Sharepoint Solutions

PRODUCTS

  • Pharmatec Fermentation Systems and Fermentation Units are designed for the production of complex solutions with multiple process steps (cascade, fermentation or dialysis fermentation). Preparation is carried out in temperature-controlled stainless steel tanks with stirring units under addition of chemicals and/or nutrient solutions. The following process steps are used: fumigation (N2, O2 and sterile air), dosage (substrate and anti-foam), concentration (base and acid). All valid pharmaceutical (e. g. USP, EP) and technical rules and standards (e. g. DIN, ASME, GMP and FDA / ISPE Guidelines) are followed and applied.

  • Schenck Process Group Baker Perkins offer complete, fully-automated systems for mixing, cooking and applying coatings to breakfast cereals.

  • With over 20 years of experience, PCI’s strength lies in our ability to manage products with unique challenges ranging from small molecules presenting with solubility issues or a labile molecule that is only stable as a liquid presentation for a short time.

  • The United States Pharmacopeia USP 1207 guidance has been revised, encouraging the preference to deterministic, quantitative, and reliable non-destructive technologies to comply with quality standards.

  • Robust quality and regulatory support protects our clients and ultimately patients.

    Focus on compliance and continuous improvement

    At the Center for Breakthrough Medicines, our quality management systems and regulatory services provide the highest level of compliance, control, and oversight for our client programs from the inception of the clinical trial through commercialization. Having a dedicated regulatory team on site supporting your program will allow for real-time process information and analytical data to be procured, evaluated, and applied to your submission filing. The requirements of an IND/BLA are complicated and can be difficult to interpret. By partnering with CBM, we can utilize our strong relationships with the health authorities and collaborate with you to make sure your filing meets the stringent requirements set forth by the agencies, minimizing any potential delays to your program resulting from the review process.

WHITE PAPERS AND CASE STUDIES

NEWS

  • EPA Invites 39 New Projects To Apply For Water Infrastructure Loans
    12/3/2021

    Today, the U.S. Environmental Protection Agency (EPA) announced that 39 new projects are being invited to apply for Water Infrastructure Finance and Innovation Act (WIFIA) loans and 4 projects are being added to a waitlist.

  • EPA WIFIA Annual Report Celebrates Over $5B In Water Infrastructure Loans
    3/24/2022

    Today, the U.S. Environmental Protection Agency (EPA) released the 2021 Water Infrastructure Finance and Innovation Act (WIFIA) Annual Report. The report highlights the program’s 2021 investments in water infrastructure to protect public health and the environment, create good-paying jobs, and save communities money over alternative financing options.

  • Antheia Announces Plans To Construct New Biomanufacturing Pilot Plant Facility In California
    6/22/2022

    Antheia, a synthetic biology company enabling next-generation plant-inspired medicines, today announced $40 million in venture debt financing from Oxford Finance LLC and Silicon Valley Bank, alongside plans to construct a new pilot scale biomanufacturing facility. The financing will support Antheia's expansion with a 14,700 square-foot pilot plant located next to Antheia's headquarters in Menlo Park, CA. The new pilot plant will enable the company to significantly improve efficiency and support the scale up of its growing portfolio of products.

  • WRF Funds 22 New Projects To Advance The Science Of Water
    6/11/2022

    The Water Research Foundation (WRF) will soon post Requests for Proposals (RFPs) and is seeking volunteers for 22 new research projects funded through WRF's Research Priority Program.

  • NAWC Applauds Reps. Garamendi, Bost For Introduction Of Clean Water SRF Parity Act
    7/23/2021

    US Representatives Garamendi (D-CA-03) and Bost (R-IL-12) introduced the Clean Water SRF Parity Act (H.R. 4597) on Thursday. This legislation would amend eligibility provisions for the Federal Water Pollution Control Act’s Clean Water State Revolving Fund (clean water SRF), so that all wastewater customers have the ability to benefit from the program’s low-interest loans.