Almac provides chemistry and manufacturing solutions for APIs from discovery through commercialization. They offer multi-purpose GMP manufacturing facilities, process R&D, preclinical through commercial API supply, analytical development and validation, potent API production, biotransformation, micronization, and process validation using quality by design approaches. Almac has expertise in chemical development, biocatalysis, physical sciences, formulation development, and analytical services to support clients' API needs.

1. API Supply
Providing chemistry and manufacturing solutions from discovery to launch
> Multi-purpose GMP plant
> Process research and development
> Preclinical to commercial supply
> Analytical development and validation
> Highly potent API manufacture
> Biotransformation
> Micronisation
> Process validation using Quality by
Design and DoE approaches
API Services &
Chemical Development
www.almacgroup.com

2. www.almacgroup.com
API Supply
Commercial Services
Almac deeply understands the challenges within each stage of the drug development process and has
the technical expertise, facilities and commitment to offer complete solutions for API supply to the highest
quality. Combining our established track record and our strong quality culture, our integrated project teams
(comprising chemistry, biology, analysis, physical sciences, preformulation, production, quality and project
management) offer an industry leading service in the supply of APIs, making us the partner of choice.
Clinical Technologies
Supporting Capabilities
cGMP Manufacture Chemical Development and
> Manufacturing for clinical and Biocatalysis
commercial supply. > Rapid route scouting.
> Highly potent API production and micronisation. > Non cGMP kilolab for rapid scale-up.
Clinical Trial Supply
> Dedicated cytotoxic manufacturing facility. > Fit for purpose process development.
> Photochemistry; ozonolysis; cryogenic • Impurity tracking.
capabilities. • Genotoxic impurity control.
> Integrated drug product manufacturing. • Reference standard.
> Almac has an excellent regulatory history > Biocatalytic route invention.
and maintains multiple FDA inspected > Enzyme screening and rapid supply for
facilities in UK and USA. scale-up.
Analytical Services
> Metabolite synthesis.
Physical Sciences
> Polymorph, Salt & Cocrystal Screening. Analytical
> Physical Form Selection. > Method development & transfer.
> Crystal Modification. > Method validation.
> Crystallisation Development & Troubleshooting. > Impurity identification.
> Physical Form Characterisation. > Genotoxic impurity analysis.
Pharmaceutical Development
> Pre-formulation & Formulation > Stability studies.
Development Services. > Full batch release testing.
Case Study
Our client required first time
API Services & Chemical Development
scale-up of their lead candidate to
support animal toxicology and
First-in-Human clinical batches.
Challenges with this 10-step linear synthesis included yield, operability and control
of impurity levels and polymorphic form.
This project was successfully completed on time, with the following key deliverables:
> Overall yield was increased from 4.5% to 22%. > Control of enantiomer purity using in-house
> 500g, 12kg and 56kg deliveries. biocatalysis expertise.
Biomarker Discovery & Development
> Improved operability. > Control of polymorphic form.
> Control of impurities, including genotoxics. > Mechanistic understanding of a key step.
For European Enquiries: For American Enquiries:
Almac Almac Group Incorporated
Sciences 25 Fretz Road
Almac House Souderton, PA 18964
20 Seagoe Industrial Estate, United States of America
Craigavon, BT63 5QD, T +1 (215) 660 8500
United Kingdom. E: sciences@almacgroup.com
T: +44 (0) 28 3833 2200
E: sciences@almacgroup.com
www.almacgroup.com