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Center for Breakthrough Medicines and BioAnalysis LLC Form Strategic Alliance to Offer Novel Analytical Testing Services for CGT Clients

CBM is a cell and gene therapy contract development and manufacturing organization

KING OF PRUSSIA, Pa., February 23, 2022 — The Center for Breakthrough Medicines (CBM) announced today that it has entered into an strategic agreement with BioAnalysis LLC (BIA) to provide CBM’s clients with direct access to BIA’s advanced testing capabilities, including characterization of viral vectors using BIA’s proprietary sedimentation velocity approach to analytical ultracentrification (“SV-AUC”), as well as other advanced biophysical methods and analytics.

Dr. Lake Paul, founder and principal scientist at BIA, is regarded as a leader in the field and is frequently engaged to conduct rigorous evaluation of gene therapy products and processes. Through this strategic alliance, CBM gains the expert scientific and data analysis provided by Dr. Paul and his team, an invaluable resource for CBM clients in need of sophisticated assay and method development and a trusted cGMP-compliant laboratory for characterization and advanced analytical methods.

“We could not be more delighted to partner with Dr. Paul and the BIA team – the next generation testing capabilities they bring to the table for CBM’s innovator clients will be a game-changer,” says Dana Cipriano, Senior Vice President of Testing and Analytical Services at Center for Breakthrough Medicines. “As a CDMO collaborator, BIA has found the perfect match in CBM,” says Dr. Paul, adding “Our testing capabilities are unrivaled, and the sophisticated innovator clientele CBM connects with BIA will be a true differentiator in the CGT analytical testing space.”

About The Center for Breakthrough Medicines
CBM is a horizontally integrated cell and gene therapy contract development and manufacturing organization (CDMO). CBM offers fully integrated, bench to bedside, pre-clinical through commercial manufacturing capabilities including, process development, plasmid DNA, viral vector manufacturing, cell banking, cell processing, and a full suite of complimentary testing and analytic capabilities. CBM’s innovative horizontal integration enables the utmost quality and accelerates time to market and affordability of advanced therapies from discovery to commercialization without compromising quality through a single-source, end-to-end solution, providing the opportunity for incubators, academics, researchers, and companies small to large to align with the most comprehensive manufacturing partner in the industry.

About BioAnalysis LLC.
Bioanalysis LLC is an agile, non-clinical CRO (Contract Research Organization) that provides answers to the toughest questions with scientifically in-depth analyses. With our deep experience in Analytical Method Development, GMP Validation, CMC Strategy, and Quality Control, we help improve science at every stage of the product lifecycle. We specialize in Biophysics and Mass Spectrometry applications for Gene Therapy, mAbs, Therapeutic Proteins, ADCs, and Nanoparticles.

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L to R: Audrey Greenberg, Co-Founder Center for Breakthrough Medicines; Lake Paul, PhD, Founder and President BioAnalysis; Dana Cipriano, Senior Vice President of Testing and Analytical Services, Center for Breakthrough Medicines.

 

Media Contact:
John F. Kouten, DeFazio Communications
(o) 609-241-7352 (c) 908-227-4714
John@defaziocommunications.com

 

February 23, 2022

This KOP-Kensington partnership aims to speed the advancement of cell and gene therapies

Two life science orgs in the Greater Philadelphia region are partnering to advance cell and gene therapies more quickly.

King Of Prussia’s Center for Breakthrough Medicines (CBM), a cell and gene therapy contract developer and manufacturer at Discovery Labs, has entered a strategic partnership with BioAnalysis LLC, a Kensington-based nonclinical contract research organization.

Through the partnership, five-year-old BioAnalysis, based out of MaKen Studios, will bring its testing capabilities to the Center’s client companies. Those capabilities include characterization of viral vectors using the Kensington company’s proprietary sedimentation velocity approach to analytical ultracentrification, along with other biophysical methods and analytics, the partners said Wednesday. BioAnalysis founder and principal scientist Lake Paul will lend scientific expertise and data analysis, as his team becomes an “invaluable resource” for the Center’s clients.

The patients who are expected to benefit most from this partnership include those who suffer from rare diseases.

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Center for Breakthrough Medicines’ new lab testing arm could add over 400 jobs

The Center for Breakthrough Medicines develops Adenovirus Vector Technology

The laboratory will address escalating capacity needs for life sciences companies in the cell and gene therapy sector.

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February 17, 2022

Center for Breakthrough Medicines Launches Analytical Testing Services for Advanced Therapies, Bringing Solutions to a Supply-Constrained Industry

Testing Business Unit Will Grow to More Than 400 Employees, Eliminate Wait Times, and Enable Faster Release Times for The Pharma Industry

KING OF PRUSSIA, Pa., January 16, 2022 — The Center for Breakthrough Medicines (CBM) announced the opening of their analytical testing services laboratories that will deliver the most comprehensive testing capabilities in the industry. These vital service offerings address growing capacity needs in the severely supply-constrained cell & gene therapy market.

