ABL's scientific and cGMP manufacturing staff work in a three-way partnership with the client. A staff of PhDs possessing decades of scientific knowledge specific for each critical process step oversee process optimization and product development with a keen awareness of implications for scale-up to cGMP requirements. Prior to the start of cGMP production, the scientific staff transition the process to cGMP manufacturing staff and QC in a collaborative partnership, which includes batch record generation and review and establishment of product specifications. Scientific staff continues to be involved by participating in all weekly project team meetings and monitoring results of critical phases for each production campaign. This collaboration offers the client a well-transitioned process to meet client final product recovery expectations at a maximum savings in cost and time.
Many contract manufacturers focus on large-scale production and have less focus on the early stage clinical trials. ABL's sole focus and expertise is customers with small scale manufacturing needs for Phase I/II clinical trials.
ABL's clients include government agencies, academic investigators, biotech and pharmaceutical companies. This wide diversity in clients shows that ABL is flexible in meeting customers' demands. Repeat customers are our largest revenue generator for contract manufacturing.
Is this your Organization? Request Access
Locations
ABL
5510 Nicholson Lane
Kensington,
MD 20895
United States,
North America
GMP Experience
ABL has successfully completed many varying efforts from process development to clinical manufacturing. Some examples of our past projects would include an HIV-1 vaccine that ABL conceived, designed,