Health protection – guidance

Biopharmaceutical manufacturing and product development

This detailed guidance was withdrawn on 15 March 2016

PHE’s clinical drug development and production capability was transferred to Porton Biopharma Limited in 2015. See Porton Biopharma website.

Information on PHE's own biopharmaceutical products including the UK’s anthrax vaccine and Erwinase™ and Erwinaze™.

Public Health England (PHE) develops new vaccines, therapeutic proteins and enzyme products.

PHE manufactures a number of its own biopharmaceutical products including:

Anthrax vaccine

PHE is the sole manufacturer of the UK’s licensed anthrax vaccine.

The vaccine is manufactured for and on behalf of the UK Government. It is supplied to the Department of Health for occupational health purposes and to the Ministry of Defence to protect service personnel from the use of anthrax as a biological weapon.

The product licence is PL 1511/0058 and is held by the Department of Health.

The vaccine can be supplied to other national governments, for more information contact the business development department at business@phe.gov.uk.

Composition of the vaccine

The active ingredient in the vaccine is a sterile filtrate of an alum precipitated anthrax antigen in a solution for injection. The other ingredients are aluminium potassium sulphate, sodium chloride and purified water. The preservative is thiomersal (0.005%).

Administration of the vaccine

The vaccine is given by intramuscular injection and the primary course of 4 single injections is followed by a single booster dose given once a year:

  • first injection: first week
  • second injection: 3 weeks after first injection
  • third injection: 3 weeks after second injection
  • fourth injection: 6 months after third injection

Precautions

No serious side effects have been reported.

Reactions are uncommon but occasionally a mild rash or swelling at the site of injection or even at the site of an earlier injection may occur and last for a couple of days. More rarely, swollen glands, mild fever, flu-like symptoms, rash, itching or other allergic reactions may occur.

The occurrence of a reaction after a first injection of the vaccine does not necessarily indicate a pre-disposition to subsequent reactions on further injections.

Erwinase

PHE is the sole manufacturer of Erwinase® which is distributed on a world-wide basis by our partners EUSA Pharma, who are an international division of Jazz Pharmaceuticals that distribute Erwinaze® in the USA.

Erwinase® is indicated for the treatment of Acute Lymphoblastic Leukaemia (ALL), a type of cancer that particularly affects children. Erwinase® is an aparinginase enzyme that is used as part of the treatment protocols in conjunction with radiotherapy or chemotherapy. The product has been particularly successful over a number of years and survival rates without remission for this type of cancer are now high.

Asparagine is an amino acid that is essential for cell growth; it is produced by most but not all cells. Mutated cancer cells in ALL rely on asparagine circulating in the blood for growth. L-asparaginases are a group of enzymes that lower circulating asparagine levels in the blood, thereby depriving the mutated blood cells of asparagine and inhibiting their growth.

There are several different types of L-asparaginase available on the market, each derived from a different bacterium. Patients receiving treatment with L-asparaginase derived from Escherichia coli (E. coli), who develop hypersensitivity to that form of the enzyme, may be able to continue treatment with Erwinase® as the enzymes are immunologically distinct. Antibodies targeting E. coli derived L-Asparaginase have been shown not to cross-react with Erwinase®.

The product is manufactured in PHE’s licensed pharmaceutical manufacturing facilities. Since its first registration in the UK in 1985 Erwinase® (Crisantaspase) has been registered in 22 countries and commercialised in more than 60 countries world wide, including approval in the US by the FDA in November 2011.

For more information about PHE’s manufacturing capabilities or the history of Erwinase manufacture, contact business@phe.gov.uk.

For information about supply of the product, contact EUSA Pharma by email at service-uk@eusapharma.com or by telephone on +44 1438 735751.

Process and analytical development

The process and analytical development group supplies a broad range of microbial products.

Services available include:

  • process development and scale up
  • non-GMP manufacture
  • product characterisation
  • analytical development and qualification
  • process and analytical validation
  • process trouble shooting
  • technology transfer

More information about the products and services available.

Biopharmaceutical production unit

The biopharmaceutical production unit works with hazardous agents including pathogens up to containment level 3 and is suitable for bio-defence related products.

The unit has 3 main facilities:

  • a bulk active manufacturing unit
  • a formulation and fill unit
  • a production support unit - which allow the manufacture of material that complies with the GMP regulations for APIs and finished products.

More information about the products and services available.

Contact

Business development

For access to our commercial products and services. Business development only. Contact switchboard or local health protection team for health protection advice.