July 1, 2020 PAP-Q2-20-RT2-009
Continuous investment and innovation are core elements of Pii’s strategy, helping to ensure the company remains maximally relevant to prospective biopharmaceutical partners by delivering on all commitments. In addition to recruiting the industry’s best talent, Pii seeks avenues for further innovation, continues to build cuttingedge technology assets, and reinforces its existing pharmaceutics know-how to empower scientific advancement, to share knowledge, and to pursue excellence across the entire organization.
Pii continually monitors evolving industry trends and technical innovations to stay ahead of forthcoming challenges and proactively develop solutions and services to overcome potential issues. One major driver of change is the ongoing evolution toward increasingly personalized medicine, which in some instances translates into lower production demands or higher-value products. Processing costly drug substances — which often require further enhancements of containment procedures — increases the requirements for innovation in drug development and formulation. Pii is always investing in people and capabilities. One recent example is an expansion of sterile capabilities, including lyophilization and a new fully robotic filling line for small batch processing, in response to increased demand for sterile product processing.
Formulation expertise will become increasingly critical as new modalities enter commercialization and drug products become even more complex. Pii continues to track industry developments regarding biologics, microbiome therapeutics, and cell and gene therapy, expanding their expertise and capabilities where they can determine the best synergies.
In addition to the flexibility that Pii’s facilities offer customers, such as dedicated production suites, they have been able to adapt standard processing practices to accommodate some very unique programs. The company has a long history of problem-solving and, through close collaboration with customers, continues to innovate to progress product development.
Pii is currently in discussion with several existing and prospective customers to support product development initiatives related to COVID-19, including antiviral therapeutics and vaccines. Thus far, the COVID-19 crisis has not impacted Pii’s regular operations, as we have become adept at working in an increasingly “self-monitored” environment.
We are grateful for the continued efforts and dedication of our employees to ensure uninterrupted supply of medicines to our customers and patients. From the beginning, Pii has been declared an essential business by our local government, allowing us to sustain full operation and employment for our teams. Our employees have worked diligently to assure continuity of supply and to keep all R&D projects on track.
Employee safety remains our number one priority. To help ensure the safety of our employees and partners and to protect supply to patients, we have taken extensive actions — in line with guidelines issued by the U.S. CDC, the WHO, and local authorities where we operate — including re-emphasizing good hygiene practices, severely restricting visitor access to our sites, reorganizing our workflows to maximize social distancing, limiting employees to business-critical travel (where permitted by local government policy), facilitating safer commuting alternatives, and employing remote-working strategies.
We continue to survey deep into our supply chain and have not identified any significant risk, delay, or concern that may have a substantial effect on delivery of any product or clinical trial supplies. Our operations, procurement, business development, and project management professionals are dedicated to maintaining business as usual and ensuring any potential delays are mitigated. We wish to express our thanks to all our customers and partners for your trust, collaboration, and support.
Nice Insight, established in 2010, is the research division of That’s Nice, A Science Agency, providing data and analysis from proprietary annual surveys, custom primary qualitative and quantitative research as well as extensive secondary research. Current annual surveys include The Nice Insight Contract Development & Manufacturing (CDMO/CMO), Survey The Nice Insight Contract Research - Preclinical and Clinical (CRO) Survey, The Nice Insight Pharmaceutical Equipment Survey, and The Nice Insight Pharmaceutical Excipients Survey.
Pharmaceutics International, Inc., (Pii) is a premier CDMO, offering unparalleled scientific insight and depth of product knowledge, while supplying high-quality dosage forms that enhance the lives of patients worldwide. Pii provides customized and flexible solutions across several dosage forms and has experience with a broad range of compounds. For 25 years, Pii has been supporting its pharmaceutical partners (from virtual to multinational) with extensive technical capabilities, know-how, and the highest level of customer service. With more than 400 development programs completed, Pii’s scientific team has extensive experience working with drug substances representing a range of physicochemical characteristics (and challenges). Pii’s specialized capabilities, multiproduct facilities, and in-depth knowledge allow them to work with potent compounds and hormones, develop complex dosage forms, and support varied manufacturing processes.