More than 2,500 submissions are currently under review in the Food and Drug Administration’s (FDA) cell and gene therapy pipeline. This volume, combined with FDA’s increased scrutiny, has caused bottlenecks for product release results, with testing queues of up to 8 months. By 2025, the FDA expects to receive upwards of 200 investigational new drug (IND) applications for cell and gene therapies annually, with an estimated approval of 10 to 20 cell and gene therapies each year. This unprecedented growth comes with challenges, particularly in testing. Tremendous backlogs in critical long-lead assays across the industry are leading to 6–12-week delays for cell-based methods, safety assays, and advanced analytics.

CBM’s Testing and Analytical Services provides an integrated and comprehensive portfolio of services to its clients all on one campus located in the heart of Philadelphia’s Cellicon Valley, with a goal to dramatically shorten development timelines, greatly reduce regulatory risks and accelerate cures for patients. CBM’s testing services will support custom assay development, characterization, and release for cell and gene therapy products, as well as for biologics, vaccines and plasmids. Regardless of a company’s development stage, CBM offers tailored solutions from IND through commercialization and lot release.

“Our laboratories support R&D and GMP testing services, enabling the continued expansion of the on-site capabilities that can be scaled up at our expansive King of Prussia facility,” said Dana Cipriano, Senior Vice President of Testing and Analytical Services, Center for Breakthrough Medicines. “Our testing service is backed by strong scientific expertise and advanced analytical equipment and is located across the hall from our Process Development and Manufacturing Operations, allowing us to offer a complete on-site end to end service for our manufacturing clients as well as the option for standalone external testing for our clients.

CBM’s Comprehensive Testing Capabilities & Massive Expansion Plan

CBM’s Testing and Analytical Services business occupies approximately 200,000 sq ft across four buildings along with a stand-alone safety testing laboratory segregated from GMP operations on one campus. In addition to massive analytical development capabilities, the campus has advanced analytics at the forefront of the operation, including the following components:

  • CBM dedicated Bioassay lab that supports potency assay development with a “partner-in-plant” philosophy welcoming CBM’s clients to promote early development of these methods and provide a progressive approach to development throughout a product’s life cycle.
  • CBM dedicated analytical lab to support assay development, full product and process characterization, as well as release testing.
  • CBM next-generation sequencing (NGS) and molecular biology laboratories for full product characterization early in product development through commercial approval.
  • CBM validated testing platforms to support gene therapies, cell therapies, biologics, vaccines and plasmids.
  • CBM dedicated stability labs to support International Council for Harmonization (ICH) Q2 Stability programs.

CGT Industry’s Most Comprehensive Analytical Testing Capability on One Campus

“CBM’s Testing and Analytical Services business has a concentrated focus on meeting the unprecedented market demand where testing queues are at all-time highs,” said Joerg Ahlgrimm, President and CEO, Center for Breakthrough Medicines. “Clients and patients need in-process and product release testing, and CBM can meet this need. We provide speed to market by expediting the path to approval by utilizing advanced analytical methods and platform assays to demonstrate potency, purity, identity, and safety for FDA approval.”

CBM’s Testing and Analytical Services strengthen the company as a leading contract testing business, making testing a key strategic asset supporting the contract development and manufacturing organization (CDMO), and helps fill an extensive and growing analytical testing shortage in the CGT industry.

“We are aggressively attacking the testing market through our massive execution and delivery of the most comprehensive analytical testing capability in the CGT industry located on one campus,” said Audrey Greenberg, Co-founder and Chief Business Officer of Center for Breakthrough Medicines. “Our integrated manufacturing and testing services provide quality and speed – robust and unique advantages for our clients.”

About The Center for Breakthrough Medicines
CBM is a cell and gene therapy contract development and manufacturing organization (CDMO) based in the heart of Philadelphia’s Cellicon Valley. CBM offers pre-clinical through commercial manufacturing capabilities including process development, plasmid DNA, viral vector manufacturing, cell banking, cell processing, and a full suite of complimentary testing and analytical capabilities. Through a single-source, end-to-end solution, CBM accelerates time to market without compromising quality.

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Media Contact:
John F. Kouten, DeFazio Communications
(o) 609-241-7352 (c) 908-227-4714
John@defaziocommunications.com

 

February 16, 2022

Audrey Greenberg on Money Matters TV 22-6 with Donna De Carolis

CBM is a CDMO focused on Assay and Bioassay Testing

Money Matters TV, hosted by Center for Breakthrough Medicines Co-Founder Audrey Greenberg and Brandywine Asset Management Founder & CEO Michael Dever, covered a wide range of topics, including the use of AI to identify candidates for clinical trials, as well as Philadelphia’s continued growth in lifesciences and record-breaking year of capital investment. “We’re excited about the use of proven, FDA approved modalities within advance therapies, such as cell therapy, gene therapy gene editing and mRNA, being applied to larger populations,” Greenberg reported. Guest Donna M. De Carolis also discussed entrepreneurship education and its importance to the Philadelphia economy and developing the next generation of entrepreneurs to bring these innovations to life.

February 3, 2022