NCE innovation is changing the supply chain in an unprecedented way. Couple this with a tighter regulatory framework and the payers’ search for more quality and better value and the unprepared might get blown off course, argues Marcel Veltrop, SAI Life Sciences
Pharma innovators are under increasing pressure from regulators, resulting in an increased number of cGMP stages when compared with earlier practice. Severe scrutiny on impurities at all stages, even registered starting materials, is putting a strain on pharma innovators and their suppliers. Parallel to this trend, NCEs coming out of the global discovery pipeline have fundamentally changed in nature, as well as volumes typically being much lower. The molecules themselves have become more complex, requiring both a tailored train of unit operations and extra layers of quality control over the entire process.
Quality, as immutable as it may sound, has to be re-defined and is now the overriding selection criterion applied by global pharma innovators
This has major implications for contract development and manufacturing services providers such as SAI Life Sciences. It means nothing short of a complete redesign and upgrade of every single aspect of the primary process. Quality, as immutable as it may sound, has to be re-defined and is now the overriding selection criterion applied by global pharma innovators, even though cost pressures initially work against the extra controls required. The quality function and awareness within companies needs a renewed effort to move away from the check-box approach to embrace fully the requirement of getting even the smallest of details right and leaving nothing to chance.
Quality at SAI is now becoming a partner, consultant and coach to the primary process functions rather than an internal control function. SAI is changing the way it selects and approves its increasingly long list of raw materials that go into the synthesis of these complex NCEs, and how it develops methods and expands know-how generation on the most optimal process in line with ICH Q11 guidelines.
Cross functional experts of all disciplines now have to work closely together to absorb this increased precision in processes
Cross functional experts of all disciplines now have to work closely together to absorb this increased precision in processes and prepare the right recipes in tailored equipment finally to make products that meet very stringent specifications.
This pharma innovation dilemma requires forward-thinking collaborators at the manufacturer and innovator who work as partners in a joined-up effort with trust at the core of it.
Bottlenecks are emerging in the management of a larger set of smaller but more complex NCEs. This means the skills and abilities of CMOs have to transform from ‘doing exactly as told’ to being able to independently manage and deliver the requirements, trouble shoot and solve the many challenges within the collaboration scope.
Communication skills are often subordinate to hard science in the pharmaceutical industry but they are pivotal in this new working environment. Culture and values underpin effective communication with a larger set of stakeholders in the supply chain.
The last critical element in pharma innovation has become the need for speed.
The last critical element in pharma innovation has become the need for speed. Therapeutic areas have become more narrowly defined, also enabling earlier launches than seen previously. Avoidance of time-intensive tech transfers is achieved by having an integrated lifecycle model that supports this requirement for speed and accuracy.
SAI stays on course by utilising the energy in the system to respond to the changing winds by evolving all facets of its delivery model. At SAI this is called ‘+1’.