a) Symbiosis is headquartered in Stirling, Scotland with their operations and manufacturing base located here. Symbiosis also has a North American Sales Office in Cambridge, MA, in the United States. However, Symbiosis has a global footprint, having delivered drug product internationally in 5 different continents and is able to 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.

a) Over the last 10 years, Symbiosis has served 100+ clients across the following industries:
• Emerging and virtual pharma and biotechs
• Established small, mid-sized, and large pharma
• Government lab
• Non-government research organizations
• 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:

• 15-25°C
• 2-8°C
• -20°C
• -80°C

We offer temperature, relative humidity, and where applicable.

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 3 buildings in Stirling’s Innovation Park including a 6,300sq.ft purpose-built GMP sterile manufacturing facility.

Symbiosis operates two clean room suites, each served by a dedicated air handling system. The ‘Containment Suite’, is reserved for the handling of toxic or potent materials that require a high level of containment.  The 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.