New Capabilities and Capacity From Alcami
In August, Alcami announced plans to expand capabilities and capacity for the production of highly potent active pharmaceutical ingredients (HPAPIs). With investment into 2017, the company plans to enhance new and existing facilities at its Germantown, Wisconsin facility.
This 5,000-sq.-ft. renovation will include two new, fully qualified state-of-the-art cGMP production facilities housing up to 150L reactor-scale and cryogenic capabilities, and will increase capacity by 50%. These enhancements — scheduled to be operational by Q1 2017 — will pair with Alcami’s potent drug product expertise and its existing API facility in The Netherlands to further strengthen the company’s offerings. Additionally, a recent FDA General Inspection at the facility found zero 483 observations, further illustrating the company’s expertise in and commitment to new clinical candidates.
Alcami, as the product of a merger between AAIPharma Services Corp. and Cambridge Major Laboratories, Inc., is a world-class contract development and manufacturing organization (CDMO). The company offers a suite of services from its seven global locations and boasts an advanced presence in the potent Drug Product market.
Piramal to Acquire Ash Stevens
Ash Stevens, Inc. announced that it has been acquired by Piramal Pharma Solutions, a world-class CDMO with locations in North America, Europe and Asia. As a leading provider of active pharmaceutical ingredients (APIs) and highly potent APIs (HPAPIs), Michigan-based Ash Stevens will add to Piramal’s existing presence in North America.
Ash Stevens customers are poised to gain from Piramal’s full-service, global pharmaceutical manufacturing facilities. Similarly, Piramal’s customers will benefit from the new addition of expert HPAPI services in North America, allowing for the single-source supply of HPAPIs and drug substances.
Located in Riverview, Michigan, Ash Stevens has over 50 years’ experience in the development and manufacture of APIs, including HPAPIs. The facility offers cGMP manufacturing, extensive analytical capabilities, regulatory support for all phases of development and manufacture.
“The acquisition of Ash Stevens fits well with our strategy to build an asset platform that offers value to our partners and collaborators,” commented Vivek Sharma, CEO of Piramal Pharma Solutions. “North America is a key market that we can now service with our three local facilities — the injectable facility in Kentucky for fill-finish needs, the Toronto facility for complex high-value APIs, and now Ash Stevens in Detroit for HPAPIs. Having facilities with a differentiated platform and a geographical proximity to clients are keys towards building strategic partnerships,” he added.
Two New Business Development Executives Join PCI Pharma Services
In addition to several recently announced manufacturing investments, PCI Pharma Services announced two new additions to its U.S. sales team: Sue Ritchie and Fred Schulze. Sue and Fred bring extensive experience with selling in the North American market and, together with the larger PCI sales team, will work with clients across all of PCI’s drug development services.
Previously, Sue has held positions at Delavau (most recently), Johnson & Johnson and King Pharmaceuticals, while Fred brings 30 years’ experience across the market, specifically as VP of Sales and Marketing at Coating Place Inc.
PCI Pharma Services offers extensive drug development services that pair seamlessly with their clinical trial packaging, labeling and logistics offerings, as well as the company’s commercial packaging capabilities. From phase 1 clinical trials through commercial-scale production and supply, PCI has been serving the larger healthcare industry for more than 40 years.
“We are delighted to welcome Sue and Fred to the PCI team. They bring extensive experience in selling services within the USA market to our client base of pharmaceutical and biotech companies, which will greatly support our continued growth ambitions.” Rob Jones, Executive Director of Business Development, PCI
Icagen and the Nanion SyncroPatch384 Platform
Icagen Inc. is proud to announce the purchase of a SyncroPatch384 high-throughput electrophysiology instrument from Nanion Technologies, Inc. The companies have entered into an agreement focused on the development of ion-channel assays using this platform. Since purchasing the technology, multiple assays have been developed by Icagen. Douglas Krafte, Ph.D., the company’s Chief Scientific Officer, believes SyncroPatch 384 is perfect for managing extensive cell line inventory and sees high value in Nanion’s expertise. “We evaluated the available options in this technology space and are excited to have acquired the Nanion platform and to be working with this company. We feel that the SyncroPatch384 is the ideal mechanism to leverage Icagen’s decades of ion-channel drug discovery experience and extensive inventory of cell lines for our customers and clients. In addition, we value the relationship with Nanion and the very high quality of engagement and depth of expertise of their people,” Krafte commented.
