Leveraging tech transfer and analytical capabilities to enter new markets and absorbing additional production steps that brand owners are seeking to offload.
CMO Pharma Tech Industries has grown well beyond its signature powder-based products and recently launched an initiative to help showcase its capabilities in the area of drug delivery devices and concepts. The company restructured its Business Development group, introduced a new ‘plant within a plant’ concept, and unveiled a new bottling line.
Pharmaceutical Processing asked Richard Loughlin, VP of Business Development, what is behind the latest moves, some of the challenges faced today, and where he sees the market headed.
Q: Please describe the CMO environment today for pharmaceutical powders. What are the key challenges faced by CMOs and what is being done to meet those challenges?
Powders are one of the smaller categories of delivery systems used in pharmaceutical products. A few new products are introduced annually in this market in the Rx oral ingestible and inhalation area, but there has not been any significant movement in this market segment.
On the oral OTC and supplement side, innovation has been focused on flavors and packaging, especially unit dose packaging to meet consumer demand for easy-to-carry products. The topical powder market has been flat to eroding in recent years, which has created a need to expand our capabilities, particularly by moving toward more complex drug-device combination products.
Q: Is there any new technology coming on the market soon that could help boost efficiency, lower costs, and improve overall output in servicing customer requirements?
Pharma Tech has installed a high speed bottling line in its Union, MO facility and is in the process of purchasing a high-speed sachet line capable of filling side-by-side sachets for both powder and liquid/semi-solid formulations, as well as fill powders into sachets of unique sizes and shapes. Here, the intent is threefold: to support innovation, meet consumer expectations, and lower production costs.
Q: In general, are CMOs getting any new types of service requests from the pharmaceutical companies today versus five years ago?
The most typical new request nowadays is for reformulation that incorporates new ingredients, flavors, or fragrances. CMOs are expected to provide innovation as well as incorporate other services to absorb additional production steps that brand owners are seeking to offload, including procurement, analytical testing, supplier management, and auditing.
Q: What are some of the key issues and challenges involving tech transfer today, especially in light of increasing attention paid to speed, product quality, and tighter compliance regulations?
Consistency is the biggest key word in tech transfer. It’s crucial to perfect the processes and test methods that ensure content uniformity in support of product label claims. Here’s [how] a CMO becomes an extension and guardian of a product owner’s brand promise.
Q: What’s the best strategy to employ when handling tech transfer and data exchange with a new company for the first time?
Pharma Tech Industries taps dedicated teams to support tech transfer, which serves to place additional emphasis on this vital step as well as separate responsibilities from routine commercial production to include formulation and process optimization. The best strategy is to set project expectations at program initiation and gain agreements on timelines as well as critical dates that need to be met toward the project’s target launch date. It is also critical to communicate frequently to confirm actions and open issues, allowing for elevation or executive consensus when necessary.
Q: Where does Pharma Tech stand in meeting DSCSA rules in time to meet the November deadline?
Pharma Tech is actively engaged in implementing serialization to meet mandated deadlines. Pharma Tech has worked with its equipment and software suppliers to design a flexible and less expensive means of achieving the requirements. Our first product employing serialization technology is expected to be manufactured this June.
Q: What new opportunities are developing today in the supply chain?
Product marketers, who self-manufacture, continue to look at ways to outsource production as the market for powder products remains relatively unchanged and assets can be deployed for other products. This presents new opportunities for existing powder manufacturers.
For example, as more attention is paid to nutraceuticals, this may force marketers of these products to look for manufacturers with more experience and competency in analytical testing. Pharma Tech is leveraging its tech transfer and analytical capabilities to enter new markets by meeting the needs of new product technologies to supplement our core business.
Q: Pharma Tech Industries recently restructured its Business Development unit. What was the thinking behind that strategic move and what’s the primary business goal in doing so?
As there is a need to explore new opportunities to fuel future growth, Pharma Tech has reorganized to bring more depth to the business development process both in increased headcount and diversified background. The objective is to allow for strategic decision making on what technologies and products to target, and also to streamline and focus the early stages of product identification and acquisition.
Q: The company has grown beyond powders into medical devices, packaging components, and cotton swabs. What prompted that diversification?
This has been driven by a combination of factors, including customer requirements and Pharma Tech’s objectives for diversification and a sustainable long-term business model.
Q: A ‘plant within a plant’ concept recently was introduced. Please describe what that is and why it’s important.
To meet the demands of new technology, Pharma Tech is offering its highly successful tech transfer expertise coupled with the dedication of areas of the plant/manufacturing suites/equipment to specific products and technologies. A space is custom designed to meet our client’s manufacturing needs. This space can be dedicated to the client to offer a space that can leverage the cGMP infrastructure of our facilities without the significant cost of building a standalone facility.
Q: Pharma Tech recently announced that it is starting work on a second drug device combination. What type of device is involved and when do you anticipate announcing more about this?
Pharma Tech successfully partnered with a major pharmaceutical company in 2016 to launch a newly approved NDA inhalation product. Pharma Tech is currently engaged in its second activity in this area coupling its tech transfer and manufacturing capabilities with its ‘plant within a plant’ concept. Due to confidentiality, we are unable to provide further detail but will share more on this program when we are able to.
Q: You also recently unveiled a new bottling line. What was behind that move?
The new bottling line is designed to fill high volume ingestible powders at two-three times the speed previously achieved. This provides the benefit of additional capacity and lower cost.
Q: The bottling line was installed in the newly expanded Union, MO facility. Can you tell us a bit about the expansion?
The new building is intended to allow Pharma Tech to focus on new and established ingestible products manufactured in a controlled environment more suitable for the end use of these products. This filling line has outstanding capability and with the increased speed we have capacity available to pursue more programs that require high quality and competitively priced ingestible powders filled in plastic bottles.
Q: What other new areas of growth might be on the radar screen over the next few years?
Drug/device combinations will likely be key, with a focus in the inhalation area. Nutritionals and possibly liquids and semi solids will also play a part. We will also try to leverage our dedicated suite strategy to enter other markets that can leverage our regulatory environment and our entrepreneurial spirit.
About the Company:
Pharma Tech Industries’ cGMP service offerings include manufacturing, packaging, injection molding, technology transfer, project management, process and packaging development, and quality assurance testing covering product platforms such as powders, effervescents, capsules, solid dosage, plastic components, medical devices, and swabs.
Lead image caption: New bottling line installed in November at Pharma Tech Industries’ Union, MO facility.