Almac, PCI Pharma Services Expand; Pii Names New CEO

By Patricia Van Arnum - DCAT Editorial Director

January 18, 2019

 

A roundup of news from suppliers, contract development and manufacturing organizations (CDMOs), and contract manufacturing organizations (CMOs), featuring developments from Almac, Pii, PCI Pharma Services, MedPharm, and Thousand Oaks Biopharmaceuticals. 

Chemicals/Chemical API Manufacturing

Almac Invests in Continuous Flow Technology

Almac Sciences, a member of the Almac Group, has expanded its technology capabilities within its active pharmaceutical ingredients (API) services and chemical development portfolio with the implementation of continuous flow expertise at its global headquarters in Craigavon, UK, with further plans to introduce flow capacity within Arran Chemical Company, an Athlone, Ireland-based chemical company.

Almac Sciences has a four-year strategy to develop flow-assisted synthesis technology (FAST) focusing on four key areas; (1) high-pressure hydrogenations, (2) high-energy chemistry, (3) oxidation and (4) photo-redox LED mediated chemistries. To support this, Almac Sciences has been awarded a Knowledge Transfer Partnership from Innovate UK for the development of novel routes to chiral amines using flow technology. In addition, Arran Chemical Company, in partnership with Queen’s University, Belfast, has been successful in securing a Horizon 2020 funded program to support four PhD studentships for the next four years (beginning in 2019) in line with the FAST strategy.

Source: Almac

Almac Increases Peptide Capacity

Almac has brought on line a second stream for high throughput GMP peptide manufacturing at its facility in Edinburgh, Scotland. The facility manufactures neoantigen-derived peptides for use in the production of patient-specific, individualized cancer vaccines.

Almac has been active in high throughput manufacturing of neoantigen-derived peptides, branded by Almac as NeoPeptides, for several years. The NeoPeptides facility underwent a conversion from non-GMP to GMP through 2018 and has been operating in full GMP mode since September 2018. The facility has undergone a successful inspection by UK regulatory authorities and has now moved into routine GMP supply.

Source: Almac

Biologics Manufacturing

Thousand Oaks Biopharmaceuticals, a contract development and manufacturing organization (CDMO) of biologics and provider of products to support biopharmaceutical production, has closed on a $45-million Series A financing to advance its CDMO business and has started construction of a large-scale cell-culture media cGMP manufacturing facilities in Haimen, Nantong, China.

The company provides raw materials, consumables, equipment, technical services, consultation, integrated CDMO services, including cell-line development from DNA sequences, process, analytical and customized cell cultural medium development, early-phase and late-phase clinical material supply and commercial manufacturing, bioanalytical services and support for regulatory filings. The company has global footprints in China (Shanghai, Haimen, and Lanzhou) and California (Thousand Oaks and Pleasanton).

Source: Thousand Oaks Biopharmaceuticals

Formulation Development/Drug Product Manufacturing

MedPharm To Invest $4 Million to Expand North Carolina Site for Topical/Transdermal Products

MedPharm, a UK-based contract provider of topical and transdermal product design and formulation development services, has announced the expansion of its US Center of Excellence in Durham, North Carolina with an investment of $4 million. The facility expansion and equipment will more than triple the existing footprint of its US facility to 25,000 square feet. In parallel, the company has increased its liquid chromatography/mass spectrometry capacity and the automation of sample handling.

Source: MedPharm

Pii Names New CEO

Pharmaceutics International, Inc. (Pii), a contract development and manufacturing organization headquartered in Hunt Valley, Maryland, has appointed Kurt R. Nielsen, PhD, as President and Chief Executive Officer, effective immediately with the company’s January 15, 2019 announcement.

Dr. Nielsen is a seasoned pharmaceutical executive with over 20 years of experience, most recently as the President of Lupin Somerset, responsible for all their generic and branded products. Prior to Lupin, he held the post of Vice President, US Development, Portfolio and Launch Management at Sandoz Inc., where he was accountable for the US development of generic, over-the-counter, and specialty brand products.

Dr. Nielsen has also held positions at Catalent, where he was Senior Vice President of R&D and Chief Technology Officer, and URL Pharma, where he was the Executive Vice President, Pharmaceuticals. With the appointment of Dr. Nielsen to President and CEO, Pii further announces that Dr. Abidi, founder and former CEO of Pii, will transition into an advisory role and as the Executive Chairman.

Source: Pii

Packaging

PCI Pharma Services To Invest $20 Million to Expand Packaging Injectable Drugs

PCI Pharma services, a contract development and manufacturing organization of drug products and contract service provider and provider of packaging products and services, has announced an investment of more than $20 million, to expand biopharmaceutical clinical and commercial packaging and release- testing capability at its Center of Excellence in Philadelphia and to expand cold-chain capacity at several global locations.

The investment will include capacity expansion for technologies for the labeling and assembly of safety syringes, autoinjector, and pen devices with integrated high-speed cartoning, in-line serialization, as expanding onsite cold-chain storage. PCI’s injectable delivery form capabilities include ampuls, vials, cartridges and standard prefilled syringes, as well as advanced safety syringes, autoinjectors and pen devices with services for kitting for clinical and commercial applications.

Source: PCI Pharma Services