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Developing, manufacturing and testing of biopharmaceuticals | Alava Biopharm Partners

Network & Partners. News & Events. Development and budget planning. Partnering assessment and diligence. Nonclinical development and toxicology. Process and Analytical Development. GMP Operations and QC. Small molecule (oral, injectable). Vaccines (viral, bacterial, recombinant). Fab fragments and fusion proteins. Recombinant proteins (E. coli, yeast, bacteria). Every biopharm project has its technical challenges. Our team has the technical training and industry experience to solve tough problems, mi...

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Developing, manufacturing and testing of biopharmaceuticals | Alava Biopharm Partners | alavabp.com Reviews
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Network & Partners. News & Events. Development and budget planning. Partnering assessment and diligence. Nonclinical development and toxicology. Process and Analytical Development. GMP Operations and QC. Small molecule (oral, injectable). Vaccines (viral, bacterial, recombinant). Fab fragments and fusion proteins. Recombinant proteins (E. coli, yeast, bacteria). Every biopharm project has its technical challenges. Our team has the technical training and industry experience to solve tough problems, mi...
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Developing, manufacturing and testing of biopharmaceuticals | Alava Biopharm Partners | alavabp.com Reviews

https://alavabp.com

Network & Partners. News & Events. Development and budget planning. Partnering assessment and diligence. Nonclinical development and toxicology. Process and Analytical Development. GMP Operations and QC. Small molecule (oral, injectable). Vaccines (viral, bacterial, recombinant). Fab fragments and fusion proteins. Recombinant proteins (E. coli, yeast, bacteria). Every biopharm project has its technical challenges. Our team has the technical training and industry experience to solve tough problems, mi...

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Project Management | Alava Biopharm Partners

http://www.alavabp.com/project-management

Network & Partners. News & Events. Development and budget planning. Partnering assessment and diligence. Nonclinical development and toxicology. Process and Analytical Development. GMP Operations and QC. If a client has project management support for CMC activities, Alava team members can take care of the project tasks. If support is needed, Alava will supply an experienced CMC-focused project manager and help integrate CMC with clinical, regulatory and operational aspects of the project.

2

Quality Assurance | Alava Biopharm Partners

http://www.alavabp.com/quality-assurance

Network & Partners. News & Events. Development and budget planning. Partnering assessment and diligence. Nonclinical development and toxicology. Process and Analytical Development. GMP Operations and QC. QA document system startup and maintenance. Quality Agreements for CMO’s and testing labs. Batch Record and Testing Record review and approval. QA audits and Pre-Approval Inspection preparation. Facility and utility validation and compliance. Investigations and compliance remediation.

3

Cellular and Gene Therapies | Alava Biopharm Partners

http://www.alavabp.com/cellular-and-gene-therapies

Network & Partners. News & Events. Development and budget planning. Partnering assessment and diligence. Nonclinical development and toxicology. Process and Analytical Development. GMP Operations and QC. Cellular and Gene Therapies. Alava’s project list includes multiple CIRM-funded cellular therapy projects, nucleic acid based therapies, and diligence on inlicensing and acquisition opportunities (including a diligence project for a top pharmaceutical company). Alava team members have strong experien...

4

Technical Development | Alava Biopharm Partners

http://www.alavabp.com/technical-development

Network & Partners. News & Events. Development and budget planning. Partnering assessment and diligence. Nonclinical development and toxicology. Process and Analytical Development. GMP Operations and QC. Process and Product Development Expertise:. Cell line development and GMP banking. Supply and characterization of tox material. Downstream process development and viral clearance studies. Formulation and drug product development. Stability assessment, shipping and storage. Cell based and potency bioassays.

5

News & Events | Alava Biopharm Partners

http://www.alavabp.com/news-and-events

Network & Partners. News & Events. Development and budget planning. Partnering assessment and diligence. Nonclinical development and toxicology. Process and Analytical Development. GMP Operations and QC. Alava Biopharm Partners expands, offers nonclinical development and regulatory affairs consulting along with CMC support. Filed Under: Alava Updates. Small molecule (oral, injectable). Vaccines (viral, bacterial, recombinant). Fab fragments and fusion proteins.

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Developing, manufacturing and testing of biopharmaceuticals | Alava Biopharm Partners

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