List of Contract Manufacturing Companies in Pennsylvania - 12

BioTechnique is a contract manufacturing organization that provides standard and highly-customized cytotoxic and high potency sterile injectable liquid & lyophilized fill-finish services. Our state-of-the-art manufacturing facility is also equipped with a full-scale microbiology lab and offers regulatory affairs, laboratory, and project management support from investigational/clinical all the way through phase IV/commercial. Facility Capabilities: • Sterile injectable manufacturing & packaging for liquid & lyophilized products • Aseptic Vial Filling • Aseptic Lyophilization • Inspection • Formulation • Product Testing • Labeling/Packaging • Stability Storage • Process Design • Full service laboratory • Regulatory affairs support for product filings • Project management Product Capabilities: • Cytotoxics • Highly-Potent Compounds • Monoclonal Antibodies • Antibody Drug Conjugates (ADC) • Suspensions • Inactivated & Attenuated Live Vaccines Filling & Manufacturing Capabilities: • Grade A / ISO 5 Aseptic Filling Suite • 2mL to 100mL vials • 0.2mL to 100mL fill volume • Inline fill volume check weighing • Isolator • 13M2 Lyophilizer • Containment Unloading • Grade A / ISO 5 Capping • Post-Fill / Post-Lyo External Vial Rinse • Single-Use Disposable Manufacturing Train • Vial Inspection & Labeling • ICH Guideline Cold Storage • 2 to 8 ℃ • -20 to -70 ℃ • Stability Chambers & Warehouse Storage • Microbiology & Chemistry Labs

At Endo, our far-reaching vision is simple: to help everyone we serve live their best life. As a specialty pharmaceutical company, we’re motivated by a strong sense of purpose to find better ways to meet unique medical needs. Our global team of passionate employees understands the importance of their work. We’re dedicated to supporting one another as we connect with communities and foster partnerships that elevate quality-of-life and bring the best treatments forward. Our uncompromising commitment results in the delivery of life-enhancing therapies. From intelligent product selection to commercialization, we strive to make a meaningful, tangible impact to help everyone live their best life. Endo has global headquarters in Malvern, Pennsylvania. Community Guidelines: 1. Be respectful. Everyone who visits our page should feel comfortable and respected. 2. If we see a comment that violates anything in the following list, it may be removed. • Comments that use profanity; personally attack or bully another individual; or are off-topic, misleading, factually inaccurate, political, spam, defamatory, discriminatory or promotional. • Comments that are excessively repetitive and/or disruptive to the community. • Comments that promote illegal activity, use copyrights or trademarks or are related to an ongoing legal matter. • Comments that appear to be medical advice. We reserve the right to remove a reply for any reason at any time. 3. Adverse Event Reporting: If we see a post about an adverse event, an Endo representative will need to contact you to find out more information to comply with regulatory guidelines. If you experience a side effect while using an Endo product, please consult your physician or pharmacist immediately. You may also report to the FDA at fda.gov/medwatch or 800-FDA-1088. Replies from other users do not necessarily reflect the views of Endo. We do not endorse content added by other users.

i3 Pharmaceuticals' mission is to develop, manufacture and bring to market high-quality, difficult to formulate, high technological barrier solid oral specialty pharmaceutical products. As a company, i3 Pharmaceuticals' drive for excellence arises from the company's core values: Insight into markets and products, Ingenuity in product selection and development, and Integrity in our partnerships, with an uncompromising dedication to product quality.

IPS-Integrated Project Services, LLC, a Berkshire Hathaway company, is a global leader in developing innovative solutions for the consulting, architecture, engineering, project controls, procurement, construction management, and CQV of technically complex facilities. With technical expertise spanning R&D to pilot-scale to large-scale production, our team specializes in the technology, trends, and regulatory environment to successfully deliver capital projects and improve operations that enable out clients to deliver life-impacting products worldwide. Headquartered in Pennsylvania, IPS is a multinational company with professionals and offices in the United States, Canada, Brazil, the United Kingdom, Ireland, Germany, Denmark, Switzerland, Australia, Singapore, China, and India. With the acquisition of Linesight, IPS has over 3,000 professionals in 45+ offices across 17 countries. Linesight specializes in cost, schedule, risk, program, and project management services in various market sectors, including data centers, life sciences, and high-tech industrial.

