; and MeadWestvaco Healthcare’s Shellpak Renew. The award went to MeadWestvaco Healthcare for its adherence-enhancing drug packaging, which consists of a recyclable tear-resistant outer carton and an easy-slide blister with a calendar integrated to aid patients in tracking their medication. In another award recognizing sustainability, Solvias won Best Sustainable Stand Design.

Dr. Reddy’s reports expansion in the areas of activated mPEG manufacturing and in the development and manufacture of APIs for use in preclinical through to commercial development at its manufacturing facility in Mirfield, United Kingdom.

DSM Pharmaceutical Products announced a biologics development and manufacturing agreement with Paranta Biosciences for Paranta’s lead recombinant human protein for DSM’s at its Brisbane, Australia, facility. DSM had earlier signed a biologics contract manufacturing agreement with Recepta Biopharma, based in Brazil. The contract covers the process development and cGMP manufacture by DSM of one of Recepta’s lead antibodies at DSM’s facilities in Groningen, the Netherlands.

Dow Chemical and Bend Research have formed an exclusive collaboration to provide science-based, spray-dried dispersion solutions and select enabling new polymers for poorly soluble oral drugs.

Encap Drug Delivery has invested $2 million to expand its facilities for equipment for product mixing and capsule-filling. Delivery of the new equipment started in August and will be completed by February 2013. In other news, Encap Drug Delivery and the School of Pharmacy, Queen’s University Belfast have received funding from the Technology Strategy Board and the Scottish Government that will allow both to enter into a collaborative Knowledge Transfer Partnership on hot-melt extrusion.

The 2012 European Outsourcing Awards were award at CPhI. Vetter’s high-speed filling line for presterilized syringes was awarded first place for the “Most Improved Manufacturing Project or Process” category. Innovations on the filling line, developed by Vetter and Bosch Packaging Technology, include an automated spray disinfection tunnel, automated end-to-end handling of tubs, and flexible equipment for various production processes in the filling station. The line is located at Vetter’s Ravensburg, Germany facility.

Catalent Pharma Solutions won the “Most Improved Plant or Facility” award for the redesign of its 221,000-ft² site in Schorndorf, Germany. The redesign included an update of all air-management systems within the entire controlled-release facility, an increase in manufacturing capacity, and optimized material flows.

Other winners included Patheon Italia for the “Most Effective Process Development/Scale-Up Program,” eResearchTechnology for the “Most Innovative Relationship,” Aesica Pharmaceuticals for the “Best New Partnership/Merger/Acquisition,” Exco InTouch for the “Best e-Business or IT Strategy”, and Anderson Brecon for both the “Best New Product” and the “Outsourcing Executive of the Year.”

In September 2012, Hospira agreed to acquire an API manufacturing facility and an associated R&D facility from Orchid Chemicals & Pharmaceuticals, an Indian pharmaceuticals company, for approximately $200 million. The proposed acquisition follows Hospira’s 2010 purchase of Orchid’s generic injectable business and permits Hospira to be vertically integrated into certain beta-lactam antibiotic APIs.

Hovione has expanded its solutions to solve issues of poor bioavailability, patient acceptability, and delivery for non-oral routes of administration. Hovione’s toolkit of solutions includes crystal design, particle-size reduction to the micro or nano-scale, and amorphous solid dispersions. These services are offered from bench to commercial scale and are complemented with formulation development and clinical manufacture to Phase II.

Jubilant HollisterStier’s contract manufacturing and services division has launched an analytical services unit that will provide laboratory method development and related analytical testing as part of its integrated service offerings.

Mayne Pharma has agreed to acquire the CDMO Metrics for an upfront payment of $105 million, plus further payments of up to $15 million based on fiscal year 2013 performance. The deal is subject to regulatory approval and customary closing conditions.

Novasep is investing EUR 30 million ($39 million) to build a chromatography plant for the production of large volumes of commercial APIs. The plant will be built on Novasep’s existing site in Mourenx, France, and is expected to be operational and validated within 18 months. The new plant will contain Varicol continuous chromatography systems with 1200-mm diameter columns operated at up to 70 bars. Novasep also recently announced an EUR 3-million ($3.69 million) investment to expand its highly potent API manufacturing capabilities at its Le Mans, France, facility. The expansion is expected to be fully operational by the beginning of 2013.

Onyx Scientific and Molecular Profiles have formed an agreement to deliver end-to-end services from initial drug discovery to early- and late-phase manufacturing.

Patheon has agreed to acquire Banner Pharmacaps , a specialty pharmaceutical business focused on the research, development, and manufacturing of gelatin-based dosage forms for $255 million. The acquisition will be structured as a purchase of all of the shares of the entities through which Banner conducts its operations subject to working capital and other adjustments. The acquisition is subject to applicable regulatory approvals and other customary terms and conditions, and is expected to close by the end of 2012.

Recipharm has received regulatory approval from French health authorities to fill biotechnology products at its site in Monts, France. The Monts site, which employs 200 personnel, comprises three filling lines. Two large capacity lines are used for glass vials for injection and a third one is an aseptic line that fills cartridges.

SAFC , part of Sigma-Aldrich, plans to expand its operations in Scotland by investing in the development of a new powder-manufacturing facility on its Irvine site. SAFC’s new facility in Irvine is its second powder manufacturing facility, which will support SAFC’s risk-management program, providing an internal back-up supplier for its customers. The new facility will be used to service customers across Europe and will create 24 new jobs. The project is being supported by a £1.5-million ($2.42 million) Regional Selective Assistance grant from Scottish Enterprise.

ScinoPharm has announced that its Tainan, Taiwan, facility will provide commercial manufacturing of topiramate, the API for Vivus’s Qsymia, a new drug for treating obesity that was approved by FDA on July 17, 2012.

SGS Life Science Services completed an expansion of its Fairfield, New Jersey, facility on Sept. 20, 2012. The expansion enlarges the size of the facility from 15,000 to 30,000 ft² by adding modernized and new GMP/GLP-compliant laboratories, and increases ICH Zone 1–4 storage capacities.

West Pharmaceutical India Packaging, an indirect subsidiary of West Pharmaceutical Services,has begun construction of its new compression molding facility in Sri City, India. The plant will become part of West’s global supply chain for its pharmaceutical packaging operations.

Xcelience opened its new 24,000-ft ² facility in Tampa, Florida, on Sept. 14, 2012. The building will be used for primary and secondary packaging, labeling, distribution, and warehouse services. This is the company’s second facility in the Tampa Bay area, and the company says it will be audited and approved for domestic as well as European clinical trials.