BACE EXAMS 2026 FINAL PAPER SOLVED
ITEMS ACCURATE MARKING
◉ key activities of upstream processing. Answer: cell line
development, cell culture, fermentation, optimization and scale up,
and harvesting
◉ Cell line development. Answer: Key activity of upstream
processing that involves selection (choosing/engineering of cell line
to produce product)
◉ Cell line development. Answer: Key activity of upstream
processing that involves screening and characterization (evaluating
cell line to ensure it meets required criteria for productivity and
stability)
◉ Cell culture. Answer: Key activity of upstream processing that
involves preparing media, inoculation, and cultivation
◉ Fermentation. Answer: Key activity of upstream processing that
involves operating bioreactors to cultivate microorganisms and
optimizing to adjust for yield and efficiency
,◉ Optimization and Scale-up. Answer: Key activity of upstream
processing that involves fine-tuning conditions and scaling up lab to
production scale while maintaining product consistency
◉ Harvesting. Answer: Key activity of upstream processing that
involves collecting cells and biomass with product (could involve
centrifugation or filtration to separate from culture medium
◉ Downstream processing. Answer: Stages after upstream
processing where the focus shifts to purifying, formulating, and
prepping final product
◉ Cell Disruption. Answer: Key activity of downstream processing
that involves lysis, disrupting cells to release the product if the
product is intracellular. Techniques include mechanical disruption,
chemical lysis, or enzymatic methods
◉ Clarification. Answer: Key activity of downstream processing that
involves using centrifugation or filtration to remove cell debris and
other particulates from the product-containing solution
◉ Purification. Answer: Key activity of downstream processing that
involves using chromatography (affinity, ion exchange, size
exclusion) and filtration to remove impurities
,◉ Formulation. Answer: Key activity of downstream processing that
involves preparing buffers and excipients, and formulation, where
the final product is combined with stabilizers, preservatives, or
other ingredients to create the final formulation
◉ Sterilization. Answer: Key activity of downstream processing that
involves applying methods such as filtration or heat to ensure that
the product is sterile and free of microbial contamination.
◉ Filling and Packaging. Answer: Key activity of downstream
processing that involves filling the final product into appropriate
containers, such as vials or syringes, and packaging the product to
ensure stability and compliance with regulatory requirements.
◉ Quality Control (step in processing biopharmaceuticals). Answer:
Key activity of downstream processing that involves extensive
testing to ensure the final product meets all quality and safety
standards. This includes testing for potency, purity, sterility, and
other relevant attributes
◉ Atrributable. Answer: Part of Good Documentation Practices
(GDocP) that states that entries must be traceable to the individual
who performed action or recorded the data (via signature and
initials; electronic records, with things like e-sign in, User ID's, etc;
and access controls, which keeps record of who edits which specific
documents)
, ◉ Legible. Answer: Part of Good Documentation Practices (GDocP)
that states that documentation must be clear and readable
(handwritten records must be clear and legible, avoiding unclear
abbreviations; and electronic records must be displayed in readable
format and be easy to navigate.
◉ Contemporaneous. Answer: Part of Good Documentation
Practices (GDocP) that states that records must be made at the time
the activity occurs or shortly there after (using real time entry to
document results as they happen, which reduces risk of inaccuracy
or omission; and timely updates to ensure that any changes to
documentation are made promptly after the activity or observation)
◉ Original. Answer: Part of Good Documentation Practices (GDocP)
that states that initial records must be preserved as the original
source of info (original entries should be maintained with no
alterations and it should be ensured that corrections are proper and
clear; and e-records should use secure systems to preserve original
records, and care must be taken to avoid deleting or modifying
records without documentation.)
◉ Accurate. Answer: Part of Good Documentation Practices (GDocP)
that states that documentation must be correct and current. (Data
entry must be correct, ensuring data is accurate; and errors must be
corrected according to procedure.)
ITEMS ACCURATE MARKING
◉ key activities of upstream processing. Answer: cell line
development, cell culture, fermentation, optimization and scale up,
and harvesting
◉ Cell line development. Answer: Key activity of upstream
processing that involves selection (choosing/engineering of cell line
to produce product)
◉ Cell line development. Answer: Key activity of upstream
processing that involves screening and characterization (evaluating
cell line to ensure it meets required criteria for productivity and
stability)
◉ Cell culture. Answer: Key activity of upstream processing that
involves preparing media, inoculation, and cultivation
◉ Fermentation. Answer: Key activity of upstream processing that
involves operating bioreactors to cultivate microorganisms and
optimizing to adjust for yield and efficiency
,◉ Optimization and Scale-up. Answer: Key activity of upstream
processing that involves fine-tuning conditions and scaling up lab to
production scale while maintaining product consistency
◉ Harvesting. Answer: Key activity of upstream processing that
involves collecting cells and biomass with product (could involve
centrifugation or filtration to separate from culture medium
◉ Downstream processing. Answer: Stages after upstream
processing where the focus shifts to purifying, formulating, and
prepping final product
◉ Cell Disruption. Answer: Key activity of downstream processing
that involves lysis, disrupting cells to release the product if the
product is intracellular. Techniques include mechanical disruption,
chemical lysis, or enzymatic methods
◉ Clarification. Answer: Key activity of downstream processing that
involves using centrifugation or filtration to remove cell debris and
other particulates from the product-containing solution
◉ Purification. Answer: Key activity of downstream processing that
involves using chromatography (affinity, ion exchange, size
exclusion) and filtration to remove impurities
,◉ Formulation. Answer: Key activity of downstream processing that
involves preparing buffers and excipients, and formulation, where
the final product is combined with stabilizers, preservatives, or
other ingredients to create the final formulation
◉ Sterilization. Answer: Key activity of downstream processing that
involves applying methods such as filtration or heat to ensure that
the product is sterile and free of microbial contamination.
◉ Filling and Packaging. Answer: Key activity of downstream
processing that involves filling the final product into appropriate
containers, such as vials or syringes, and packaging the product to
ensure stability and compliance with regulatory requirements.
◉ Quality Control (step in processing biopharmaceuticals). Answer:
Key activity of downstream processing that involves extensive
testing to ensure the final product meets all quality and safety
standards. This includes testing for potency, purity, sterility, and
other relevant attributes
◉ Atrributable. Answer: Part of Good Documentation Practices
(GDocP) that states that entries must be traceable to the individual
who performed action or recorded the data (via signature and
initials; electronic records, with things like e-sign in, User ID's, etc;
and access controls, which keeps record of who edits which specific
documents)
, ◉ Legible. Answer: Part of Good Documentation Practices (GDocP)
that states that documentation must be clear and readable
(handwritten records must be clear and legible, avoiding unclear
abbreviations; and electronic records must be displayed in readable
format and be easy to navigate.
◉ Contemporaneous. Answer: Part of Good Documentation
Practices (GDocP) that states that records must be made at the time
the activity occurs or shortly there after (using real time entry to
document results as they happen, which reduces risk of inaccuracy
or omission; and timely updates to ensure that any changes to
documentation are made promptly after the activity or observation)
◉ Original. Answer: Part of Good Documentation Practices (GDocP)
that states that initial records must be preserved as the original
source of info (original entries should be maintained with no
alterations and it should be ensured that corrections are proper and
clear; and e-records should use secure systems to preserve original
records, and care must be taken to avoid deleting or modifying
records without documentation.)
◉ Accurate. Answer: Part of Good Documentation Practices (GDocP)
that states that documentation must be correct and current. (Data
entry must be correct, ensuring data is accurate; and errors must be
corrected according to procedure.)
