Your PREFERRED CDMO Partner

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Your Preferred CDMO Partner

As a Contract Development Manufacturing Organization (CDMO), we fast-track the clinical development of your biologic for regulatory approval, manufacture your biologic below market price,  and accelerate your drug products into the global commercial market for sale. Alongside our cGMP manufacturing facility, we also have a Commercial Life Science Co-Working / Wet Lab Facility. These co-working spaces / labs allow our Partners (customers) to continue their R&D work within a cGLP/cGMP managed laboratory environment to successfully grow their drug product pipeline as well as their company.

LucasPye BIO is operating in partnership with

MidwestBio
Our mission is to make biotherapeutic drugs more affordable while transforming the economy and strengthening the healthcare offerings within various communities around the globe. We will be located in Philadelphia, PA. Our location is significant in allowing LucasPye BIO to change the narrative and “face” of the biotechnology industry to one that promotes and illustrates real-world diversity, inclusion & equality.

We Are The 1st

Our Virtual Business Operations help to streamline your day-to-day company operations for clinical development of your drug product as well as management of your drug product within the global commercial market post-regulatory approval. As a LPB Partner, you will have access to our E-Documentation Cloud Software to perform/execute:

  • R&D, including QbD & Change Management during Pre-Clinical Development
  • Mobile/Web Apps to receive real-time invoicing for raw materials and completed project deliverables
  • Review/Approve batch documentation, i.e. Batch Records, Change Controls, SOPs, Nonconformance Investigations & Deviation Reports
  • Approve/Release batches for for clinical use and/or sale in the global commercial market

Our E-Documentation Cloud Software also allow LPB Partners to file/manage the following for global regulatory approval:

  • INDs
  • BLAs
  • Clinical Trial Management
  • Trial Master Files (TMF)
  • Post-Marketing Documentation

As a LPB Partner, you will have access to our internal Drug Product Sales Team (DPS Team). The DPS Team in partnership with our Marketing Team will help you successfully promote and sell your drug product in the global commercial market. Their capabilities extend to placing your regulatory-approved drug product on the prescription menus of Medical Payers, both private and public (i.e. Private Health Insurers and Government Organizations / Affiliates).

Facility Information

LucasPye BIO cGMP Bioprocessing Facility

LucasPye BIO’s cGMP Bioprocessing Facility will be a 60,000 square feet iCON Facility – built by IPS-Integrated Project Services, LLC in conjunction with G-CON Manufacturing.

60,000 sq. ft. equipped with the GE FlexFactory Single-Use Platform to manufacture Mammalian Cell Lines, including both CHO and NS0 cell lines. The facility will also house a Media Formulation Suite, Buffer Formulation Suite, Harvest Suite and Purification Suite for Drug Substance Bioprocessing.

Equipment List

  • 2 x Wave 25 Rockers
  • 2 x 200L Xcellerex Bioreactors
  • 2 x 2000L Xcellerex Bioreactors
  • Millistak+ Pod Clarification Harvest System 
  • 4 x AKTA XL Purification Systems
  • 2 x AKTA TFF Ultrafiltration/Diafiltration Systems

Click Here for a Virtual Tour of our Manufacturing Facility Prototype

 Our QC Laboratories house industry-standard equipment and amenities per cGLP and cGMP to perform:
  • Analytical Method Development & Validation Operations
  • Stability Analytics, including sample vial storage rooms
  • Analytical Methods and Validation Operations for cGMP Environmental Control

The Commercial Life Science Co-Working / Wet Lab Facility will be built next door to our cGMP Bioprocessing Facility. It will be staffed with personnel to manage the laboratories per global regulatory standards. The wet labs & co-working spaces will incorporate the appropriate E-Documentation Cloud Software & Virtual Business Operations Software to facilitate Cooperative Communication and Day-to-Day Business Operations between your team and LucasPye BIO.

The LPB cGMP Bioprocessing Facility and Commercial Life Science Co-Working / Wet Lab Facility will be located within a Lifestyle Campus to support the needs of your team, their families and your customers. This campus will include high-quality amenities such as Residential Real Estate, Day Care, Hotel, Restaurants, Retail Stores, and much more.

Who are we?

CEO at Black Pearl Global Investments

Ph.D. Biomedical Science / Neurological Surgery, Ohio State University

MBA, Queens University of Charlotte

B.Sc. Chemistry, Winston-Salem State University

Advisory Board Member

Pharmaceutical and Regulatory Compliance Expert with more than 18 years of Industry Experience

Process Development / Scale-Up Advisor to several large cap biopharmaceutical companies

Global Regulatory Author for Clinical Trial / Commercial Market Authorization, i.e. IND, NDA and BLA

Key Opinion Leader in Stainless Steel (SS) and Single-Use (SU) Bio-Manufacturing Equipment for Cell Culture / Purification Manufacturing Operations

Former Employers: HUCC, NIH, WRAIR, Human Genome Sciences, Amgen, Baxter, Avid Bioservices, Lonza

Former Consultant @ Jazz Pharmaceuticals

MRSc Regulatory Science, University of Southern California

B.Sc. Biology, Howard University

Founder & CEO

Corporate Contract Accounting Expert with more than 12+ years of Industry Experience

Key Opinion Leader in Accounts Receivables & Accounts Payable Management

Technical skills in Oracle, SAP, MS Applications, Hyperion, Crystal Reports, AS400, ADP, Paychex, Sage, Lawson, HCSIS, Promise, DelTek, etc.

