Particle Sciences expands controlled substance capabilities

27 May 2019

Now authorized to test, develop and manufacture cannabis-derived pharmaceutical materials.

CDMO Particle Sciences has broadened Drug Enforcement Administration (DEA) registration to become an authorized manufacturer of Schedule I substances. The expanded registration was granted following inspection by the DEA and will allow Particle Sciences to carry out analytical testing, development and manufacturing of cannabis-derived materials to be used in pharmaceutical applications for medically justified, legal uses in the US.

Particle Sciences expands controlled substance capabilities

Particle Sciences already has infrastructure in place to develop and manufacture Schedule II - V controlled drug products at its facility in Bethlehem, PA, and has worked on a number of projects in the past ranging from a novel nasal delivery system for diazepam to long-acting buprenorphine dosage forms. Under its new Schedule I registration, the company will build further on this infrastructure and open a new area of development for customers looking to take products through the traditional clinical trial and approval process.

Robert Lee, president of Particle Sciences states, “Particle Sciences has built a solid reputation and specialized expertise in controlled substances as a result of our team’s work in complex formulations with substances in Schedules II - V.” Lee continues, “A high level of ethical standards and water-tight controls/processes including accurate documentation are essential to carry out controlled substances work and these are already firmly ingrained in our day-to-day operations.”

In 2018, the FDA approved its first cannabis-derived drug, Epidiolex, for the treatment of seizures associated with two rare and severe forms of epilepsy. It has since announced a series of significant steps to develop a regulatory pathway for cannabis-derived products, including the formation of a high-level internal agency working group.

Barbara Morgan, general manager of Particle Sciences comments: “The Schedule I registration will open up opportunities for us to work with clients with appropriate sources of controlled substances to further investigate the therapeutic value and effects of these compounds and help shape this emerging area of medicine.”

The expanded registration is the latest step in Particle Sciences’ broadening of its manufacturing capabilities as part of a wider investment by Lubrizol LifeSciences. The company recently opened a new commercial facility to accommodate production of complex sterile and non-sterile finished drugs and appointed new vice president of operations, Karen Bossert.

Read More

Related news

Recipharm expands Indian injectable dosage form capabilities

Recipharm expands Indian injectable dosage form capabilities

7 Nov 2019

Partnership will combine capabilities and expertise in Europe and India to build a new facility dedicated to injectable formulations to supply demand from Europe and overseas territories.

Read more 
Aptar acquires a leader in drug delivery training devices and patient onboarding

Aptar acquires a leader in drug delivery training devices and patient onboarding

6 Nov 2019

Acquisition reflects movement of treatments being administered by patients at home rather than by healthcare providers.

Read more 
Europe predicted to surpass the US in biologic manufacturing capacity by 2023

Europe predicted to surpass the US in biologic manufacturing capacity by 2023

6 Nov 2019

Demand for biological manufacturing is growing faster than capacity growth.

Read more 
SP acquires Spain based global provider of complete sterile filling lines

SP acquires Spain based global provider of complete sterile filling lines

5 Nov 2019

Company's strategic move reflects its expectation of short-run aseptic liquid filling to continue to drive pharmaceutical growth.

Read more 
Legacy recruits heavily to meet growing steriles demand

Legacy recruits heavily to meet growing steriles demand

5 Nov 2019

Company to reach 250 employees by year end to meet growing drug product manufacturing demand.

Read more 
China on course for 'massive' bio capacity shortfall

China on course for 'massive' bio capacity shortfall

4 Nov 2019

A shortage of qualified personnel may be a drag factor in cell and gene therapies; in China 100,00L of capacity will need to be added every year to meet bio demand.

Read more 
Recipharm launches new service to support companies with QC and analytical requirements

Recipharm launches new service to support companies with QC and analytical requirements

1 Nov 2019

Services including method development, method validation, and stability program design and implementation.

Read more 
Evonetix expands to develop its desktop DNA synthesis platform

Evonetix expands to develop its desktop DNA synthesis platform

31 Oct 2019

15,000 sq. ft of laboratory and office space will enable continued growth and development of the company’s integrated desktop platform for DNA synthesis.

Read more 
The way forward? Collaborate with robots

The way forward? Collaborate with robots

30 Oct 2019

Vetter increasingly relies on close interaction of humans and machines for greater flexibility.

Read more 
The benefits of transitioning from paper-based to paperless batch record management

The benefits of transitioning from paper-based to paperless batch record management

29 Oct 2019

Free webinar to discuss the benefits of a collaborative approach to implementing an electronic batch record platform.

Read more