Life Sciences

Contract development and manufacture for life sciences

By Bernard Pluta President Development Services Recipharm

Stockholm, Sweden-headquartered Recipharma supplies a range of contract manufacturing and development services to the pharmaceutical industry and has recently made several new investments in its facilities to meet increasing customer demand.

Recipharm, a leading pharmaceutical industry contract development and manufacturing organization, offers manufacturing services for pharmaceuticals in various dosage forms, production of clinical trial material and APIs, pharmaceutical product development, and development and manufacturing of medical devices. The company manufactures several hundred different products for customers ranging from Big Pharma to smaller research and development companies and operates development and manufacturing facilities throughout Europe and the US. Recipharm is headquartered in Stockholm, Sweden.

The company recently announced that it is investing $2.5 million in clinical GMP capacity for active pharmaceutical ingredients at its plant in Israel and says the investment will support  growing demand for cGMP clinical supply of APIs and intermediates as part of an integrated plan to enhance Recipharm’s offering in drug substances services.

The investment will see the implementation of a full GMP chemical unit, including a number of brand-new R&D laboratories and technologies, which, the company says, will allow it to support customers through their development projects, from early medicinal chemistry into commercialization, through a single integrated flow. The expansion is expected to be fully operative by the end of 2021.

Recipharm’s facility in Israel is located south of Tel Aviv in the vicinity of the Weizmann Science Park, where its team specializes in medicinal chemistry. The company’s offering includes a wide array of services in chemical synthesis and analysis, including some very demanding and novel specialities. The company also offers analytical and preclinical services.

Softmist technology for pharmaceutical applications

In November this year, Recipharm and Medspray, a manufacturer of high-tech spray nozzles, announced that they had established a joint venture, known as Resyca BV, to exploit novel softmist technology for pharmaceutical applications. Under the agreement, Recipharm will invest $15 million in return for 51% of the shares of Resyca and Medspray will transfer its softmist intellectual property relating to pharmaceutical applications into Resyca. The technology has the potential to eliminate the need for propellants by delivering therapies deep into the lungs more effectively with lower doses as less ends up in the mouth and throat.

Recipharm’s investment in Resyca will be made through its subsidiary Recipharm BV and Resyca will operate development facilities in Munich, Germany. The spray nozzles will be supplied exclusively from Medspray in the Netherlands and it is envisaged that commercial supply of finished devices will be manufactured and supplied by other Recipharm affiliates, including the company’s specialist device manufacturing business located in King’s Lynn, UK. Additionally, Recipharm will receive an exclusive licence to offer its customers the development and manufacturing of syringe-based devices using softmist nozzle technology. Such devices will be marketed by Recipharm under the brand name Bespak.

Recipharm has also announced an investment into its King’s Lynn facility to expand the company’s pressurized metered dose inhaler (pMDI) valves production capacity. The new capacity is set to come on stream in late 2021. The investment follows the acquisition by Recipharma of Consort Medical earlier this year and the subsequent launch of the specialist medical device brand Bespak.

Aseptic fill-finish manufacturing of coronavirus

Also in November, Recipharm signed a letter of intent with US-based biotech company Moderna, to formulate, fill and finish mRNA-1273, Moderna’s COVID-19 vaccine candidate. The activity will be performed in Recipharm’s drug product manufacturing facility located in Monts, France where the company has reserved capacity to support the expected demand for the vaccine. Recipharm is already in the process of recruiting additional staff and making certain investments to enable technology transfer and scale-up to commence “imminently”.

COVID-19 add-on treatment study

In October this year, Recipharm announced the results of its study with Erdosteine as an add-on treatment for COVID-19 patients. This clinical study involved 20 patients affected by COVID-19 with severe respiratory failure, hospitalized in one of the major COVID-19 centres in Milan in Lombardy, the region of Italy mostly affected by SARS-CoV-2. The study indicates that patients taking Erdosteine after hospital discharge benefit significant improvements in health-related quality of life parameters (HRQoL) and dyspnoea. The study is one of the first to report HRQoL details in patients with COVID-19 and opens up new perspectives for the use of Erdosteine in COVID-19 patients, most likely due to its multiple mechanism of action (antioxidant, mucoactive, anti-inflammatory, antibiotic enhancer) and its ability to increase the endogenous levels of glutathione. This may have blocked the spreading of the virus in the lungs giving a faster recovery to patients treated.

Erdosteine was discovered and developed in Italy at Recipharm’s facility in Paderno Dugnano and is indicated for the treatment of acute and chronic respiratory diseases including (COPD). Erdosteine is a thiol, discovered in Italy in the Research and Development laboratories of Edmond Pharma, and is particularly effective in the treatment of respiratory diseases, such as acute bronchitis, chronic bronchitis and COPD. It modulates mucus production and viscosity and increases the motility of the mucociliary transport, improving expectoration. Its clinical efficacy, combined with its safety profile, has been proved by more than 3,000 patients treated in 60 clinical trials and by a more than ten-year experience in clinical practice worldwide.

Recipharm invests EUR 2.6 million in Kaysersberg facility

Recipharm also announced in October that it was investing €2.6 million in its Kaysersberg, France sterile manufacturing facility, adding capacity and capabilities to support new business for the future. The latest investment is part of the company’s phased expansion plan for the facility. The facility specializes in producing sterile liquids for therapeutic areas including eye care and ear drops and has been inspected and approved by multiple regulatory agencies worldwide. It also holds a number of approvals for its environmental management systems and occupational health and safety management systems.