A roundup of the latest expansions and manufacturing updates from suppliers, contract development and manufacturing organizations and contract manufacturing organizations, featuring news from Recipharm, Hovione, Quotient Sciences, Jost Chemical, and Vetter Pharma.

Formulation Development/Drug Product Manufacturing

Recipharm Decides To Continue Mfg Ops at Höganäs, Sweden Facility; Receives GMP Notice on UK Facility
Recipharm has decided to continue manufacturing operations at its solid dose facility in Höganäs, Sweden, which the company had earlier planned to discontinue.

In 2017, Recipharm announced the intention to discontinue the operations in Höganäs and evaluate different options for the facility, including divestment of the site. During this evaluation, Recipharm says new customers have approached the company for adding demand for several new products at the facility in Höganäs. As a result, Recipharm is now reversing the decision to discontinue the operations in Höganäs. 

In separate news, following a routine audit, the UK Medicines and Healthcare Products Regulatory Agency (MHRA), the UK pharmaceutical regulatory authority, has restricted the manufacturing license for five non-critical highly potent products supplied from Recipharm’s facility in Ashton-u-Lyne, UK. This was due to deficiencies in certain of the manufacturing procedures, which represented a potential cross- contamination risk. The citation was noted in a filing posted on EudraGMDP, a database of the European Medicines Agency providing information from the national regulatory authorities of the member states of the European Union, Iceland, Liechtenstein and Norway, on manufacturing and import authorizations, GMP certificates, statements of non-compliance with GMP, GMP inspection planning in third countries, and related information on good distribution practices.

Recipharm’s facility in Ashton-u-Lyne, primarily manufactures non-potent solid dose products. In addition, highly potent products are manufactured in a separate dedicated area.

Following the audit, the company reports that production was immediately suspended to ascertain the risks, and the company liaised with the MHRA and customers regarding remediation plans. These plans have been endorsed by the MHRA and are being executed, according to the company. Supply has recommenced and will continue in a phased manner for the non-restricted products. Recipharm says that it is unlikely that this issue will cause significant supply interruptions and it expects that the license restriction will be completely lifted by the end of the year. The company expects that the financial effect of this issue on its fourth quarter results will be less than SEK 10 million ($1.1 million).

Source: Recipharm (Swedish facility)  and Recipharm (UK facility)

Formulation Development/Drug Product Manufacturing

Hovione To Increase Oral Dosage Production Capacity
Hovione plans to increase production capacity in oral dosage forms in Portugal, to strengthen its integrated offering. New commercial-scale equipment for blending, tableting, and coating will be added to complement existing development small-scale equipment. One year ago, Hovione started offering end-to-end capabilities from drug substance to drug product from its site in Loures, Portugal.

In parallel Hovione will be completing by the end of 2018, the qualification of a continuous tableting line at its facility in New Jersey, which will enable the site to offer end-to-end capabilities in the US.

Hovione began a capacity-expansion program in 2016 and says it will continue the program in the coming five years. In the first two years, Hovione relocated its development services to a new center with 7.000 square meters in Lisbon, Portugal for handling potent and highly potent compounds. Globally within its R&D activities, it added new labs, new drug-product centers, pilot plants, and particle- engineering technologies both at its sites in the US and Portugal. It expanded its site in Loures with drug- substance reaction-vessel capacity with a small-scale production area and a new pilot plant. It also installed more spray-drying capacity at the site and started the operation of a new drug product center equipped with oral dosage form and inhalation manufacturing capabilities. In New Jersey, Hovione doubled the size of its development and manufacturing operations. In Cork, it expanded its chemical synthesis capacity devoted to contract manufacturing.

Source: Hovione

Formulation Development/Drug-Product Manufacturing

Quotient Sciences Expands US Operations
Quotient Sciences, a Nottingham, UK-based contract development and manufacturing organization, has opened a new 45,000-square-foot facility near Philadelphia, Pennsylvania. The $15-million investment will create a center of excellence for early-phase formulation development and clinical trial manufacturing.

The site will focus on developing small-molecule oral drug products, supporting development programs from the preclinical stage through to clinical proof-of-concept.

Source: Quotient Sciences

Chemicals/Chemical API Manufacturing

Jost Chemical Begins Construction on Manufacturing Site in Poland
Jost Chemical, a manufacturer of high purity chemicals, has begun construction on a new 4,600-square-meter building that will be located in Kościan, Poland. The site is expected to come on line in the fourth quarter of 2019.

Upon completion, the new facility will become a part of Jost Chemical’s integrated global network. This facility will produce high purity specialty salts for the pharmaceutical, biopharmaceutical, nutrition, and clinical nutrition industries.

Source: Jost Chemical

Packaging

Vetter Further Expands Secondary Packaging
Vetter Pharma, a Ravensburg, Germany-headquartered contract development and manufacturing organization for aseptic filling and final packaging of injectables, is expanding secondary packaging at its Ravensburg site with the addition of 2,900 square meters in a new building by 2020.

The expansion adds to the existing area of approximately 6,000 square meters.

The extension also includes investments in modern testing and analysis methods. In addition to standard release and stability tests, e.g. syringes with a needle shield, the company expects to offer more extensive tests for autoinjectors beginning in March 2019.

Source: Vetter Pharma