Almac provides radiolabeling services including the synthesis of 14C labeled APIs and drug products for human ADME studies. They have a 14C manufacturing license and cGMP compliance. Almac uses integrated teams of radiochemists and analytical experts along with state-of-the-art facilities to efficiently develop and manufacture radiolabeled compounds. Case studies demonstrate successful projects involving peptide radiolabeling and developing powder-filled capsules and sterile solutions for clinical studies.

1. Radiolabelling
Meeting your isotopic labelling needs throughout drug development
> Supply of API & IMP
> Comprehensive product analysis
> Storage and repurification
> Stability testing
> 14C peptide synthesis
> MHRA 14C manufacturing licence
and cGMP compliance certificate
API Services &
Chemical Development
www.almacgroup.com

2. Radiolabelling cGMP Radiolabelling for Human
Meeting your isotopic labelling needs throughout drug development.
ADME Studies
Commercial Services
Almac has the knowledge, expertise and commitment to meet your isotopic labelling needs.
Combining our established track record in 14C labelling with our strong quality culture, we offer an Almac offers an industry leading service in the preparation of 14C labelled APIs (Drug Substance) and IMPs (Drug
industry leading service in the preparation of 14C labelled drug substance and drug product which will Product) for human ADME studies.
meet your quality, cost and delivery time expectations.
Clinical Technologies
Almac holds a 14C IMP (Investigational Medicinal Product) licence and a cGMP compliance certificate issued by
Supporting Capabilities the MHRA. We employ highly trained radiochemists and analysts utilising state of the art facilities and equipment.
We can offer our customers savings in both time and cost through effective integration with our other
service areas (e.g. API manufacture; formulation and analytical services).
Chemistry and Biocatalysis Physical Sciences
> Route design and implementation, > Physical form selection and
Clinical Trial Supply
including identification of suitable characterisation
labelling position. > Control of particle size by milling
> Complementary stable isotope > Preformulation and formulation Supporting Capabilities
labelling. development services
> Biocatalysis reaction options.
Quality and HSE Chemistry and Biocatalysis
Analytical
Analytical Services
> MHRA 14C manufacturing licence
> Analytical method transfer. > GMP compliant synthesis and release of > Comprehensive analysis of 14C materials to
and cGMP compliance certificate
14C API and drug product
> Analytical method development > Active environmental stewardship. support release of 14C APIs and IMPs,
and validation. > Manufacture of 14C oral dosage and including:
> Full compliance with all relevant
injectable drug products. • Characterisation of product and
legislation.
> Expertise in development of conditions to determination of purity levels of product-
control morphic form, and ability to related and non-product-related
Pharmaceutical Development
control particle size by milling substances (including solvent
where required. determination, metals analysis).
> QP release. • Solid form of the API using particle size
Case Study 1 > Stability storage and testing. and XRPD analysis.
> Storage and repurification. • Disintegration/dissolution analysis for
Our client required synthesis of 25mCi > Active environment stewardship and full capsules.
of non cGMP material for ADME studies. compliance with all relevant Health • Analytical method transfer / development.
and Safety legislation
The synthesis of unlabelled API was not
API Services & Chemical Development
suitable for a 14C synthesis.
> Route was redesigned and implemented > 29.5mCi of in-spec. material was supplied
from available starting materials to the client. (Kitson et al, J. Lab. Compd.
(14C barium carbonate). Radiopharm., 2010, 53(3), 140-146.)
Case Study 2
Our client required synthesis of a 14C
Biomarker Discovery & Development
labelled biotinylated 84mer peptide.
The project required expertise in peptide
chemistry and analysis, radiochemistry
and purification.
> Successful project delivery by an integrated peptide chemistry / radiochemistry team.
> Stability study performed.
> 2mg of in-spec product was delivered to our client.
www.almacgroup.com

3. www.almacgroup.com
Commercial Services
Case Studies
Clinical Technologies
Case Study 1
Our client required synthesis of this
target molecule, presented as
Powder-in-Capsule IMP.
Clinical Trial Supply
> Chemistry and analytical methods successfully transferred in-house.
> cGMP synthesis of API.
Analytical Services
> API stability study.
> Powder-in-Capsule IMP manufacture.
> XRPD analysis to confirm morphic form.
> Almac QP release of IMP.
Pharmaceutical Development
Case Study 2
Our client required synthesis of this target
molecule, presented as a sterile filtered
ethanolic solution.
API Services & Chemical Development
> Chemistry and analytical methods successfully transferred in-house.
> cGMP synthesis of API.
> API stability study.
> Seamless project management of sterile filtered ethanolic solution IMP manufacture.
> Customer QP release of IMP.
Biomarker Discovery & Development
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