Ask the Expert
Q & A: The Benefits of Peptide Outsourcing
These days, companies as small as start-up biotechs and as large as the pharmaceutical and biopharmaceutical majors are
facing increasing pressure to reduce cost, risk, and time-to-market, while maximizing efficiencies. Many have converged
on a similar strategy: outsource non-core functions. Gary Hu, VP, Sales & Marketing, American Peptide Company shares his
thoughts on this topic.
Why outsource?
GH: Whether a company needs research-grade materials or GMP-grade materials, they are realizing cost effectiveness and efficiency by outsourcing peptide production. Outsourcing makes sense, allowing companies to benefit from a service-provider's experience and avoid making costly investments in equipment and training.
Also, peptide manufacturing can be complicated, as tiny variations in processes, reagents, and reaction conditions can produce large changes in the end product's quality, stability and consistency – compromising the ability to meet regulatory standards. Maintaining consistent production protocol requires a level of skill and equipment which in-house manufacturers may need addityionally.
Keep in mind that specialized CMOs often offer a range of services from process development all the way through commercial scale-up, and can be valuable partners in helping to speed a product to market.
PW: Are there any advantages associated with regulatory support in working with a CMO?
GH: It's a good question. Regulatory support is certainly important to consider for companies looking to outsource part of
their manufacturing. It's no secret that regulatory demands are increasing for pharmaceutical manufacturers. As experts in
peptide manufacturing, CMOs have staff specifically dedicated to keeping up-to-date on regulatory changes that pertain
to peptide manufacturing, both domestically and internationally. Dedicated personnel ensure that manufacturing
facilities remain compliant with current GMPs. CMOs also often maintain relationships with regulators and can better
guide customers through the complex and often-changing regulatory landscape.
PW: Does outsourcing pose a risk with supply chain management given that this is yet another big concern for companies considering outsourcing pros and cons?
GH: The truth is that companies can actually improve the security of existing supply chains by turning to CMOs, who often have existing relationships with reliable and qualified suppliers.
Also, outsourcing saves companies time and money they would otherwise spend tracking down needed materials, then authenticating, analyzing, and validating them. These latter functions have become particularly burdensome since the requirement for supplier audits and regulatory documentation has increased with more scrutiny of the supply-chain.
PW: To outsource or not to outsource-- what should be the deciding factor for companies?
GH: While there are several benefits to the outsourcing of peptide production, these benefits are contingent upon finding
the right outsourcing partner. Companies are at-risk in handing off important manufacturing projects, since they are
largely at the mercy of an outside contractor. Therefore, it is necessary for companies to perform in-depth research to
reassure themselves of the suitability and reliability of a CMO partner before committing to a business agreement.
PW: What essential points should a company keep in mind when entering into a partnership with a CMO?
GH: In partnering with a CMO, companies should ensure that the vendor has the appropriate manufacturing and analytical equipment for their project and that the equipment is well maintained.
The chosen CMO must have adequate capacity to handle the project and have enough capacity for downstream projections. Customer must ensure that the production process in use at the CMO's manufacturing facility will produce high-quality products with good yields. Inadequacies in the facility will create inevitable delays and may compromise the product's integrity. CMOs should be able to provide a customer with good analytical methods for the product. Each product should come with a certificate of analysis (COA) with required QC results.
Companies must also consider a CMO's quality system. This includes process analytical technologies that monitor the disposition of materials as they move through the manufacturing process and systems that implement corrective actions and preventive actions (CAPA). Companies should also inquire about CMO's validation procedures and protocols, as well as the mechanism for recording changes in standard operating procedures (SOPs) and systems to capture and analyze data. They must know how the CMO chooses, audits, and validates its suppliers and must inquire about the CMO's contingency plans for alternate suppliers in the event that a primary supplier faces shortages or has difficulty providing ingredients and/or consumables.
PW: It seems like companies looking to outsource peptide manufacturing must do their homework. Is there a way to go about investigating a potential CMO?
GH: Much of the needed information is already in the public domain. For example, a company would need to know whether the CMO being considered has received any FDA-483 Observation and Warning Letter citations in the recent past. Letters are issued by the FDA if it comes to light that inadequacies exist in the quality of equipment, supplies or procedures. Citations may also be issued if a CMO is not following approved procedures or is not sufficiently documenting its activity enough for the FDA to make a determination about its levels of compliance. Companies must make sure that the potential CMOs are conforming to USP, ICH, and other domestic and international regulatory standards.
Additionally, potential customers must investigate the fiscal background of any potential outsourcing partner. A fiscally imperiled CMO may be slow in paying suppliers or may be understaffed, creating unnecessary delays in production. A financially insecure CMO may be tempted to cut corners on quality and services, which potentially compromise the quality of the company's products. In that same vein, companies must also take time to investigate that the CMO's suppliers are capable of meeting financial obligations.
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