Piramal expands its high potency API capability

25 Jun 2019

Becomes one of only a few companies in the contract development and manufacturing market that can produce HPAPIs at such low OELs.

CDMO Piramal Pharma Solutions (PPS) has opened a new wing at its Riverview site dedicated to the production of high potency active pharmaceutical ingredients (HPAPIs) with low Occupational Exposure Levels (OELs). The total investment required to upgrade the site was approximately $10 million, which includes a new QC/analytical lab and two kilo-labs, as well as a doubling of the office space, which was needed to support the dramatic growth at the Riverview site.

Piramal expands its high potency API capability

To date, the Riverview site has had the containment capability and engineering controls to safely handle HPAPIs with OELs down to 1 mcg/m3, at scales ranging from grams to approximately 250 kilos. The new wing, which consists of two kilo-labs and a QC/analytical lab, brings more to the table. It has been designed with the required engineering controls and containment solutions to handle HPAPIs with OELs <1 mcg/m3 and as low as approximately 20 ng/m3. Materials will primarily be produced in this new wing at kilo-lab scales; lots of <5 kilos can be produced in this new state-of-the-art facility.

Vivek Sharma, CEO, Piramal Pharma Solutions said: “We are one of only a few companies in the contract development and manufacturing market that have the capability to produce HPAPIs at such low OELs. It’s another example of how we remain committed to partnering with our customers to serve the patient community and reduce the burden of disease.”

Historically, the site operated as one shift, 5 days a week. Today, the site operates 12 hours a day, 7 days a week, and is headed towards being a full 24/7 site. The Riverview site expansion also provides significant benefits to the local economy, including the addition of new high-tech jobs. The local staff has increased from 80 to 127 people, with a projected total of approximately 150 employees in the near future. This includes high-tech staffing of PhD and BS degreed scientists, plus manufacturing operators and other skilled workers.

Vince Ammoscato, Vice President and Riverview Site Head, added: “This new, enhanced capability opens the site up to a new base of customers, including the antibody drug conjugate (ADC) market. We are equipped to offer ADC customers a seamless end-to-end solution since we can develop the HPAPI payloads and linkers here in Riverview, send them to our site in Scotland for the antibody conjugation, then back to our Lexington, Kentucky site for sterile fill and finish.”

The ability to offer a fully integrated solution for the ADC market – from proof-of-concept studies to conjugation development, clinical and commercial ADC GMP batch manufacturing and fill/finish – represents a significant strategic advantage for Piramal Pharma Solutions.

According to Mr Ammoscato, more expansions are forthcoming. There is additional real estate available on the site for added capacity and new capability enhancements that will be designed to match the market needs of the pharmaceutical industry.

Read More

Related news

Fresh data on protein interactions in Alzheimer’s disease

Fresh data on protein interactions in Alzheimer’s disease

2 Jul 2019

Demonstrates the unique ability of diffusional sizing to assess protein binding in-solution and for difficult-to-study systems.

Read more 
Inaugural Bio Integrates conference highlights industry's inefficiency in developing products

Inaugural Bio Integrates conference highlights industry's inefficiency in developing products

18 Jun 2019

Industry leaders give voice to issues and trends shaping the biotech sector, including the importance of collaboration.

Read more 
PASCOE Naturmedizin exhibits at CPhI Worldwide Exhibition in Frankfurt

PASCOE Naturmedizin exhibits at CPhI Worldwide Exhibition in Frankfurt

18 Jun 2019

PASCOE Naturmedizin is one of Germany's 100 most innovative medium-sized enterprises. The success story of our family’s specialist naturopathy company began three generations and almost 125 years ago when Friedrich H. Pascoe's first pharmacy in Mülh...

Read more 
Liquid pharmaceuticals in the digital age

Liquid pharmaceuticals in the digital age

30 May 2019

Inspiration, innovation and technical highlights from Bosch Packaging Technolgy's Pharmatag 2019.

Read more 
CPhI China opens with analysis pointing to a surge in growth in 2019

CPhI China opens with analysis pointing to a surge in growth in 2019

28 May 2019

Regulatory reforms and harmonisation reported as key drivers of industry in China.

Read more 
Expert forecasts huge growth in Middle East manufacturing

Expert forecasts huge growth in Middle East manufacturing

16 May 2019

UAE consumers and insurance companies are willing to pay for highest quality drug products.

Read more 
Lessons learned from early EU FMD adopters

Lessons learned from early EU FMD adopters

13 May 2019

Data exchange, investment costs, resources and hardware identified as some of the biggest challenges.

Read more 
Manufacturing growth sees surging demand at CPhI South East Asia

Manufacturing growth sees surging demand at CPhI South East Asia

3 May 2019

Number of visitors seeking a contract manufacturer was extremely high, with multinational corporations increasingly looking for local partners to expedite market access into the wider region.

Read more 
Sirio’s Ayanda launches probiotic softgel

Sirio’s Ayanda launches probiotic softgel

23 Apr 2019

Patent-pending technology is the first ever to enable a softgel capsule to contain both probiotic bacteria and Omega 3 oil.

Read more 
Surge of Indian biosimilars market forecast in 2019

Surge of Indian biosimilars market forecast in 2019

22 Apr 2019

India predicted to be one of the world’s ‘fastest growing bio’ hubs in 2019, fuelled by new biosimilars production.

Read more