Project management and QA expertise is critical to support manufacture of GMP batches for clinical trials.
We have the expertise to support drug manufacturing and quality assurance activities required to take your product from pilot scale of the API to preparation to GMP batches of drug product for your clinical trial. We integrate these activities into the overall Strategic Development Plan at the appropriate stage. You don’t want to be spending money earlier than necessary, but you also don’t want manufacturing to be lagging behind when you are ready to enter the clinic!
To move your drug from pilot scale to GMP batches you need an experienced team.
B4D has provided project management support for GMP manufacturing of API and drug products and associated analytical testing. We have worked with biologics, targeted therapies, peptides, drug conjugates, small molecules, cellular therapies and new formulations of existing drugs including oral, parenteral and topical.
B4D connects to a network of QA experts to bring in the right experts at the right time, based on the needs of the product. B4D has successfully developed quality systems for a number of early stage companies to ensure GMP compliance.
TRACK RECORD OF SUCCESS
We have a proven track record of successful regulatory filings for drug manufacturing projects we have managed. We have an in-depth understanding of what needs to be done to support and IND/CTA submissions and the experience to save our clients from expenditures that can wait until a later stage in the drug development process.
Service 3: Drug
Early stage companies may not have the QA systems in place needed to meet GMP requirements. We work with you to develop a complete set of SOPs tailored to your company to ensure regulatory compliance as the project moves forward.
Finding the right manufacturing contract manufacturing organization (CMO) for the project is key. The process starts with obtaining proposals from the most suitable CMOs based on experience and reputation – pricing is not the only consideration.
Initial supplier qualification can be based on self-assessments by the CMOs but we ensure that Quality agreements are established and site audits are performed prior to GMP manufacture.
B4D has the experience to manage issues that inevitably arise along the way. We work with chemistry, manufacturing and analytical experts and quality consultants to oversee work conducted at CMOs. Our team provides cross-functional project management support using online collaboration tools for timelines and virtual meetings to keep on top of action items and minimize delays.
We establish virtual data rooms and tracking systems for the numerous project-associated controlled documents – including analytical protocols, reports, SOPs, specifications, certificates of analysis, tech transfer reports, master batch records for engineering and GMP runs, and stability protocols and reports. We also provide critical quality input and expert reviews into these documents as needed.