Contract Formulation Company Profile - UPM Pharmaceuticals

UPM Pharmaceuticals, Inc.
UPM Pharmaceuticals, Inc.

Headquarters
Baltimore, MD

Location(s)
Baltimore, MD

Years in Drug Formulation
12 Years

Spokesperson
Fran Spaven, VP, Drug Development Services; Gary Hollenbeck, Chief Scientific Officer; and Dean Cirotta, President and COO

https://www.upm-inc.com

Areas of research
	Small Molecule			Biological			Other

Drug Formulation Services Offered
•	Analytical method development		Bioavailability enhancement
•	Compatibility studies of active ingredients	•	Dosage form selection
•	Excipient compatibility	•	Formulation optimization
•	Formulation stress testing		in silico studies
•	Manufacture of clinical supplies		Novel delivery system
	Packaging compatibility assessment		Particle size reduction
	Preclinical studies		Solubilizing water-insoluble drugs
•	Stability studies		Taste masking/flavorings

Other Services Offered
	Disease Research	Target Identification
	Lead Identification	Early Safety Tests
	Lead Optimization	Pre-clinical Studies
	IND Submission	Clinical Trials
	NDA Submission	Post-marketing Studies
	OTHER

Types of Drugs
•	Generics		•	Prescription		•	OTC

Dosage Forms
•	Capsules		Implantable
	Inhalation		Injectible
•	Oral		Parenteral
•	Peptide and Protein	•	Tablets
•	Topical		OTHER

Company’s role in drug discovery and developmnet
Fran Spaven, VP Drug Development Services: UPM has over 12 years experience in solid and liquid dosage formulation development. Working closely in partnership relationship with Clients, UPM understands the importance of scientifically designed experiments and the ability to respond quickly to changing clinical requirements, as well as meeting the clients budgetary and timeline constraints.

Gary Hollenbeck, Chief Scientific Officer: Design, manufacture, and physical-chemical analysis of dosage forms for administration to humans and animals to support all phases of drug development, as well as niche commercial manufacturing.

Company’s experience and expertise in drug formulation
Fran Spaven, VP Drug Development Services: UPM’s expertise spans across liquid, capsule, and tablet dosage formulation development. We have a broad array of small scale processing equipment that allows for processing of mini-batches and early phase clinical supplies, to pilot scale equipment for late phase clinical and small scale commercial manufacturing.

Gary Hollenbeck, Chief Scientific Officer: Immediate and modified release, liquid and solid formulations of both small and large molecules, primarily for oral administration. Full range of expertise and experience with both new chemical entities and approved drugs, ranging from direct API fill in a capsule to modified delivery systems with multiple actives. Successful development of solid dosage forms for: low dose actives, peptides, tablets, and capsules with hygroscopic and moisture sensitive active ingredients.

Relationship with pharma companies
Fran Spaven, VP Drug Development Services: UPM structures the majority of its client relationships on a contractual basis. We seek to give our Client’s the greatest flexibility in utilizing our services by incorporating Go No-go decision points, as well as sectionalized payment installments. In this way Client’s can better balance initiation of a project, while certain parts of the program are still being defined.

Gary Hollenbeck, Chief Scientific Officer: The business relationship is primarily contractual for projects with a defined scope. Project leaders are experienced PhD scientists who direct and manage the UPM project team and oversee communications with the client. The drug formulation process is generally collaborative and iterative; the client provides target product attributes, UPM presents formulation strategies, prototypes are produced, evaluated, and ultimately selected. To the extent possible, compendial excipients and standard processing methods are employed to facilitate scale up and technology transfer.

Factors critical for drug formulation
Fran Spaven, VP Drug Development Services: Early understanding of any challenges of API stability in the dosage form and pharmacokinetic parameters are critical factors in drug formulation. UPM offers mini-batch processing utilizing small amounts of API to obtain proof of concept across multiple formulations. Our scientists utilize modeling and experimental designs to minimize waste that goes along with empirical approaches. Xcelodose, powder in bottle, binary blends for no formulation approaches to quickly get into clinic with just the API.

Gary Hollenbeck, Chief Scientific Officer: From a scientific perspective, critical challenges include overcoming solubility and stability issues for increasingly potent and complex molecules to produce robust, quality products. In early stage development for new chemical entities the attributes of the API may change in significant ways from lot to lot; when this is likely, it is advantageous to employ formulation and process strategies which mitigate the impact of these changes. From a business perspective, it is striking the right balance between scope, time and costs.

Scientific/business/regulatory trends impacting drug formulation
Dean Cirotta, President and COO: As a result of more sophisticated screening and customized processing, many new chemical entities will be more selective and potent. Down stream activities from formulation to testing will need to be able to address the additional challenges of low dose, potent drugs.

Gary Hollenbeck, Chief Scientific Officer: One trend is proof of concept without formulation. Administration of API in a capsule is increasing in popularity, in part because of the emergence of automated micro-balances, such as the Xcelodose we have at UPM, which permit highly accurate filling and a documented weight record of each capsule. The absence of early stage formulation experience is the price paid for this rapid proof of concept.

Dean Cirotta, President and COO: Against the backdrop of the current economic turmoil, big pharma faces eroding patent protection, increased generic competition, and fewer compounds being approved by the FDA. Big pharma is in a position to take advantage of the current credit crunch by snapping up smaller biotechs to bolster their sagging pipelines. Drug companies and contract vendors will need to be able to react quickly to changes brought about with increased industry consolidation.

Gary Hollenbeck, Chief Scientific Officer: Seldom is there enough time, money or API to completely define a response surface, so the key to success is judicious, science-based decision making by experienced pharmaceutical scientists.

Success story
Fran Spaven, VP Drug Development Services: UPM has many success stories, however the ones that really stand out are those that were successful while overcoming multiple challenges. It is not unusual for a client to have an aggressive timeline, or API availability limitations, or budgetary constraints, or a compound with unique formulation challenges. However to have all these challenges at once presents an exceptionally unique situation for any vendor, as was the case for us. UPM initiated a two prong approach with the client utilizing model driven experimental designs and mini-scale equipment to efficiently formulate with a minimum of API. Two teams of scientists worked in parallel so that data and decision points could be communicated and executed immediately.

Gary Hollenbeck, Chief Scientific Officer: Potent peptide for oral administration. The client was experiencing difficulty achieving dose uniformity and the peptide was unstable in encapsulated dosage forms. The peptide was known to have multiple degradation pathways, including hydrolysis and oxidation. Only small quantities of the active were available for both analytical and product development. A stability indicating HPLC method was developed. Potentially stabilizing formulations were processed on mini-scale equipment. The client ultimately was able to establish an intellectual property position to help protect the final product.

How will roles of CROs and contract manufacturers change over the next few years?
Dean Cirotta, President and COO: As companies look for fast, cost effective ways to get drugs to the clinic quickly, many have taken approaches that by-pass formulation such as neat API in a capsule. Contract organizations that have proven formulations, technologies, or processes that facilitate the next stages to commercialization, will be able to provide the most value to development companies.

Gary Hollenbeck, Chief Scientific Officer: Given the cost of new, specialized equipment and the need for highly-trained personnel, I expect fewer “full-service” CRO options for clients. While better quality attributes can be achieved for products developed on specialized equipment, clients will ultimately have more difficulty finding technology transfer options for scale-up and contract manufacturing. This trend will place a premium on the initial development decision.