Almac Sciences

Almac’s Peptide and Protein Technology (PPT) group has been manufacturing peptides for the research community and clinical trials development since 1994. We place significant emphasis on peptide synthesis methodology and have manufactured well over 10,000 peptides for the research community. Focussing on the delivery of high quality products, we have developed a highly differentiated skill set allowing us to tackle challenging projects such as long peptides (>100mers), macrocyclics and conjugates.

Almac has two UK-based sites. Our site in Edinburgh, Scotland focuses on high throughput manufacture for non-GMP research use, and our global HQ site in Craigavon, Northern Ireland on cGMP manufacture.

 

Non-GMP custom synthesis

Our high throughput, non-GMP group uses the latest peptide manufacturing methodology and equipment for the rapid custom manufacture of peptides for researchers across the globe. Whether the supply of a single peptide for a one-off experiment, or the manufacture of hundreds of peptides for protein mapping, or a clinical lead generation programme, Almac can deliver. Our service is totally customised and we can manufacture peptides that are linear or cyclised, standard or modified, on the milligram to gram scale.

 

“We’ve been working with this molecule for nearly 15 years, and still Almac taught us things about it we didn’t already know.”

Client testimonial

 

We can incorporate the full range of modifications to your peptide sequence:
• Probes such as biotin or fluorophores
• Cyclised peptides: macrocyclic, side-chain stapling, single or multiple disulphide bridges
• Post-translational modifications such as methylations, phosphorylation and glycosylation

Even in the simplest of projects, Almac will keep the client aware of progress in the manufacture, as well as delivery, so that the client can effectively plan experiments.

Conjugation expertise

Almac has a long standing interest, and over 15 years’ experience, in the art of conjugation. Increasingly, chemistry is called upon to join peptides to proteins or other moieties such as fatty acids or PEGs in order to impart favourable qualities such as stability, receptor targeting or half-life extension. In particular, we enjoy a successful collaboration with Albumedix in conjugation of peptides with albumin through their VeltisR platform.

Almac has experience in a wide variety of conjugation chemistries to ensure control and selectivity:
• Thiol – maleimide
• Thiol – bromoalkyl
• Thiol – thioester (native chemical ligation)
• Amine – NHS
• Alkyne – azide (“click” chemistry)
• Aminooxy – aldehyde
• Hydrazide – aldehyde

Specialist catalogue reagents

Almac also provides a range of specialist catalogue products for use in basic research. These reagents are available from stock and shipped within 24 hours of ordering.
 

Chemokines (wild type, biotin, AlexaFluor® 647 labelled):

Chemokines are a family of cytokines comprising 70-80 amino acids, and containing two or more disulphide bridges. They are involved with immune responses and implicated with a range of therapeutic areas such as inflammation, oncology and anti-virals.

 

Histones: This family of proteins are 120-150 amino acids in length, with high degrees of post translational modifications including Lys/Arg methylations and Ser phosphorylations. Histones are involved with packaging DNA into structural units (nucleozomes), and the reagents are used to investigate wide ranging enzymatic activity.

Ubiquitins: Ubiquitin binds to a range of substrate proteins to mark them for degradation or affect their activity through surface Lys or Cys residues. We have a range of ubiquitylated substrates to act as probes investigating enzymatic pathways.

Almac has over 60 wild type and modified chemokines, 20 histone and ubiquitin reagents available from stock, and is also able to provide custom synthesis of bespoke reagents.

 

GMP peptide manufacture

Almac has been manufacturing GMP peptides since 2007, and has a strong reputation for expertise and service delivery. Our client base is derived across the academic, biotech and pharma sectors through Europe, North America and Asia. All our cGMP projects benefit from support from our experienced project management, analytical and quality assurance functions.

 

First in human

We have manufactured numerous peptide drug substances for First in Human trials. The package provided can be tailored according to the experiences and needs of the client. Whatever the content, the aim of the package is to ensure that material is provided for the first patients quickly, and under cGMP control. We ensure robust process development techniques are used to define an appropriate manufacturing process for each peptide and we are experienced in defining new processes, or in transferring in existing processes. We have helped multiple SME clients who have since licensed their projects to large pharma, with Almac continuing supply.

 

Peptide vaccine cocktails

An increasingly popular approach is to use multiple peptides in therapeutic vaccines in fields such as oncology and anti-allergy. Such approaches involve the manufacture of multiple peptide drug substances which are combined in a drug product cocktail for use as a vaccine. Cocktails present multiple technical and logistical challenges which Almac is experienced in overcoming through the delivery of multiple projects.

 

Late phase and commercial

Almac is also experienced at delivering late phase clinical programs towards commercial manufacture. Here the focus is in ensuring a strong understanding of the parameters influencing variation within a manufacturing process and in delivering cost of goods targets. We follow industry guidelines on process validation, utilising modern Quality by Design methods. The key here is to build a full understanding of the manufacturing process, analytical methods, facilities qualification and cleaning procedures. We achieve this through our bespoke Process Validation Roadmap.

 

NeoPeptidesTM

NeoPeptidesTM are peptides which originate from tumour derived mutations (neoantigens) and are manufactured for incorporation into personalised cancer vaccines. The field of personalised cancer vaccines requires a new manufacturing paradigm to ensure rapid, high throughput manufacture of multiple NeoPeptidesTM to the appropriate quality and regulatory standards required for a clinical setting. The manufacturing methods and quality system required vary greatly from conventional API manufacture, and Almac has for several years been tailoring process accordingly. We have used our years of experience in the field to define robust manufacturing methods designed specifically for the manufacture of NeoPeptidesTM. Such methods have been implemented in the manufacture of multiple patient sets for use in clinical trials. More recently, an entirely bespoke quality system has been written to support our newly constructed dedicated GMP facility for NeoPeptideTM manufacture. The requirements for each client are different, and Almac has experience of operating within a wide range of parameters. We can also provide support for IND application and have experience of supporting sponsor submissions to a range of regulatory authorities across the globe.

 

Why choose Almac for peptides?

Almac has developed a reputation for sound technical capability and excellent customer relations skills. We achieve these capabilities through structured knowledge management and a culturally embedded project management philosophy bringing together multidisciplinary teams for drug substance manufacturing programmes. Our highly motivated teams work tirelessly to deliver projects to customer requirements.

 

“We found the methodology Almac used to transferthe process to their facility was really well structured. We’ve started to use the same approach for our internal projects.”

Client testimonial