Client List – GSK, Sunoco, Duane Morris, Catapult Learning, Towers Watson, Associated Global Systems, Day and Zimmerman

B.Sc. Accounting, Arizona State University

CFO

Over 10+ Years Experience in the biotechnology / biopharmaceutical industry – Operations Management, Talent Development, Organization Management & Change Management

Former Employers: U.S. Army, Genetech & Lonza

Extensive experience in managing people and operations w/in a mammalian manufacturing facility as well as talent development/management of people w/in a biotech/biopharma company – reporting directly to Executive Management

MBA, Northeastern University

B.Sc. Physics, Boston College

Director – Human Resources

Over 20+ Years Experience in the biotechnology / biopharmaceutical industry – Quality Control, Quality Assurance, & Engineering/Design (QbD)

Former Employers: Everyday, Pfizer, Monsanto, Medtronic, Unilever, ABC Laboratories & Lonza

Extensive experience in operating & managing QC Operations, including laboratory techniques/analytics; QA Operations, including batch review/ disposition, investigations/reporting, site auditing & manufacturing facility design per regulatory requirements.

B.Sc. Chemistry, Evangel University & B.Sc. Business Administration

Director – Quality

Over 20+ Years Experience in the biotechnology / biopharmaceutical industry – operations & management of staff for mammalian cell line manufacturing

Former Employers: Medimmune, Human Genome Sciences, AstraZeneca & GSK

Managed operations w/ stainless steel & single-use equipment; design/ implementation of electronic batch records (EBR); design & execution of manufacturing facility build-outs; designing & executing operations staff (including training programs)

B.Sc. Chemistry, Coppin State University

Director – Mammalian 
Manufacturing

Over 20+ Years Experience in the biotechnology/ biopharmaceutical industry – Clinical Trial Supply, including Packaging & Labeling

Former Employers: Inovia Pharmaceuticals, Merck, Johnson & Johnson, AstraZeneca, Astra Merck, & Jazz Pharmaceuticals

Extensive experience in Clinical Compliance, Clinical Safety, Clinical Data Management Ops, Clinical Research, Regulatory Affairs, Drug Development

Supply Chain Mgmt. Certification, Villanova University

Clinical Research Certification, Villanova University

B.A. Psychology & Social Science, Pennsylvania State University

M.S. Pharmaceutical Healthcare Business, University of Sciences

Director – Marketing / Packaging / Labeling

Over 25+ Years Experience in the biotechnology / biopharmaceutical industry – Chemist, Sales, Project Management & Portfolio Management

Former Employers: Pfizer, J&J Merck, Janssen, URL Pharma, Johnson & Johnson, PuraCap Pharmaceutical, Merck, AbbVie & Jazz Pharmaceuticals

Extensive experience in Laboratory Techniques & Analytics; Highly knowledgeable on GXP & Regulatory Affairs; Managing Global Executive-tier projects, i.e.Large-Cap Projects

B.Sc. Behavioral Neuroscience & Chemistry, University of Pittsburgh

M.Sc. Physical Chemistry, Drexel University

MBA, Tulane University

PMP Certification, Penn State University

Director – Project Management

Over 15+ Years Experience in the Information Technology (IT) industry – Computer Hardware & Software support within Windows, Mac, and Linux; Server Administration; and network configuration & management, including cloud software / local data servers & security.
 
Former Employers: Jazz Pharmaceuticals, ICIMS, Burlington Coat Factory (Corporate), Educational Testing Service (ETS), and Advanced Surgery Center.
 
Extensive experience working with multiple industry-standard software, operating systems, and hardware; including Microsoft, Salesforce, Migration Wizard; IBM, Dell, Epson, Lenovo, and Acer just to name a few.
 
Cisco Certified Network Associate; Microsoft Certified Systems Administrator; and Network Systems Professional via The Cittone Institute

Director – IT

Over 10+ Years Experience in Business Administration, including Human Resources, Corporate Account Management, and Administration Operations for Federal & State Government Agencies.
 
Former Employers: American Express, NYC Department of Health, U.S. Treasury Department, NYC Department of Education, Fish & Goding, Verizon Wireless, and Alpha Plasma Center
 
B.Sc. Human Resource Management, Park University

Executive Operations Manager

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