Lyophilization Technology, Inc. is a unique Technical Service and Contract Development and Manufacturing Organization. LTI provides comprehensive in-house capabilities ranging from thermal analysis, product design, formulation development, process engineering, streamlining operations, improving compliance, preclinical to Phase II clinical material preparation and technical support for a wide variety of products. LTI has successfully developed formulations, manufacturing processes and prepared material for clinical trials for a wide variety of products. • Anti-infectives • Biologics / Vaccines • Oncolytics / HPCs • Small Molecules / Therapeutics Development Services are conducted with product quality and a manufacturing mindset from the start, considering product administration, stability and processing requirements. Distinct processing areas are comprised of ISO 5 clean rooms directly linked to pilot-scale lyophilizers. Clinical Manufacturing Area (CMA) is flexible for preparation of products with unique requirements, adheres to aggressive project timelines, and is fully cGMP compliant. • Pre-clinical to Phase II Clinical Material • Dedicated / disposable product contact items/equipment • Combined aseptic processing with product containment • Vials 2 to 100 mL and novel delivery systems • US / EU complaint Technical Services The broad range of experience in a wide variety of products provides a specialized expertise from which you can capitalize.

NEXGEL Advanced Hydrogel Solutions in a manufacturer of unique trans-dermal delivery system that was originally developed and FDA-approved for the Hospital Wound Care market, and is now being deployed against Consumer OTC, Rx, Medical Device and Cosmetic applications.

The Lubrizol Corporation, a Berkshire Hathaway company, is a specialty chemical company whose science delivers sustainable solutions to advance mobility, improve wellbeing and enhance modern life. Founded in 1928, Lubrizol owns and operates more than 100 manufacturing facilities, sales and technical offices around the world and has more than 8,000 employees. For more information, visit www.Lubrizol.com.

PCI is your world leading CDMO, providing integrated end-to-end drug development, manufacturing, and packaging solutions to increase product speed to market and opportunities for commercial success. PCI brings the proven experience that comes with more than 90 successful product launches each year and over five decades in the delivery of CDMO services. With 30 sites across Australia, Canada, North America, the UK, and Europe and over 6000+ dedicated employees, together, delivering life changing therapies. Leading technology and continued investment enable us to deliver development to commercialization solutions throughout the product lifecycle, collaborating with our clients to improve the lives of patients globally.

Our mission at Predictive Oncology is to change the landscape of oncology drug discovery and enable the development of more effective therapies in the treatment of cancer. By harnessing the power of machine learning, scientific rigor and biologics, we can improve the probability of success and advance drug compounds with a higher degree of confidence. We invite you to follow us to stay up-to-date about our latest developments.

Sigmapharm Laboratories, LLC, a privately held specialty pharmaceutical company, is engaged in the development, manufacturing and marketing of unique generic and branded products. Our company also provides contract development and manufacturing of patentable, stable and maximally bioavailable formulations of new chemical entities. Our products are developed and manufactured using our proprietary drug delivery systems which can effectively optimize drug solubility, bioavailability and stability. Presently, our company and its affiliates control more than seventy (70) formulation patents worldwide. In addition, we are fully integrated (sometimes referred to as ‘backward integrated').

VintaBio’s development and manufacturing team has over a century of experience in the cell and gene therapy space and its members have played key roles in the development of the most advanced therapies on the market today. Located in the historic Navy Yards of Philadelphia – the epicenter of cell and gene therapy innovation – VintaBio specializes in developing and manufacturing consistent, high-quality viral vectors, a vital and currently underserved area of CGT development. The company was founded by Junwei Sun and Dr. Shangzhen Zhou, who led development of the AAV vectors behind the first two FDA-approved gene therapies, as well as the lentiviral vector for the first FDA-approved cell therapy. VintaBio has raised $64 million in venture funding, which has been used to develop a brand new 22,500 square foot facility in Philadelphia created specifically to facilitate efficient cell and gene therapy manufacturing.

WuXi Advanced Therapies - Accelerating Progress and Time to Market WuXi Advanced Therapies is a cell and gene therapy Contract Testing, Development and Manufacturing Organization (CTDMO) that is reducing the complexities of manufacturing by providing integrated platforms that enable cell and gene therapies to be developed, manufactured, and released faster and with greater predictability. Our Story By leveraging platforms and integrated testing our team provides expedited development and commercialization of cell, gene, protein and viral-based therapies. This approach enables new biopharmaceuticals to be developed, manufactured and released faster and with greater predictability, thereby reducing the complexities of high-touch, multi-vendor production models. Our solutions help clients overcome challenges to commercialization, including process development, manufacturing capacity, analytical development, and raw materials management. Multiple, scale-able, enabling platforms integrate manufacturing, process development and testing capabilities to provide greater predictability and speed to clinic. We support advanced therapy programs with extensive infrastructure and 400,000+ square feet of state-of-the-art, GMP-compliant facilities on our modern campus located at the Navy Yard in Philadelphia, Pennsylvania.