Aesica - API Supply, Development and Manufacture

Aesica supplies contract development and contract manufacturing services for active pharmaceutical ingredients and formulated products to a host of the world's leading pharmaceutical companies and emerging biotechnology organisations.

Aesica offers comprehensive contract manufacturing services for primary and secondary pharmaceutical products, from early clinical phases through to market production. Our products and services are distributed to the world's major pharmaceutical markets.

Active pharmaceutical ingredients

Aesica has over 25 years of experience in supplying bulk APIs and providing API contract development and manufacture to the global pharmaceutical industry, building a reputation for reliability, quality and service that has made us the partner of choice for many of the world's leading companies.

Aesica's impressive and modern facilities offer a comprehensive range of development services and manufacturing capabilities to advance products from early phase clinical development right through to commercial supply.

API contract development

Aesica provides the following API contract development services.

Kilo lab:

• Process development and technical transfer to pilot or commercial scale
• Ability to handle multi-stage complex processes
• Equipped with all standard tools of an organic synthetic laboratory
• Mettler RC1 calorimeter / reactions 20l-40l scale
• Short path distillation devices (1.5kg/hr)
• GC and prep HPLC
• Walk-in hoods
• Distillation, drying facilities and hydrogenation capability
• GMP storage facility

Pilot plant:

• Dual facilities ideal for process scale-up
• Walk-in drum booth with extraction
• Hastelloy filter drier with glovebox isolation technology
• Glass-lined reaction vessels up to 250l volume
• Ideal for 10kg to 100kg manufacture
• -20°C to 150°C reaction temperature capability
• Operates to cGMP standards
• Complemented by scale-up laboratory operating at 50l scale
• Continued investment and broadening of capability

Analytical development:

• Automated HPLC and GC
• IR and UV
• LC – MS
• GC headspace analysis
• Particle size by laser diffraction
• GCMS
• Preparative HPLC
• Photostability cabinet for stress stability studies
• In-house stability sample storage and analysis in compliance with ICH
• Analytical validation and technical transfers completed according to defined protocols in compliance with ICH
• Reference materials supplied with CoA
• All equipment qualified and certified

API contract manufacturing

Aesica's commercial scale API manufacturing facilities include seven cGMP compliant computer-controlled multi-product plants all with extensive chemical processing capabilities, some of which include high potency facilities. Between them these facilities offer processing options at a wide range of scales, from a few kilograms up to hundreds of tonnes.

API products

Aesica is also a leading supplier for the following range of APIs:

Flurbiprofen

Flurbiprofen is a non-steroidal anti-inflammatory medication (NSAID) used to relieve pain, tenderness, inflammation and stiffness caused by arthritis. Aesica has a US DMF and a European DMF and sells material into every continent. It has been granted the Certificate of Suitability by the European Directorate for the Quality of Medicines (EDQM).

R(-) flurbiprofen

Purified enantiomer of flurbiprofen in development for various indications.

S(+) flurbiprofen

Purified enantiomer of flurbiprofen in development for various indications.

Paroxtine hydrochloride

Paroxetine is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) type. Aesica has both European and US DMFs for this product and is currently supplying leading generic customers.

Dothiepin hydrochloride

Dothiepin (dosulepin) is a well-trusted tricyclic anti-depressant with some tranquillising properties. Aesica has a European DMF for dothiepin and has manufactured it for many years.

About Aesica

Aesica is one of the UK's fastest growing companies and over the last five years has experienced an increase in turnover from £25m to approximately £100m. In addition to its headquarters in Newcastle upon Tyne, UK, Aesica has four development and manufacturing sites across the UK including Cramlington, Queenborough, Ponders End and the recently acquired R5 Pharmaceuticals in Nottingham. Furthermore, Aesica has offices in New York, San Diego and Shanghai and employees 750 people.