Issue link: https://www.e-digitaleditions.com/i/1375981
www.biopharminternational.com May 2021 BioPharm International eBook 21 C ol l a b or at ion i s t h e k e y c on- cept that continually pops into my head. If the cont ract manu fact u r- ing relationship isn't col laborative, there l ikely w i l l be problems. For example, I've seen sponsors f ind out about a big change to the produc- tion process, one that would require a supplement to their appl ication, not get escalated in time. Then the decision to stop production (or not) would need to be assessed. BioPharm: Drug companies are u lt imately responsible for product quality. How do you better under- stand what is going on at a CDMO before it is too late? W hat tools / processes can prevent this from hap- pening? Ly n n (RC A ): I f you're a l re a dy in a cont ract ua l relat ionsh ip w it h the CDMO, then oversight of the manufact uring qua lit y is the tool. How t h is is done shou ld b e out- l i ne d i n you r q u a l it y a g re ement . I f it is not , I ' d su g ge st you sta r t the process of amending your qual- it y ag reement as soon as possible. However, in any great relationship one critica l key to success is com- mu n icat ion. I f you wa nt to k now what is going on at your CDMO, pick up t he phone a nd ca l l t hem, reg a rd less of what is spec i f ied in your qualit y agreement. If you are looking for a CDMO, I suggest, at a minimum, following the tools I've discussed in the earlier responses. For example, thorough due diligence audits, setting up a thorough quality agreement and overall collab- oration should be considered in assur- ing the quality of that product you're trying to outsource to a CDMO. Another concept is on the develop- ment side. If your product is going to be transferred from your R&D orga- nization into this CDMO you need to ensure that the technical transfer process is iron-clad. Think, how do we, as the developing organization, ensure that the knowledge is trans- fer red to the CDMO so they can produce this product? LESSONS LEARNED FROM COVID-19 BioPharm: W hat has COV ID-19 taught the industry about the approval of manufacturing facilities/lines by regulators? Partnerships for Outsourcing Quality/Regulations The COVID-19 pandemic has required pharmaceu- tical companies and contract manufacturing orga- nizations (CMOs)/contract development and manu- facturing organizations (CDMO) to quickly work to develop and produce vaccines to prevent COVID-19 and medicines to treat the patients who get sick with the virus. Par t of this process is the regulator y approval of manfucturing lines and facilities used to manufacture these products. How can sponsor companies and contract organizations ensure their facilities are up to standard for the manufacture of COVID-19 and other medicines? CMOs and CDMOs that don't have the capacity to validate dr ug license applic ations for their manufac turing lines will of ten hire consultants to assist in pre-approval inspec tions (PAIs) and pre- licensure inspec tions (PLI), according to Edgar Guer zon, senior managing consultant at Tunnell Consulting. A nd technology tr ans fer from the sponsor company to the CMO/CDMO facilit y is key, says Guerzon. "This site must be designed not only to be able to produce a scaled-up version of that sponsor's produc t, but be versatile enough to accommodate other sponsors' produc t s. The technology-transfer repor t must have ver y explicit documentation, which demonstrates sound, logical, scientific reasoning that when sc aled up, the product will be safe and efficacious to the patient," says Guerzon. To verify that CMOs/CDMOs are following current good manufacturing practices, sponsor companies should perform process mapping and risk analysis, says Guer zon. Failure modes and ef fec t analysis (FMEA) can identif y failure in manufac turing and testing processes, according to Guerzon. "Then you plan to either eliminate the occurrence of failure or minimize its effect. Basically, determine all scenarios where something may go wrong and have a plan to address them. There should be separate FMEAs for process, testing, and equipment; these are live documents and updated as necessary," he says. —Susan Haigney Working with contractors to ensure quality "However, in any great relationship one critical key to success is communication." —Steven Lynn, Regulatory Compliance Associates