secure sample and product storage

gmp manufacturing

aseptic filling services

comprehensive analytical services

drug discovery and formulation development

About Us

Apicius Biotechnologies is a comprehensive contract development and manufacturing organization (CDMO), serving start-up and virtual pharmaceutical and biologic companies in the commercialization of innovative therapies and products. Offering end-to-end continuity for our valued clients, we expand your technical resource capability without increased overhead. Let us help you take your product from the bench to the clinic with unparalleled speed and efficiency.

Apicius offers:

Technology transfer
Formulation development
GMP clinical manufacturing
Aseptic fill and finish
GMP storage of samples and products
Analytical services

Services

Our comprehensive suite of integrated services supports all stages of product development:

Technology Transfer

We form a collaborative cross-functional team to ensure that processes, documentation, and expertise are transferred successfully and timely. Our proven process includes documented control strategies, detailed process flows, and key performance measurement, supporting “one-time / on-time” transfer from your site to ours.

Formulation Development

We can perform full chemical characterization rapidly, evaluating and determining the parameters to arrive at the right formulation for successful delivery of your API. Solubility, dissolution, excipient compatibility, and solid-state analysis can help you optimize existing formulations or new chemical entities.

GMP Manufacturing

Our state-of-the-art facility offers a broad range of processing and manufacturing options to meet your needs. We can offer high-shear / low-shear granulation, drying, propellor mixers, V and bin blenders, dual-layer tablet presses, and homogenizers.

Aseptic Fill & Finish

We offer a complete range of aseptic filling capabilities for liquid and lyophilized vials at both a clinical and commercial scale. We utilize automated and semi-automated vial filling lines with regular visual inspection.

GMP Storage

We offer secure, monitored storage chambers at ambient, refrigerated, and frozen conditions for long-term or short-term storage of your products. We can also arrange for cold chain of custody and custom transportation solutions for sensitive materials.

Analytical Services

Our technical staff has years of experience in advanced analysis and testing procedures, including HPLC, spectrophotometry, and ICH stability. Our facility is fully-equipped with state-of-the-art equipment in modern laboratories that operate in accordance with GMP standards.

Contact Us

Map