Cerbios-Pharma announces significant HPAPI and ADC investment

Lugano, Switzerland: – Pharmaceutical ingredient specialist Cerbios-Pharma SA (Cerbios) used the centerpiece Member Announcement Forum at this year’s DCAT Week in New York to announce on March 18th its recent addition of two high capacity High Potency Active Pharmaceutical Ingredient (HPAPI) production lines.

Cerbios’ CEO Dr. Gabriel Haering told the Forum that a new suite for ADCs will come on stream August 2019 while the HPAPI expansion facility at Lugano will be reaching full capacity by end-2020, representing a $5.5m investment program.

Batch expansion for HPAPI

Extending over two floors, the new production line will feature 630L and 1,000L Hastelloy reactors, with charging and dispensing Isolators, along with a Hastelloy Pressure-filter-dryer with discharging isolator, allowing Cerbios to safely produce and handle much larger and more varied batches of highly potent substances.

It is the second major expansion of Cerbios HPAPI facilities, following the 2008 upgrade that expanded to 40-60L units delivering batch sizes of between 200g and 2 kgs. The new line will radically expand batch sizes to 5 kgs and up to maximum 35kgs while remaining within Occupational Exposure Limit (OEL) of under 30 nanograms per cubic meter (ng/m3) to meet the most demanding Category 3 & 4 SafeBridge® guidelines.

Dedicated ADC suite

Significantly, Dr. Haering revealed also the construction of a new dedicated Antibody Drug Conjugate (ADC) suite to support Cerbios’ increasing demand in this challenging area, where Cerbios offers CDMO support to originators from monoclonal Antibody to toxin / payload, through conjugation.

He concluded by telling DCAT members that this was the latest chapter in a 25-year story of sustained Cerbios-Pharma investments in HPAPI and ADCs production. This extended back to initial Category 3&4 HPAI production unit in 1999, through successive additions and expansions in 2006 and 2008 and opening of a dedicated HPAPI R&D laboratory in 2015 to the latest high-capacity HPAPI production area and ADC suite.

Following the presentation, Dr. Haering fielded many audience and visitor questions, assisted by Chief Commercial Officer Denis Angioletti and Chief Scientific Officer Claudio Pozzoli.

“This was a very well-attended forum, with our announcements received with great interest,” said Dr. Haering.

About Cerbios-Pharma

Cerbios is a privately held company located in Lugano, Switzerland, that specializes in the development and manufacturing of both chemical and biological APIs for its partners world-wide.

Cerbios’ is a global leading supplier of a portfolio of Generic APIs primarily used in Oncology, as well as in the treatment Respiratory and Dermatological disorders.

Exclusive CDMO services are offered for the development and manufacturing of high potency active ingredients (HPAIs) as well as for biological products including monoclonal antibodies, recombinant proteins, antibody drug conjugates (ADCs) and pharma probiotics.

Cerbios provides full CMC support, including the supply of cGMP clinical batches, registration/validation material and commercially manufactured APIs, with paramount ability to supply all technical documentation and support necessary for successful registration. Cerbios’ commercial products are marketed worldwide, primarily in Europe, USA, Japan and India.

Since 2015, Cerbios has been a member of the ADC manufacture PROVEO™ consortium, forged with AGC Biologics of Denmark and with Germany’s Oncotec.

PROVEO can offer an ADCs end-to-end service from substance development through manufacturing to fill & finish.

About DCAT Member Announcement Forum

The DCAT Member Company Announcement Forum is an exclusive venue for senior executives to present short, targeted announcements to their peers and the press.

The Forum has become one of the centerpieces of the influential DCAT Week meeting staged in New York City each year by the Drug, Chemical & Associated Technologies Association, North America’s premier business development association for the pharmaceutical and chemical industries.

The Announcement Forum focuses on major news impacting the pharmaceutical manufacturing value chain, such as merger and acquisition (M&A) activity or significant new investments or manufacturing expansions.

This year’s Member Announcement Forum featured ten company leaders and was held on Day One of DCAT Week (Monday, March 18, 2019) in the Villard Ballroom of the Lotte NY Palace, sponsored by publishers Tekno Scienze (TKS).

Further information at: https://dcatweek.org/MemberAnnouncementForum.