Boston
Advances small-molecule, biologics, and gene-therapy candidates from early pre-formulation through clinical phases. Previously known as Wolfe Labs.
Location: 19 Presidential Way, Woburn, MA 01801
Function: CDMO
Lab size: 22,000 ft²
Certifications / Registrations: GLP compliant
Services:
- Pre-formulation characterization of novel molecules
- Formulation development
- Full analytical support
- Tox supplies
- Lyophilization process development
Ann Arbor
Supports liquid and topical drug products from formulation development through non-sterile clinical supply manufacturing. Previously known as Velesco pharma.
Location: 28036 Oakland Oaks Ct., Wixom, MI 48393
Function: CDMO
Lab size: 16,000 ft²
Certifications / Registrations: GMP manufacturing facility
Services:
- Formulation development
- Analytical development
- Non-sterile clinical supply manufacturing
- Liquid-in-capsule filling
Oakdale
Provides FDA-registered contract research and manufacturing support for small molecules, biologics, and gene therapies. Founded as the original Pace® Life Sciences laboratory, then later expanded through the acquisition of P3 Scientific, Inc.
Location: 1311 Helmo Avenue North, Oakdale, MN 55128
Function: CRO
Lab size: 60,000 ft²
Certifications / Registrations: FDA-registered; DEA-registered
Services:
- Raw materials clearance programs
- Methods development and validation
- In-process and finished product release testing
- ICH stability programs
- Reference standards programs
- Extractables and leachables
- Full microbiology laboratory support (sterile and non-sterile product support)
Research Triangle Park
Provides FDA-registered CRO laboratory support for life sciences clients, from the Research Triangle Park area. Previously operated by Catalent.
Location: 160 N Pharma Drive, Morrisville, NC 27560
Function: CRO
Lab size: 63,000 ft2
Certifications / Registrations: GMP-aligned laboratory practices, FDA-registered; DEA-registered
Services:
- CRO laboratory services
- Life sciences laboratory support
Salem
Sterile Fill-finish Center of Excellence. Delivers clinical manufacturing, including sterile fill-finish, and clinical packaging and kitting, from a GMP facility in NH. Previously known as Bio-Concept Laboratories.
Location: 13 Industrial Way, Salem, NH 03079
Function: CDMO
Lab size: 30,000 ft²
Certifications / Registrations: GMP-compliant; aseptic processing capability
Services:
- Formulation development
- Process development
- Full analytical support
- Aseptic manufacturing for ophthalmic, otic and injectable products
- Toxicology-enabling materials
- Phase 1 and Phase 2 clinical trial materials
- Niche commercial manufacturing
Lebanon
Supports small- and large-molecule analytical services, formulation development and early-stage drug product manufacturing. Previously known as Whitehouse Analytical Laboratories and operated by Curia.
Location: 291 US Highway 22, Lebanon, NJ 08833
Function: CRO
Lab size: 40,000 ft²
Certifications / Registrations: GMP analytical laboratory, FDA-registered; DEA-registered
Services:
- Small- and large-molecule analytical services
- Formulation development
- Early-stage drug product manufacturing
- Analytical chemistry
- Microbiology
- Container closure integrity testing (CCIT)
- Sterility
- Packaging and delivery testing
Philadelphia
Delivers small-molecule formulation, preclinical and clinical manufacturing from a GMP clinical facility. Previously known as Emerson Resources, Inc.
Location: 600 Markley St., Norristown, PA 19401
Function: CDMO
Lab size: 33,000 ft²
Certifications / Registrations: GMP-certified; licensed for controlled substances
Services:
- Small-molecule formulation development and preclinical support
- Clinical manufacturing (tox supplies and Phase I/II clinical supplies)
- Tablets, capsules, liquids, suspensions, topical creams, gels and ointments
- Full analytical support
- Controlled substances and potent compounds
- Solvent processing
- Solubility enhancement (spray-drying, nano-suspensions, hot-melt extrusion)
- Drug product release and ICH stability studies
San Germán
Provides FDA- and DEA-registered analytical laboratory and manufacturing support services for pharmaceutical and medical device clients in Puerto Rico.
Location: San German, San German, PR 966
Function: CRO
Lab size: 22,000 ft²
Certifications / Registrations: FDA-registered; DEA-registered
Services:
- Chemistry and microbiology laboratories
- Raw materials clearance programs
- In-process and finished product testing
- ICH stability programs
- Facility and environmental monitoring programs
- Cleaning verification and disinfectant efficacy studies
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