A client sought Aptuit’s expertise to develop and validate to the NDA level an improved test for quantifying residual host cell DNA (Escherichia coli; E. coli) for release of the drug substance. The existing assay was not as sensitive as requested by the regulatory agency. Furthermore, the timelines required to develop and validate this assay to the NDA level were very aggressive as the product was already on the market.

A small Italian pharmaceutical company that is now part of a larger European entity sought Aptuit’s assistance in the development of a drug product treating inflammatory and auto immune diseases. Because of the low solubility of the API, the client was looking to identify a formulation with improved bioavailability. The decision to work with Aptuit was enhanced

Aptuit has successfully completed several anti-sense oligonucleotides projects in various phases of clinical studies for three pharmaceutical companies. These projects required method development, phase appropriate validation and longterm stability studies of their drug substances and drug products, and testing of the in-process samples.

Aptuit has extensive experience in analyzing large molecules such as proteins, peptid....  Read More

Since 2008, Exelixis and Aptuit have been engaged in a long term strategic partnership that represents a new paradigm in pharmaceutical relationships. From the beginning, Aptuit has brought to the relationship a real understanding of Exelixis’ goal to redefine the way cancer drugs are discovered and developed, fundamentally changing the way cancer patients are treated.

A client sought Aptuit's expertise to improve an existing bioassay for assessing the potency of the client’s biopharmaceutical therapeutic molecule. The existing bioassay was not as precise, accurate, robust and rapid as required. Assessment and quantification of potency for biopharmaceutical moieties is generally done using cell-based or in vitro bioassays. When deriving potency values for a given test sample, in a bioassay, a full d....  Read More

Now part of a larger pharmaceutical entity, a European company engaged Aptuit in the development of a Phase I oncology study focused on capsule formulation of a cytostatic highly potent compound. The project was designed to improve the bioavailability of an immediate release capsule.

The client, a multinational pharmaceutical company, embarked on the world’s largest vaccination study to date. The study was focused on the distribution of 180,000 active vaccine and placebo units to 85,000 subjects at their homes or at clinic sites, situated in five regions in The Netherlands

A midsize pharmaceutical company came to Aptuit to work through the complexities of exporting a controlled substance manufactured in the United States and an EU-sourced comparator for inclusion in a clinical trial across more than 12 EU participating countries. The client required a Phase III, Randomized, Double-Blind, Parallel Group, Placebo and Active Controlled, Dose Optimization Study.

As a drug product enters into the later clinical phases, there is a requirement to support large registration stability studies. A large European client sought Aptuit’s substantial resources to conduct large scale stability testing. Although there are a few other service providers with the capabilities to support large pharmaceutical organizations in these studies, Aptuit offers an added competency because of its large team of dedicat....  Read More

A biopharmaceutical company known for the development of novel therapeutic drugs had a pressing requirement to package a biohazardous frozen drug product. Having worked previously with Aptuit and having experienced excellent results, the client had the confidence to engage Aptuit’s Clinical Packaging and Logistics assistance. The project was conducted at Aptuit’s facility in Allendale, New Jersey