The company announced the expansion last week as the first phase of its ADC and cytotoxic service offerings. According to the company, Process and Analytical Development laboratories will be available for client programs in January 2016.
“ADC facilities must be designed for both aseptic handling and manipulation of biologically active material as well as highly potent payloads,” said Jason Brady,Althea’s Sr. Director and Business Head of ADCs. “This means [having] equipment usually found in a biologics manufacturing facility along with specialized equipment and facility design for safe handling of cytotoxics, all while maintaining a GMP environment.”
The Process Development labs will be equipped to perform services such as bioconjugation, process development and optimization, ultrafiltration and diafiltration process development, as well as ADC material generation using low Occupation Exposure Limit (OEL) payloads for pre-clinical studies.
The Analytical Development labs will support process development services, such as cleaning verification, raw material identification testing, ADC characterization assays, and safety and potency assays.
With the additional services, Althea will be able to combine cytotoxic payload conjugation along will fill finish and lyophilization of the final drug substance. “Thus combining two complicated steps that are often sourced separately,” Brady said.
Additionally, “By limiting the amount of time required to release, package, and ship the ADC to another location for formulation and filling into final form, clients can decrease overall supply chain timelines,” says Brady.
The next phase of the company’s expansion will be completion of the GMP conjugation area, which is expected in Q3 2016, followed by competition of the GMP fill/finish manufacturing area, slated for early Q2 2017.