PHARMACY MARKET

Cascade Chemistry Initiates $14 Million Expansion of cGMP Pharmaceutical Manufacturing Capacity

Cascade Chemistry | February 19, 2021

Cascade Chemistry Initiates $14 Million Expansion of cGMP Pharmaceutical Manufacturing Capacity
Cascade Chemistry, a main pharmaceutical contract development and manufacturing organization, today declared inception of development of new offices intended to expand the organization's ability to manufacture APIs (dynamic pharmaceutical ingredients) under cGMP (current Good Manufacturing Practices standards and procedures).

The new offices, expected to be operational in the main quarter of 2022, will eventually expand the organization's floor space just about three-overlay and essentially add to its cGMP manufacturing limit and scale. The extension likewise incorporates 2,200 square feet of new insightful labs, a powerful quality framework and extra office space.

“This $14 million expansion reflects our growing success as a reliable, experienced and flexible outsourcing partner with exceptional chemistry problem-solving expertise,” said Jeremiah Marsden, PhD, President of Cascade Chemistry. “Our customers are increasingly requesting our assistance in producing APIs for their clinical trials, and demand has outstripped our cGMP manufacturing capacity. We were fortunate to acquire two suitable buildings just 10 minutes from our current facility, and construction of new cGMP manufacturing suites that will greatly increase our clinical trial API production capacity is now underway.”

The 28,000-square-foot fabricating currently under development will at first incorporate five suites for Phase 1 and Phase 2 cGMP manufacturing with stream hydrogenation and reactors up to 400 liters. Extra limit with respect to API Phase 3 and business scale cGMP manufacturing up to 1,000 liters will be included 2022. The subsequent structure, with 7,000 square feet, is saved for future development.

Dr. Marsden continued, “We ultimately will expand into the second new building to build further cGMP capacity for commercial-stage low-volume, high-value pharmaceuticals. We are grateful for the support from our customers that is driving this expansion, as well as our employees’ dedication to excellence and their creativity and hard work that make it all possible.”

About Cascade Chemistry
Cascade Chemistry specializes in active pharmaceutical ingredient (API) process development, scale-up and cGMP (current Good Manufacturing Practices) manufacturing. Most of our chemists have advanced degrees and are capable of crafting process solutions tailored to the specific needs of our clients, while adhering to strict FDA quality standards. We offer cost effective and rapid solutions for the development and manufacturing of API cGMP batches at 1-10 kg scale, and we will begin offering greater capacity at our new facility in 2022. It has been our philosophy for almost 40 years that quality is a key component of successful cGMP manufacturing. We view quality as a guiding principle, achieved by rigorous due diligence at each step of the development and manufacturing process. Cascade Chemistry is headquartered in Eugene, Oregon.

Spotlight

Regulations allowing compassionate use of investigational drugs have been in effect since 1987, when public anger about the slow pace of approvals for HIV/AIDS drugs resulted in rules allowing greater access to drugs in development. Last year, the FDA updated its rule to expand the patient categories that may have rights to use unapproved drugs and to clarify requirements for expanded-access programs. The old system allowed individual patients access to investigational drugs through an emergency IND system, while large groups received access through treatment protocols. Under the new rule, the FDA allows access to unapproved drugs on a case-by-case basis for single patients, small groups of patients with similar treatment needs and even larger groups of 100 patients or more. In addition, the term “serious illness” has been redefined to include a much broader array of conditions.

Related News

Medicure Announces Termination of ReDS™ Pro Marketing and Distribution Agreement

Prnewswire | August 20, 2020

Medicure Inc. a pharmaceutical company, today announced the termination of the marketing and distribution agreement with Sensible Medical Innovations Inc. ("Sensible") for the marketing of the ReDSTM Pro ("ReDS Pro") device in the United States. In connection with the termination, Sensible and the Company have entered into a transition agreement which provides additional compensation to Medicure for sales to customer leads provided by Medicure. Medicure continues to hold a 7.71% equity stake, on a fully diluted basis, in Sensible Medical Innovations Ltd. ("Sensible Medical"), the parent company of Sensible. Medicure will continue to support Sensible in its transition to a new marketing and distribution arrangement in order to secure its investment in Sensible Medical.

Read More

BUSINESS INSIGHTS

Applied BioMath, LLC Announces Collaboration with BYOMass™ for Systems Pharmacology Modeling in Oncology

Applied BioMath | October 18, 2021

Applied BioMath, the industry-leader in applying systems pharmacology and mechanistic modeling, simulation, and analysis to de-risk drug research and development, today announced a collaboration with BYOMass, Inc. for systems pharmacology modeling in chronic diseases. BYOMass is a preclinical stage pharmaceutical company focused on the TGF-ß superfamily. "We chose Applied BioMath given their proven track record of helping companies identify ideal therapeutic properties and platforms, We hope that this collaboration will help us identify the properties of a lead candidate as efficiently as possible and aid in the design of future studies." - Margaret Jackson, D.Phil., Founder and CEO of BYOMass Applied BioMath employs a rigorous fit-for-purpose model development process which quantitatively integrates knowledge about therapeutics with an understanding of its mechanism of action in the context of human disease mechanisms. Their approach employs proprietary algorithms and software that were designed specifically for systems pharmacology model development, simulation, and analysis. "We often work with early-stage companies to help them understand what their therapeutic needs to look like in order to be best in class, We look forward to collaborating with BYOMass and helping them decide next steps for this project." - John Burke, PhD, Co-Founder, President, and CEO of Applied BioMath. About Applied BioMath Founded in 2013, Applied BioMath's mission is to revolutionize drug invention. Applied BioMath uses mathematical modeling and simulation to provide quantitative and predictive guidance to biotechnology and pharmaceutical companies to help accelerate and de-risk drug research and development. Their approach employs proprietary algorithms and software to support groups worldwide in decision-making from early research through clinical trials. The Applied BioMath team leverages their decades of expertise in biology, mathematical modeling and analysis, high-performance computing, and industry experience to help groups better understand their candidate, its best-in-class parameters, competitive advantages, patients, and the best path forward into and in the clinic.

Read More

AbbVie, Amgen and Takeda Take Collaborative Efforts to Tackle COVID-19

Fiercepharma | August 03, 2020

The drug industry has come together in unprecedented collaborative efforts to tackle COVID-19. Now, as part of an R&D alliance, three big drugmakers are running a joint clinical trial to see whether their products can improve outcomes for severely ill patients. A recently launched clinical program, dubbed I-SPY, will test Amgen’s psoriasis med Otezla, Takeda’s hereditary angioedema therapy Firazyr and AbbVie’s experimental nonalcoholic steatohepatitis drug cenicriviroc to see if they can tamp down potentially life-threatening immune overreaction seen in some serious COVID-19 patients, the three companies said Monday. The primary endpoint of the study is time for severe COVID-19 patients on high-flow oxygen support to improve at least 1 point on an 8-point World Health Organization ordinal COVID status scale for at least 48 hours.

Read More

Spotlight

Regulations allowing compassionate use of investigational drugs have been in effect since 1987, when public anger about the slow pace of approvals for HIV/AIDS drugs resulted in rules allowing greater access to drugs in development. Last year, the FDA updated its rule to expand the patient categories that may have rights to use unapproved drugs and to clarify requirements for expanded-access programs. The old system allowed individual patients access to investigational drugs through an emergency IND system, while large groups received access through treatment protocols. Under the new rule, the FDA allows access to unapproved drugs on a case-by-case basis for single patients, small groups of patients with similar treatment needs and even larger groups of 100 patients or more. In addition, the term “serious illness” has been redefined to include a much broader array of conditions.