Contract Formulation Company Profile - Symyx Technologies Inc.

Symyx Technologies, Inc.
Symyx Technologies, Inc.

Headquarters
Sunnyvale, CA

Location(s)
Santa Clara, CA; Sunnyvale, CA; San Ramon, CA; Iselin, NJ; Bend, OR; Basel, Switzerland; Tokyo, Japan

Years in Drug Formulation
11 Years

Spokesperson
Richard Boehner, president, High Productivity Research (HPR)

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

Types of Drugs
	Generics			Prescription			OTC

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

Company’s role in drug discovery and developmnet
Symyx Technologies enables companies in life sciences to transform scientific R&D and achieve extraordinary breakthroughs in productivity and return on investment through expertise in scientific information management, microscale parallel experimentation, and contract research. When compared with traditional R&D, Symyx helps scientists and researchers lower cost per experiment up to 90 percent; perform 10 to 25 times more experiments per year; decrease the amount of expensive, early-development material required for experiments up to 90 percent; and reduce the amount of time required to acquire and analyze large, comprehensive sets of experimental data from weeks or months to days.

Company’s experience and expertise in drug formulation
Symyx has been involved in drug formulation since it developed a Discovery Tools polymorph system for use in rapidly determining the optimal crystalline forms of drug candidates for Merck in 2001. Since then, the company has developed specialized tools and workflows enabled by its laboratory execution and analysis software to help pharmaceutical companies improve and accelerate their small-molecule formulation development. In early 2008, Symyx launched its Contract Research for Life Sciences, which enabled companies to access the advantages of Symyx microscale, parallel experimentation and advanced informatics on an outsourced basis, by announcing an agreement with Bristol-Myers Squibb to conduct solubility studies. In August of 2008, Symyx acquired Integrity Biosolution and entered large-molecule formulation development with a goal of leveraging its expertise in informatics and automated parallel experimentation to improve the speed and quality of formulation development within the biopharmaceutical market.

Relationship with pharma companies
Symyx is experienced in working with pharma companies through three avenues: licensing of its software and databases (including electronic laboratory notebooks and decision support software), and automated microscale, parallel experimentation workflows equipped with laboratory execution and analysis software, and through outsourced contract formulation development of both chemical and biological formulations. This gives companies the flexibility and agility of in-house or outsourced formulation development while maintaining equally high levels of productivity and quality.

Factors critical for drug formulation
In addition to ensuring the safety and efficacy profiles of proteins and peptides, the integrity of the formulation and its individual components needs to be optimized for clinical, commercial and regulatory needs. In Symyx’s formulation development studies for proteins and peptides, the composition of each excipient is optimized to maximize the stability within the products’ specific requirements. In order to save precious drug substance and expedite the development process, Symyx contract research employs a strategy with its pharma customers of separately developing the clinical and commercial formulations. The preclinical/clinical formulation is developed within a 3-6 month time frame to provide an initial formulation that is stable enough to support the development process up to Phase II clinical trials. The commercial formulation can then be developed or optimized while clinical studies are in progress.

Business/regulatory trends impacting drug formulation
Small-molecule drug candidates are generally becoming larger and more hydrophobic. Thus, the ability to formulate these compounds requires novel approaches and broad screening of possible excipients to ensure a high bioavailability. Symyx’s technology allows for rapid formulation optimization of such challenging compounds in traditional oral-based drug product forms as well as more novel solid dispersion and liposome-based formulations.

Specifically related to large molecule formulation development, stability is not just measured by changes in primary structure but in secondary and tertiary structure changes as well. The result is the need for complex and orthogonal analytical technologies to detect all of the chemical and physical instabilities during formulation development, and hence an automated workflow that must integrate with a substantial number of analytical devices which Symyx’s platform technology can accommodate.

Success story
We collaborate with a wide spectrum of clients ranging from start-up biotech companies to large, well established pharmaceutical companies. We have completed hundreds of contracts, with examples including:

a lyophilized formulation for a therapeutic protein in early clinical trials, featuring stability and reduced injection site reaction
improved purity of a drug substance through optimization of the manufacturing process
a patent-pending formulation of a product in a late stage clinical trial, optimized to improve its stability

Symyx has actively participated in project management for the development of several delivery devices. General business rationale, overviews and presentations of the delivery device market were given to clients which directly influenced their marketing strategies. Detailed brainstorming and product testing sessions were conducted with the internal product development teams. After the device candidates were selected, Symyx facilitated business and technical contact with the device companies to obtain additional information, e.g., timeline for development, business agreements, cost estimates of development, etc. Subsequently, clients have established business partnerships with delivery device companies to develop the most appropriate or ideal device for their respective products.

How will roles of CROs and contract manufacturers change over the next few years?
As it stands today, the standard CRO offering is not differentiated – it’s very much a commodity offering – and over the next few years, that will change. To win over the next 5 CROs are going to have to utilize technology that dramatically improves productivity. Technologies such as microscale, parallel experimentation workflows with integrated informatics will allow customers to access directional information in near real-time as it is collected from the instrumentation.