Similarly, Nanion’s vice president, Rodolfo Haedo, agrees that the joining of Icagen’s ion-channel discovery experience and Nanion’s technology will help to advance the field. Overall, the purchase is intended to improve Icagen’s customer response regarding the expedited development of some of their clients’ more challenging discovery targets.
Nanion Technologies has a global presence (Europe, North America and Asia) and 14 years’ experience developing instruments for high-quality ion-channel research. Icagen is an ion-channel leader, with a growing toolbox that includes the XRpro® platform. XRpro® technology, enables high-throughput assessment of ion channels and transporters using X-ray fluorescence.
“We feel that the SyncroPatch384 is the ideal mechanism to leverage Icagen’s decades of ion-channel drug discovery experience and extensive inventory of cell lines for our customers and clients.” – Douglas Krafte, Ph.D., Chief Scientific Officer of Icagen, Inc.
Coperion Co-Hosts Continuous Direct Compression Seminar
Coperion K-Tron, a buisness unit of Coperion, recently joined forces with Fette Compacting, Glatt Air Technologies, QdB Process Technologies and C-SOPS to present a one-of-a-kind, hands-on seminar. Held at Rutgers University’s Pharmaceutical Research Center in Piscataway, New Jersey, this seminar educated participants on several technologies, including continuous operations, tablet press operations, process design and integration, and PAT.
Attendees were encouraged to actively participate, while also learning from technical presentations and an integrated direct-compression line. Those interested in taking additional advantage of the expertise offered by the team of companies were invited to participate in a second day of training with topics including continuous dry granulation.
Based in Salina, Kansas, Coperion designs, develops, manufactures and maintains systems and machines for various industries, including pharmaceuticals. Coperion K-Tron, one of the company’s business units, is a leader in the supply of material handling and feeding systems.
Icagen Acquires Sanofi Facility
Icagen has officially completed its acquisition of Sanofi’s Oro Valley, Arizona research facility, approximately 15 miles north of Tucson, Arizona. The acquisition of Sanofi’s ultra-high-throughput biology, screening and chemistry capabilities enhances Icagen’s current expertise as a specialized pharmaceutical company with a heightened capability in ion channels and transporters. As part of this agreement, Icagen and Sanofi will collaborate in a multi-year services contract on long-term discovery services.
Icagen’s management of a vast Sanofi compound library makes it more accessible to potential partners, thereby increasing the potential for drug discovery. This facility has been operating since 1990 — though not always under Sanofi ownership — and offers capabilities in discovery biology, cell models, human biomarkers and stem cell–based assays.
Avara Acquires New Manufacturing Facility
In August, Avara Pharmaceutical Services, Inc. announced its acquisition of Astellas’s wholly owned manufacturing facility in Norman, Oklahoma. All employees will remain at the Norman site, which will continue to manufacture certain Astellas products on a contract basis. Under this agreement, Avara will oversee Astellas’s continued sourcing of a stable supply of high-quality products from the facility.
Regarding the acquisition, Tim Tyson, Chairman and CEO of Avara, commented, “We are excited to have the APT organization join the Avara team and to add this significant capability to the Avara company. We are honored to have the strategic partnership with Astellas and to manufacture key products for them.”
Avara Pharmaceutical Services, Inc., is a Norwalk, Connecticut–based company with facilities in North America and Europe. As a CDMO with broad industry experience, Avara aims to exceed customer expectations with in-full, on-time delivery.