Symbiosis is headquartered in Stirling, Scotland with their operations and manufacturing base also located here. Symbiosis has a global footprint however, having delivered drug product internationally across all 5 continents and can provide access to the EU for North American clients, leveraging a wealth of experience of distributing to the US for both UK and EU partners.

Since 2011, Symbiosis has served 100+ clients across the following industries:

• Emerging pharma and biotechs
• Established small, mid-sized, and large pharma
• Government labs
• Non-government research organisations
• Academia

Symbiosis has a proven track record of delivering aseptic manufacturing projects across a range of modalities:

• Vaccines
Supporting clinical batches across traditional attenuated or inactivated products to recombinant, viral vector and nucleic acid-based vaccine technologies

• Small Molecules
Symbiosis has provided GMP manufacturing across a wide range of small molecule applications, including highly potent materials requiring specialist handling

• Antibody-Drug Conjugates
Overcome your development and manufacturing challenges with a partner that has the experience and capabilities to handle your highly potent ADC

• RNA and Peptide Therapies
Often have challenging manufacturing and handling requirements that need specialist knowledge and experience

• mAbs and Recombinant Proteins

Extensive experience in delivering hundreds of biological drug projects allowing us to support your clinical trials

• Advanced Therapy Medicinal Product (ATMP) and Viral Vector Therapies
Clinical and small-scale commercial manufacturing of advanced therapeutics such as viral vectors for cell and gene therapies and raw materials such as plasmids

We offer the following temperature storage conditions:

• 5 to 8°C
• -20°C ± 5°C
• -80°C ± 10°C
• 25°C ± 2°C / 60% RH ± 5% RH
• 30°C ± 2°C / 60% RH ± 5% RH
• 40°C ± 2°C / 60% RH ± 5% RH

We also offer:

• Stability study protocol generation and sample management
• Interim testing and final reporting

MHRA Investigational Medicinal Product (IMP) licence for clinical supplies
MHRA Manufacturer’s/importer’s (MIA) licence for commercial supplies
FDA commercial inspection history

Symbiosis operates out of 4 buildings in Stirling, UK . 

Symbiosis operates two clean room suites, each served by a dedicated air handling system. Our containment suite is reserved for the handling of toxic or potent materials that require a high level of containment whilst our conventional suite is dedicated to the handling of conventional NCEs and biological molecules and is at positive pressure relative to atmosphere.

Vial sizes range from 0.5mL to 100mL vials. Vials are either type1 glass or cyclic olefin polymer vials.

• Aqueous based, parenteral aseptic filling
• We have experience from pre-clinical, Phase I, Phase II and Phase III clinical to commercial

Maximum filling run is ~3,000 vials. Minimum is as small as required (considering weight checks, testing and retained requirements).

One of Symbiosis’ main differentiators is the quick access to filling slots. Typically, we can accommodate within 6-8 weeks, depending on the amount of preliminary and set-up work required.

Symbiosis can manage and coordinate all of your analytical and microbial testing requirements. This includes testing of:

• Raw materials
• In-process controls
• Final product release
• Stability studies.

Symbiosis offers bulk label and packaging, vial labelling for identification, clinical trial labelling, blinding, multi-language and multi label. Label designs will be provided by the client and approved by Symbiosis QA before application. Packaging can be performed to client specifications.