SAN DIEGO, CALIFORNIA
A Letter from Leadership
Welcome to San Diego!
Our two Clinical Delivery and Supply facilities are located within a 5 minute walk creating a campus feel for early phase manufacturing and packaging. Our Development facility focuses on early phase analytical and formulation development of small molecule and peptide drug candidates from the bench to the clinic and our Clinical facility focuses on primary and secondary packaging as well as logistics and distribution Our Development site offers an array of services that support oral and injectable dosage forms, including pre-formulation testing, analytical and formulation development, and cGMP manufacturing. This facility is the home of our Pharmatek®SD Spraying Drying technology with downstream roller compaction capabilities to support the needs of our clients’ most challenging compounds. Our streamlined processes at San Diego enable a seamless transfer from clinical manufacturing to packaging. We offer blinding and randomization capabilities for packaging in controlled room, refrigerated and frozen packaging suites.
We are committed to providing customized solutions for our customers with a flexible, data-driven approach.
We truly look forward to hosting your visit!
Bryan Knox
General Manager
Brian Avison
Director of Operations
OUR CAPABILITIES INCLUDE:
Development
- Early Phase Drug Development
- High-Potent Handling
- Formulation Development for Oral & Injectable Products
- Analytical Methods Development
- Pre-formulation Testing Compound Selection
- Manufacturing
- Clinical (cGMP): Oral Products
- Non-Clinical: Oral and Injectable
- Bioavailability Enhancement
- Strategies for Poorly Soluble Compounds
- First-In-Human Strategies
- Controlled Release Development
- Stability Testing & Storage
Clinical
- Clinical Primary Packaging
- Clinical Secondary Packaging and Labeling
- In-House Clinical Label Printing
- Clinical Storage and Distribution
- Testing & Storage
- Destructions
OUR TECHNOLOGIES INCLUDE:
Development
- OptiForm®Solution Suite
- Pharmatek®SD Spraying Drying technology
- Particle Size Reduction / Micronization
- Wet, Dry (GerteisMini-Pactor®), and Melt Granulations
- Powder-in-Capsule (Xcelodose®)
Clinical
- Amber packaging
- Refrigerated Packaging and Storage Capacity
- Freezer Storage Capacity
- Primary Packaging: Blistering Line and Bottling
- Secondary Packaging: Kit Assembly, Label Application and Scan verification
- FastChain™ Demand Led Supply
Take a virtual 360° tour of San Diego. Click here to tour our early phase development facility or click here to tour our clinical supply facility.
Click here to take a virtual 360° tour of our San Diego Site.
For more information about our Catalent San Diego site visit our locations page.
Click here for directions to the Catalent San Diego site.
Click here to learn more about Catalent’s vision, mission, and values, as well as our Corporate Responsibility and Diversity & Inclusion strategies.
Visitor Health Statement
Novel Coronavirus (COVID-19)
Catalent is committed to the health and safety of its employees, visitors, and the customers and patients we serve. In light of the Coronavirus outbreak, we have put in place restrictions on access to our sites.
By entering this facility I affirm that:
I have not experienced any of the following symptoms within 72 hours of visiting this site:
- Fever or chills
- Congestion or runny nose
- Cough
- Nausea or vomiting
- Shortness of breath or difficulty breathing
- Diarrhea
- Fatigue
- Headaches
- Muscle or body aches
- New loss of taste or smell
- Sore throat
Catalent takes the health and safety of its employees seriously. As such, if you should exhibit the symptoms of, or test positive for, COVID-19 over the next two days, we request that you contact your Catalent host, so that Catalent can take all possible measures to prevent the spread of the virus.
Site visitor guidelines are dependent on local regulations as well as local pandemic status and are subject to change. Your site host will advise on any changes outside of this document prior to visit.
Key San Diego Site Information
Catalent’s facility in San Diego focuses on early phase development of small molecule and peptide drug candidates from the bench to the clinic. This facility offers an array of services that support oral and injectable dosage forms, including pre-formulation testing, analytical and formulation development, cGMP manufacturing, clinical packaging, labeling, and worldwide distribution. In operation since 1999, this 68,000 sq. ft. facility is conveniently located right in the heart of San Diego’s biotech cluster.
SECURITY
- All Visitors to the facility must ring the bell next to the elevator to check-in at the main lobby on second floor. All Visitors also need to check-in with the receptionist on arrival and departure, and wear the issued visitor name tag or contractor badge at all times while at the facility.
- Please observe speed limits and stop signs while driving on the premises and yield to pedestrians.
- Please park in visitor-designated parking spaces located immediately outside main entrance.
- All vehicles and articles are subject to inspection.
- Taking photographs or videos is not allowed on site.
- Weapons are strictly prohibited on facility property and include privately owned firearms.
SAFETY & EMERGENCY
- Please be aware of displayed warning/personal protection signs and adhere to instructions issued by Catalent staff.
- Do not enter restricted areas or touch any product, materials, machinery controls or equipment, unless authorized to do so by a Catalent Employee.
GOOD MANUFACTURING PRACTICES (GMP)
- The Pharmaceutical facility adheres to regulatory requirements under Federal Law for Good Manufacturing Practices (cGMP).
- Visitors are accompanied at all times within the facility. You will be provided with personal protective gowning requirements relevant to the areas visited during your stay. Jewelry will need to be removed prior to entering GMP Production areas.
- For safety, footwear should be closed toe and with a low heel.
SIGNS & WARNINGS
- Visitors are accompanied at all times within the facility.
- In the event of a fire emergency, a long continuous alarm will sound. Your Catalent Host will escort you to the nearest exit door (fire) or safe location.
ACCIDENT & INJURY
- If you have an accident or feel ill, inform your Host immediately, who will contact EH&S and arrange for medical assistance/first aid.
IT
- Catalent offers wireless internet access for our guests. Please ask your host for instruction on access.
- Catalent provides guest printing services. Please contact reception for instructions at Ext. 2211.