Pfanstiehl Custom Active Pharmaceutical Ingredient Manufacturing Services

With a long successful track record in custom Active Pharmaceutical Ingredient (API) manufacturing, Pfanstiehl has established itself as a trusted partner committed to delivering solutions tailored to the unique needs of our clients. Our history is rich with innovation and excellence, spanning decades of experience in supporting the pharmaceutical industry. At Pfanstiehl, we understand the critical importance of fostering strong partnerships and ensuring customer satisfaction at every stage of the manufacturing process. From product inception to on-market supply, we are dedicated to providing comprehensive support that exceeds expectations.

When you partner with Pfanstiehl for custom API manufacturing, you work side-by-side with our seasoned scientists with extensive expertise in chemistry and a track record of success in supporting various stages of clinical development programs and commercial-scale manufacturing.

Pfanstiehl’s Custom API Development and Manufacturing services encompass a wide range of capabilities tailored to meet your specific needs:

Early- and Late-phase Clinical Support:

Our scientists provide comprehensive support throughout early- and late-phase clinical development programs, ensuring seamless progression from preclinical studies to clinical trials.

Multistep Chemical Synthesis:

We excel in both traditional and complex API manufacturing, utilizing cutting-edge capabilities to execute multistep chemical synthesis processes.

Scale Flexibility:

From lab-scale to kilo-scale and pilot-scale manufacturing, we continuously refine & optimize our processes while supplying a wide range of quantities through all phases of development.

Commercial Manufacturing Support:

From product launch to on-market supply, Pfanstiehl is committed to supporting commercial manufacturing needs. With current capacities, we can produce quantities up to 70KG. Pfanstiehl will ensure consistent and reliable supply to meet market demand.

cGMP Compliance:

Pfanstiehl’s operations adhere strictly to cGMP standards, reflecting an unwavering commitment to quality and regulatory compliance. Our proven track record demonstrates our dedication to maintaining the highest standards of manufacturing excellence.

Scale-up Expertise:

Our team offers comprehensive scale-up capabilities, supported by a full range of analytical services. We prioritize flexibility, ensuring timely execution with exceptional yields and superior quality at every stage of the scale-up process.

Development to Commercialization:

Leveraging our extensive commercial API manufacturing capabilities, we guide your project seamlessly from development to scale-up and commercial production. Our integrated approach streamlines the transition, minimizing risk and accelerating time to market.

Pfanstiehl Custom API Manufacturing Capabilities Overview

Potent API drug manufacturing facility scale: 1 to 70kg
Pilot manufacturing: up to 300 gallon reactors
Full scale (2,000 gallon), explosion-proof facility for processing with flammable solvents
Solvent recovery facility
Time-tested API development process:

- - Process Development, Scale-up, Optimization, & Validation
  - cGMP Documentation
  - Analytical Test Method & Validation
  - ICH Compliant Stability Testing
  - Drug Master File (DMF) Development & Validation

Areas of Special Expertise

Pharmaceutical:

Development and manufacturing of API and HPAPI
Advanced intermediates
Potent / Cytotoxic compounds
Linker-Toxins to support ADC manufacture
Nucleoside chemistry – Generic APIs

Biopharmaceutical:

Carbohydrate Chemistry / Rare and Blocked Sugars
Protein Stabilizers / Parenteral Grade Excipients
Bioprocessing Components
Drug Delivery / Solubilizers
Vaccine Stabilizers
Lyoprotectants

Process Development Highlights:

Rapid chemical process development and route optimization, with an emphasis on SafeBridge process safety
Experience and expertise to overcome process bottlenecks and facilitate process improvements
Process development focus on yields, scalability, safety, limited environmental impact, and economics
Process scale-up and validation support
Small scale SMB development
Lab-scale non-cGMP custom synthesis

Analytical Services Include:

Analytical method development and validation:
- - Assay/release specification development for streamlined multi-compendial release
  - Impurity profiling
  - Structural analysis
  - Endotoxin and Glucan detection method development and validation
  - Elemental impurities quantitation at low ppb levels
  - Nitrosamine concentration, and N-Nitroso-structural impurities, nitrite concentration
  - DNA/RNA/DNase/RNase detection and validation
  - Reference standard qualification
  - Cleaning method development and validation
ICH stability testing and protocol development
Impurity marker characterization
KYPP Program to track and trend analytical quality attributes

Facilities & Equipment

KILO LAB MANUFACTURING

Pfanstiehl has a multipurpose kilo lab containment facility on site including:

- Carlisle glove box synthesis isolator – Hastelloy C filter and contained tray drying
- 100 liter glass reactor in Howorth full containment fume booth
- 100 liter Hastelloy C hydrogenation reactor (50 psi)
- Broad processing temperature range – (-)80ºC to (+)200ºC
- Certified to handle compounds down to 0.10 ug/m³ – SafeBridge Category 4 capable
- Kilo-scale non-cGMP custom synthesis

PILOT AND COMMERCIAL SCALE MANUFACTURING

Pfanstiehl is equipped with:

- Large Scale High Potency Manufacturing – Class 100,000 / SafeBridge Category 1-3 production facility
- Multiple glass-lined 300 gallon reactor trains, with a total primary reactor capacity of 1,500 gallons
- Flexible cGMP plant can produce up to ~100 Kg lots of potent / cytotoxic drugs
- New 0.4 m² Hastelloy C Nutsche filter dryer with containment glove box isolator, as well as a multitude of portable Aurora filters (Hastelloy C and Stainless Steel)
- Contained potent compound milling

By partnering with Pfanstiehl, you gain access to a reliable and experienced partner dedicated to delivering high-quality custom API manufacturing solutions on-time and on-budget.

Questions? Click the Contact Us button below and one of our Technical Support Scientists will be happy to assist.

Delivering on the Promise of Purity

Delivering on the Promise of Purity^TM