The startup operates a contract manufacturing organization that specializes in aseptic fill and finish services for injectable drugs, utilizing unidirectional process flows and electronic batch records. This ensures that pharmaceutical companies can produce medical products in a controlled and sterile environment, minimizing contamination risks.
Funding
$82.1M raised to dateRaised to date based on public sources. This may differ from the amount the company actually raised and is based only on what is publicly available on the internet.
Founders
Product
Problem
Pharmaceutical companies face challenges in ensuring the sterile manufacturing of injectable drugs due to capacity constraints, contamination risks, and stringent regulatory requirements. These challenges can lead to production bottlenecks and potential product shortages.
Solution
Selkirk Pharma is a contract manufacturing organization (CMO) specializing in aseptic fill and finish services for injectable drugs. The company offers sterile fill/finish manufacturing of injectable drug products, utilizing unidirectional process flows, best-in-class equipment, and Pharma 4.0 enabled IT and OT infrastructure. Selkirk Pharma's services encompass compounding through product release, including analytical testing and supply chain support. The company's facility is designed for rapid and flexible expansion, offering capacity for liquid-filled vials ranging from 0.5mL to 50mL, with fill speeds up to 3,600 vials per hour and consistent high-yield filling.
Target Audience
Selkirk Pharma serves pharmaceutical companies requiring sterile fill/finish manufacturing for injectable drugs, including those developing clinical trial materials and commercial products.
Features
- High-yield Bausch + Ströbel VarioSys® fill line with line losses as low as 100mL and filled container yields of >99%.
- SKAN isolator technology with integrated skanfog® flow system for rapid and complete sterilization.
- 100% manual visual product inspection in compliance with USP 790 guidelines.
- In-house analytical and microbiological testing using equipment qualified to 21 CFR part 11 standards.
- ClinFAST™ program to accelerate fill/finish manufacturing for clinical trial materials.
- Unidirectional personnel and product flows to minimize contamination.
- cGMP validated, temperature-controlled storage.
- Regulatory support for CMC and product lifecycle in global markets.