Clinical Trial Manufacturing for Injectable Drug Products

We prepare the required materials in accordance with the Process Development Specification (PDS) jointly defined with our customers, so that the downstream steps — thawing, compounding, filling, visual inspection and, where applicable, lyophilization — can be accomplished as intended.

For early clinical runs filled in our clinical oder development sites, we use 100% single use product contact materials to support speed and flexibility.

Advance with confidence through end‑to‑end cGMP analytics that support every clinical fill‑finish step—backed by structured method transfer, in‑process studies, and highly experienced laboratories.

• Method transfer: Structured method transfers and analytical laboratory qualification (aligned with USP <1010>, <1224>, <1226>); 
  In-process control, ID and release testing: Built on scientifically based sample planning with defined specifications/acceptance criteria. Analytical samples are taken throughout the manufacturing process from early clinical development to commercial.
• Development support: Non-GMP/GMP studies (filtration, pump & fill accuracy, lyophilization cycles, siliconization; physico-chemical methods and particulate matter), along stability sample storage & analysis, backed by specialized, state of the art analytical laboratories.
• Stability: We develop customized stability studies, programs for you. We continuously evaluate data to protect product integrity, support regulatory submissions, and global distribution. Our stability program spans analytical laboratory trials, technical, clinical, registration, PPQ, and commercial batches; Stability storage chambers are ICH‑aligned with continuous monitoring and backups.

We manage the full process: stability program setup, sampling storage, analytical testing, reporting, and link results to primary and secondary packaging material selection and process optimization.

Compounding scales from sub‑liter volumes up to 200 L in a modular setup—glass bottles with stir bars at small scale and polymer/bag systems with integrated impellers at larger scale.

We work with disposable bags or glassware, support a range of aseptic and open connection types, and offer multiple filter options. All product-contact parts are single-use, eliminating the need for product-specific vessel procurement and cleaning validation, and accelerating the setup process.

Choosing the wrong filter can cause holdup volume that can affect yield. Thus, we offer a range of filter options and size/ select membranes and housings deliberately to minimize hold up and conserve scarce drug substance.

Technical filling runs focus on Process Performance Qualification (PPQ) and de‑risk your clinical program by confirming the process design before cGMP clinical manufacture.

• Define and verify process parameters and tailor the Process Development Specification (PDS).
• Generate material for method validation and method transfers.
• Refine risk assessments and finalize master batch records (MBR).

Where possible or required (e.g. for lyophilization), technical runs can be performed with smaller amounts of API, placebo, or surrogates.

Deliver cGMP clinical trial material from first‑in‑human (FIH) through Phase 3 scale‑up using high‑quality, reliable filling processes—supported by holistic analytical services and smooth tech transfer between early‑ and late‑stage sites.

• Scope: Comprehensive cGMP clinical batch filling from initial batches for in-human trial material to Phase 3 scale‑up.
• Quality & yield: Early clinical lines feature RABS for increased process security and 100% non-destructive inline weighing with processes designed to maximize yield.
• Tech transfer & scale‑up: Closely linked sites and an established tech‑transfer concept—with aligned systems and proven scale‑up—enable smooth hand‑offs to late‑clinical and commercial manufacturing.

We develop and optimize lyophilization cycles from laboratory to at‑scale and confirm parameters through technical runs.
Early‑phase execution is supported by qualified vial formats at both our US and EU site.

We execute in‑process, reference, and stability sampling end‑to‑end—from sample planning and analytical samples taken throughout compounding, production, to storage, dispatch to analytical testings, reporting, and study close‑out.

We conduct manual visual inspection of every unit after the early clinical filling process.

We provide SAP‑managed warehousing with qualified conditions (room temperature, 2–8 °C, frozen), and global shipping via air, sea, and temperature‑controlled trucks (incl. cold chain).

Our Known Consignor and AEO‑F certifications streamline secure air freight and customs clearance; slides outline incoming/outgoing requirements for both US and EU clinical sites and sample shipping to Ravensburg.