NPIL expands high potency API facility in Scotland

By Gregory Roumeliotis

- Last updated on GMT

Related tags Pharmacology

Strong demand for anti-cancer cytotoxic active pharmaceutical
ingredients (APIs) has led Nicholas Piramal (NPIL) Pharma to
upgrade infrastructure and hire more staff at its high potency
substances (HPS) facility in Grangemouth.

The custom manufacturing business of India's fourth largest pharmaceutical company has decided to hire 16 additional technical and operation staff and invest £268,000 (€400,000) in containment upgrades at its Scottish HPS site, since the emerging monoclonal antibody (Mab)-conjugate sector is fueling growth in the cytotoxic API market.

A key element in anti-cancer chemotherapies, cytotoxics are increasingly combined with Mabs to create immunoconjugates that offer a more targeted approach to cancer treatment with fewer side effects.

Due to their precision targeting benefits, immunoconjugates are expected to take a significant share of the major worldwide oncology treatment market. The number of pre-clinical and active clinical programmes is over 20 and growing steadily.

NPIL Pharma's Grangemouth facility has a multi-product kilo scale suite, which can supply cytotoxic APIs for Phase I and II clinical trials programmes, and process development services to support pre-clinical R&D.

The new containment upgrades to an existing 500-square-metre good manufacturing practice (GMP) suite include additional high integrity barrier isolation for the safe handling of category 4-5 toxins used for conjugation to Mabs and other targeting agents. Room classification has been upgraded to class C (10,000) throughout.

Moreover, additional biochemists and purification specialists will bring the total HPS team at Grangemouth up to more than 50 specialists.

"These latest developments pave the way for significant further expansion in HPS capacity and capability,"​ said Charlie Johnson, NPIL Pharma's business manager for high potency actives.

"We will be looking to further invest on the strong dual reputation that Grangemouth has built for both its conventional synthesis and biotechnology skills."

NPIL started manufacturing anti-cancer cytotoxics at Grangemouth in 1993 and since then the facility has been expanding.

In 2003, a $2m investment brought a 450-square-metre GMP early-phase manufacturing suite on stream with a range of facilities including classification throughout to Class 100,000, a high integrity isolation unit and a Class 10,000 downflow area for low bioburden processing.

NPIL's latest investment is part of its strategy to push its pharma business, which ranges from API and intermediate development and manufacturing into final dosage forms, following its acquisition of Avecia's Pharmaceuticals business in December 2005 and of Pfizer's manufacturing facility in Morpeth in June 2006.

The company's plan is to "integrate manufacturing capability in India with acquired European and North American centres of excellence in early-phase technologies and production assets."

NPIL Pharma has four production sites in India, including R&D labs and kilo labs at Mumbai and Chennai, a GMP facility at Chennai and a commercial scale plant at Hyderabad.

The five production facilities in the UK and Canada - Huddersfield, Grangemouth, Billingham, Morpeth and Aurora, Ontario - complement the Indian network, making NPIL one of the world's top ten custom pharma manufacturers.

NPIL says it is ready for additional investment in commercial capability at Grangemouth if the strong demand for anti-cancer cytotoxic APIs continues.

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